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NCTID: NCT02170090

Title: Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer 
Study Summary: This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC. 
Sponsor: Universitätsklinikum Hamburg-Eppendorf 
Intervention: Gemcitabine 
Start Date: 2014-04 
Last Updated: 2023-01-25 
Number of Patients: 789 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cholangiocarcinoma 

NCTID: NCT03473756

Title: Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma 
Study Summary: FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment.  The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.  The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.  Of note, patients who participate in Part A are not allowed to participate in Part B.  Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.  Part B of the study will no longer be conducted. 
Sponsor: Bayer 
Intervention: Rogaratinib (BAY1163877) 
Start Date: 2018-05-15 
Last Updated: 2023-11-14 
Number of Patients: 37 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urothelial Carcinoma 

NCTID: NCT05802290

Title: NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN 
Study Summary: Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent. This study is designed to better evaluate the safety profile of nivolumab in a large series of patients with Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck. The primary endpoint of this study is the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events. 
Sponsor: Gruppo Oncologico del Nord-Ovest 
Intervention: Nivolumab 240 MG in 24 ML Injection 
Start Date: 2017-11-27 
Last Updated: 2023-04-06 
Number of Patients: 124 
Recruitment Status: COMPLETED 
Condition: Squamous Cell Carcinoma of Head and Neck 

NCTID: NCT04052997

Title: Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma 
Study Summary: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL). 
Sponsor: ADC Therapeutics S.A. 
Intervention: Camidanlumab Tesirine 
Start Date: 2019-09-13 
Last Updated: 2023-03-31 
Number of Patients: 117 
Recruitment Status: COMPLETED 
Condition: Relapsed Hodgkin Lymphoma 

NCTID: NCT02178956

Title: A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer 
Study Summary: The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy. 
Sponsor: Sumitomo Pharma America, Inc. 
Intervention: BBI608 
Start Date: 2014-10 
Last Updated: 2023-11-15 
Number of Patients: 714 
Recruitment Status: COMPLETED 
Condition: Gastric Cancer 

NCTID: NCT03493854

Title: A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer 
Study Summary: This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Cyclophosphamide 
Start Date: 2018-06-14 
Last Updated: 2023-06-15 
Number of Patients: 500 
Recruitment Status: COMPLETED 
Condition: Early Breast Cancer 

NCTID: NCT04704154

Title: A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors 
Study Summary: Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.  In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.  The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).  The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.  During the trial, the doctors will take pictures of the participants’ tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants’ heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems. 
Sponsor: Bayer 
Intervention: Regorafenib, (Stivarga, BAY73-4506) 
Start Date: 2021-02-03 
Last Updated: 2023-11-28 
Number of Patients: 175 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Solid Tumors 

NCTID: NCT05514054

Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer 
Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. 
Sponsor: Eli Lilly and Company 
Intervention: Imlunestrant 
Start Date: 2022-10-04 
Last Updated: 2023-10-24 
Number of Patients: 6000 
Recruitment Status: RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT03770468

Title: Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma 
Study Summary: This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are:  * Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1) * Identification of molecular tumor characteristics in long-term survivors (Focus 2) * Assessment of therapy-related parameters, including neuro-toxicity (Focus 3) * Immunological studies (Focus 4) 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Blood drawl 
Start Date: 2015-07-05 
Last Updated: 2022-09-15 
Number of Patients: 599 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Glioblastoma 

NCTID: NCT04182516

Title: Study of NMS-03305293 in Pts With Selected Advanced/Metastatic Solid Tumors 
Study Summary: Phase I, first-in-human, open-label, multicenter, dose-escalation study with the aim of exploring safety, tolerability and preliminary antitumor activity of NMS-03305293 (a PARP inhibitor) as single agent in adult patients with selected advanced/metastatic, relapsed/refractory solid tumors who have exhausted standard treatment options or for whom standard therapy is considered unsuitable. 
Sponsor: Nerviano Medical Sciences 
Intervention: NMS-03305293 
Start Date: 2019-11-25 
Last Updated: 2022-03-18 
Number of Patients: 150 
Recruitment Status: RECRUITING 
Condition: Advanced/Metastatic Solid Tumors 

NCTID: NCT06095375

Title: Regorafenib in Combination With Temozolomide With or Without Radiotherapy in Patients With Newly Diagnosed MGMT-Methylated, IDH Wild-type Glioblastoma. 
Study Summary: This study will evaluate the addition of regorafenib to standard of care treatment with TMZ as adjuvant therapy, and in combination with TMZ+RT as concomitant therapy.  The standard of care for newly diagnosed GBM (ndGBM) includes surgical resection to the extent that is safely feasible, followed by RT plus concomitant TMZ chemotherapy, and up to 6 months of adjuvant TMZ.  The dose escalation will be explored following a “3+3” design, escalating oral doses of regorafenib in combination with adjuvant (maintenance) TMZ (cohort A) to estimate the MTD of regorafenib as adjuvant (maintenance) therapy. After finding the MTD in the Adjuvant Therapy dose escalation, the Concomitant Therapy (cohort B) dose escalation will start, exploring escalating oral doses of regorafenib in combination with concomitant TMZ+RT, to estimate the MTD of regorafenib as concomitant therapy. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Regorafenib 
Start Date: 2022-07-04 
Last Updated: 2023-10-23 
Number of Patients: 36 
Recruitment Status: RECRUITING 
Condition: Glioblastoma, IDH-wildtype 

NCTID: NCT04210115

Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) 
Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in:  * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants  The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:  * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: pembrolizumab 
Start Date: 2020-02-28 
Last Updated: 2023-11-27 
Number of Patients: 700 
Recruitment Status: RECRUITING 
Condition: Esophageal Squamous Cell Carcinoma (ESCC) 

NCTID: NCT03439215

Title: PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer 
Study Summary: This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria. 
Sponsor: Fondazione Ricerca Traslazionale 
Intervention: Lorlatinib 
Start Date: 2017-06-13 
Last Updated: 2021-07-19 
Number of Patients: 20 
Recruitment Status: UNKNOWN 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT04305054

Title: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) 
Study Summary: Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.  The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.  Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2020-07-01 
Last Updated: 2023-11-24 
Number of Patients: 315 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT03815643

Title: Avelumab Program Rollover Study 
Study Summary: The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Avelumab 
Start Date: 2019-03-22 
Last Updated: 2023-11-07 
Number of Patients: 161 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Solid Tumors 

NCTID: NCT02926222

Title: Regorafenib in Relapsed Glioblastoma 
Study Summary: This study aims to evaluate the role of Regorafenib in prolonging the overall survival of glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or without bevacizumab. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Regorafenib 
Start Date: 2015-11 
Last Updated: 2022-09-09 
Number of Patients: 119 
Recruitment Status: COMPLETED 
Condition: Glioblastoma Multiforme 

NCTID: NCT05730647

Title: Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients 
Study Summary: This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer.  The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment). 
Sponsor: Consorzio Oncotech 
Intervention: None intervention (observational study) 
Start Date: 2019-10-24 
Last Updated: 2023-02-16 
Number of Patients: 600 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT01523587

Title: LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy 
Study Summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients. 
Sponsor: Boehringer Ingelheim 
Intervention: afatinib 
Start Date: 2012-03-05 
Last Updated: 2019-02-15 
Number of Patients: 795 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT03763422

Title: Trial in Low Grade Glioma Patients: Wait or Treat 
Study Summary: The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Temozolomide 
Start Date: 2020-03-16 
Last Updated: 2022-02-01 
Number of Patients: 19 
Recruitment Status: TERMINATED 
Condition: Low-grade Glioma 

NCTID: NCT04622319

Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) 
Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: DS-8201a 
Start Date: 2020-12-04 
Last Updated: 2023-11-07 
Number of Patients: 1600 
Recruitment Status: RECRUITING 
Condition: HER2-Positive Primary Breast Cancer 

NCTID: NCT05623319

Title: Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC) 
Study Summary: This is an open-label, single arm, phase 2 trial enrolling patients with untreated Extensive-Stage Small-Cell Lung Cancer (ES SCLC), with a strong translational attitude. 
Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori 
Intervention: Pembrolizumab/Olaparib 
Start Date: 2023-03-27 
Last Updated: 2023-08-09 
Number of Patients: 60 
Recruitment Status: RECRUITING 
Condition: SCLC,Extensive Stage 

NCTID: NCT01689519

Title: A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma 
Study Summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator. 
Sponsor: Hoffmann-La Roche 
Intervention: Placebo 
Start Date: 2013-01-08 
Last Updated: 2022-05-02 
Number of Patients: 495 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT02654587

Title: Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor 
Study Summary: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens. 
Sponsor: OSE Immunotherapeutics 
Intervention: OSE2101 
Start Date: 2016-02 
Last Updated: 2021-03-08 
Number of Patients: 363 
Recruitment Status: UNKNOWN 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT05382286

Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer 
Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy 
Start Date: 2022-07-25 
Last Updated: 2023-11-15 
Number of Patients: 440 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer 

NCTID: NCT02162719

Title: A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors 
Study Summary: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors. 
Sponsor: Genentech, Inc. 
Intervention: Ipatasertib 
Start Date: 2014-08-19 
Last Updated: 2021-03-10 
Number of Patients: 124 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT01738633

Title: Quality of Life After Esophagectomy for Cancer - Step 2 
Study Summary: Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.  The study is divided into two steps.  This is step 2.  At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18. 
Sponsor: University of Padova 
Intervention: nutritional counseling 
Start Date: 2013-01 
Last Updated: 2018-05-23 
Number of Patients: 80 
Recruitment Status: TERMINATED 
Condition: Esophageal Cancer 

NCTID: NCT04211337

Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer 
Study Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. 
Sponsor: Loxo Oncology, Inc. 
Intervention: Selpercatinib 
Start Date: 2020-02-11 
Last Updated: 2023-10-30 
Number of Patients: 291 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Medullary Thyroid Cancer 

NCTID: NCT04895722

Title: Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) 
Study Summary: The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-06-25 
Last Updated: 2023-11-24 
Number of Patients: 320 
Recruitment Status: RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT03231722

Title: First Line mFOLFOXIRI + PANITUMUMAB vs mFOLFOX + PANITUMUMAB IN RAS AND BRAF WT METASTATIC COLORECTAL CANCER PATIENTS 
Study Summary: * The association of FOLFOX (5-fluoruracil, folinic acid, and oxaliplatin) and pan is a standard option for the first-line treatment of unresectable RAS and BRAF wt mCRC patients. * The phase III TRIBE trial recently demonstrated that FOLFOXIRI (5-fluoruracil, folinic acid, oxaliplatin and irinotecan) plus bev significantly prolongs PFS and OS and increases RECIST response rate, ETS and DoR, as compared to FOLFIRI (5-fluoruracil folinic acid, and irinotecan) plus bev. The advantage provided by the intensification of the upfront chemotherapy backbone is independent of RAS and BRAF mutational status. * Some phase II trials recently assessed the safety and activity of the combination of three-drugs chemotherapy regimens with an anti-EGFR monoclonal antibody. Promising activity results in terms of RECIST response rate and R0 resection rate have been achieved, with some safety concerns with special regards to gastrointestinal toxicity. * In the phase II randomized MACBETH study the combination of a modified schedule of FOLFOXIRI with cetuximab determined remarkable activity results, with an acceptable and manageable safety profile. * The optimal duration of the upfront treatment with chemotherapy plus anti-EGFRs is not established. The phase II MACRO-2 trial suggested that interrupting FOLFOX after 4 months while continuing cet alone as maintenance, is a reasonable option. * Activity parameters (RECIST response rate, ETS, DoR) are clinically relevant endpoints, associated with longer survival, in particular with anti-EGFR moAb-based treatment.  On the basis of these considerations, we designed the present phase III randomized trial of first-line mFOLFOXIRI plus pan versus mFOLFOX6 plus pan in RAS and BRAF wt unresectable mCRC patients. 
Sponsor: Gruppo Oncologico del Nord-Ovest 
Intervention: Panitumumab 
Start Date: 2017-09-13 
Last Updated: 2023-01-05 
Number of Patients: 435 
Recruitment Status: COMPLETED 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT02155647

Title: Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) 
Study Summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Avelumab 
Start Date: 2014-07-03 
Last Updated: 2023-06-05 
Number of Patients: 204 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Merkel Cell 

NCTID: NCT03225937

Title: Evaluation of Trastuzumab in Combination With Lapatinib or Pertuzumab in Combination With Trastuzumab-Emtansine to Treat Patients With HER2-positive Metastatic Colorectal Cancer 
Study Summary: This is a Phase II multi-center 2-sequential cohorts trial, designed to assess the objective response rate of two anti HER2 combination in advanced disease CRC patients harbouring an amplified HER2 tumor assessed according to HERACLES Diagnostic Criteria by FISH/SISH.  Cohort A: monoclonal antibody trastuzumab, used in combination with the small molecule tyrosine kinase inhibitor lapatinib.  Cohort B, monoclonal antibody pertuzumab, used in combination with the antibody drug conjugate trastuzumab-emtansine.  Please note that cohort A accrual has been closed and endpoint already reached. 
Sponsor: Fondazione del Piemonte per l’Oncologia 
Intervention: Trastuzumab, Lapatinib 
Start Date: 2012-08 
Last Updated: 2018-10-30 
Number of Patients: 54 
Recruitment Status: UNKNOWN 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT04737187

Title: Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer 
Study Summary: This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. 
Sponsor: Taiho Oncology, Inc. 
Intervention: Trifluridine/Tipiracil 
Start Date: 2020-11-25 
Last Updated: 2023-07-14 
Number of Patients: 490 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Refractory Metastatic Colorectal Cancer 

NCTID: NCT03860883

Title: Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma 
Study Summary: Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life. 
Sponsor: Melanoma and Skin Cancer Trials Limited 
Intervention: Wide Local Excision = 1cm Margin 
Start Date: 2019-12-17 
Last Updated: 2023-10-19 
Number of Patients: 2998 
Recruitment Status: RECRUITING 
Condition: Cutaneous Melanoma, Stage II 

NCTID: NCT01966471

Title: A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer 
Study Summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2014-01-31 
Last Updated: 2022-06-14 
Number of Patients: 1846 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04195750

Title: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) 
Study Summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2020-02-27 
Last Updated: 2022-08-01 
Number of Patients: 736 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT03840200

Title: A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer. 
Study Summary: This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide). 
Sponsor: Hoffmann-La Roche 
Intervention: Ipatasertib 
Start Date: 2019-06-12 
Last Updated: 2023-10-30 
Number of Patients: 51 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT03940703

Title: A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) 
Study Summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Tepotinib 
Start Date: 2019-09-19 
Last Updated: 2023-08-29 
Number of Patients: 120 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT06133465

Title: Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management 
Study Summary: The goal of this retrospective multicenter observational study is to understand and evaluate the diagnostic and therapeutic management of pure forms of Florid Lobular Carcinoma In Situ (FLCIS) and Pleomorphic Lobular Carcinoma In Situ (PLCIS) of the breast. It addresses the significant challenges and controversies surrounding their clinical management, due to a lack of consensus or approved international guidelines.  The main questions this study aims to answer are:  * How is the diagnostic process for pure FLCIS and PLCIS currently managed? * What are the primary therapeutic approaches for these specific breast conditions? * How are positive and “close” surgical excision margins handled? * Is adjuvant treatment, such as hormone therapy and radiotherapy, necessary? * What factors are associated with recurrences? * What are the rates of recurrences and/or upgrade to invasive carcinoma?  Participants will retrospectively collect all cases of pure FLCIS and PLCIS, reporting detailed data about their diagnostic and therapeutic management, as well as clinical and survival outcomes.  Methodology:  This international multicenter retrospective study will collect cases involving the pure forms of FLCIS and PLCIS of the breast. The study aims to provide insights into the current diagnostic and therapeutic approaches, along with the identification of opportunities to enhance clinical management, ultimately providing evidence-based recommendations and addressing the current lack of scientific literature regarding their treatment. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Surgical wide local excision 
Start Date: 2023-10-15 
Last Updated: 2023-11-18 
Number of Patients: 250 
Recruitment Status: RECRUITING 
Condition: Pleomorphic Lobular Breast Carcinoma in Situ 

NCTID: NCT05775289

Title: A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer 
Study Summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Tobemstomig 
Start Date: 2023-03-15 
Last Updated: 2023-11-02 
Number of Patients: 180 
Recruitment Status: RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT03783442

Title: A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC). 
Sponsor: BeiGene 
Intervention: Cisplatin 
Start Date: 2018-12-11 
Last Updated: 2023-11-07 
Number of Patients: 649 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Esophageal Squamous Cell Carcinoma (ESCC) 

NCTID: NCT05050942

Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET 
Study Summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. 
Sponsor: Camurus AB 
Intervention: CAM2029 
Start Date: 2021-10-22 
Last Updated: 2023-10-06 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Gastro-enteropancreatic Neuroendocrine Tumor 

NCTID: NCT03740165

Title: Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036) 
Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.  The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score <math display="block">CPS</math>≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-12-18 
Last Updated: 2023-09-08 
Number of Patients: 1367 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT02999672

Title: A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors 
Study Summary: This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced (unresectable and not treatable with curative intent) or metastatic urothelial bladder cancer (UBC), locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma with advanced disease where cure is no longer possible and where no other treatment options are available anymore. Participants will receive intravenous (IV) infusion of trastuzumab emtansine as Regimen A (2.4 milligrams per kilogram <math display="block">mg/kg</math>, weekly <math display="block">qw</math>) or Regimen B (3.6 mg/kg, every 3 weeks <math display="block">q3w</math>) until unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever occurs first. Based on tolerability and safety aspects, steering committee and Independent Data Monitoring Committee (iDMC) will decide on expansion of the study to include more participants with other carcinoma types. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2016-12-23 
Last Updated: 2019-08-28 
Number of Patients: 20 
Recruitment Status: COMPLETED 
Condition: Bladder Cancer 

NCTID: NCT01860638

Title: A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma 
Study Summary: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line <math display="block">2L</math> treatment) and SOC (in 3rd-line <math display="block">3L</math> and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant). 
Sponsor: Hoffmann-La Roche 
Intervention: Bevacizumab 
Start Date: 2013-08-19 
Last Updated: 2018-04-30 
Number of Patients: 296 
Recruitment Status: COMPLETED 
Condition: Glioblastoma 

NCTID: NCT01367665

Title: STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma 
Study Summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity. 
Sponsor: Hoffmann-La Roche 
Intervention: vismodegib 
Start Date: 2011-07-01 
Last Updated: 2019-06-06 
Number of Patients: 1232 
Recruitment Status: COMPLETED 
Condition: Basal Cell Carcinoma 

NCTID: NCT05062889

Title: Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients 
Study Summary: The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse. 
Sponsor: Gruppo Oncologico del Nord-Ovest 
Intervention: 5-Fluorouracil continuous infusion FOLFOXIRI schedule 
Start Date: 2023-05-17 
Last Updated: 2023-06-29 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Stage II Colon Cancer 

NCTID: NCT02291289

Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) 
Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. 
Sponsor: Hoffmann-La Roche 
Intervention: Cetuximab 
Start Date: 2015-04-17 
Last Updated: 2021-05-26 
Number of Patients: 609 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT02627963

Title: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) 
Study Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).  Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.  Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor <math display="block">programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor</math> plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).  All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.  Pharmacokinetic (PK) analyses are also included in study. 
Sponsor: AVEO Pharmaceuticals, Inc. 
Intervention: Tivozanib hydrochloride 
Start Date: 2016-05-24 
Last Updated: 2023-07-18 
Number of Patients: 350 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Renal Cell 

NCTID: NCT03456063

Title: A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030) 
Study Summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody 
Start Date: 2018-04-24 
Last Updated: 2023-10-27 
Number of Patients: 453 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Small-Cell Lung 

NCTID: NCT02347163

Title: Pre-operative Zoledronate in Triple Negative Breast Cancer 
Study Summary: Recent evidences suggest that zoledronate (zol), one of the most used bisphosphonates (BPs) in the clinical setting for the prevention and treatment of bone metastasis in cancer patients, may have antitumor activity in early breast cancer in terms of improved disease free survival, overall survival and better response in BPs treated patients. BPs are mevalonate pathway inhibitors and one of the most intriguing hypothesis supporting their anticancer activity relies on the modulation of the mevalonate downstream metabolism. Biologically active mevalonate metabolites are involved in tumour cell proliferation and invasion and selected cancer subtypes may present a more pronounced mevalonate activity, able of maintaining an aggressive phenotype. The mevalonate pathway has deep impact on the function of YAP/TAZ, transcriptional regulators of tumour growth, and preclinical evidences suggest that BPs are able to interfere with YAP/TAZ expression, via mevalonate pathway. This study addresses the clinical role of BPs in triple negative breast cancer (TNBC) patients selected by the level of mevalonate pathway regulation, namely the p53 expression. This study is a multicenter single-arm, phase II study primarily aimed at assessing the anti-tumor activity of pre-operative zol measured through its effect on the Ki67 proliferative biomarker, in TNBC patients classified according to the p53 expression (high vs low p53 expression). Patients with newly diagnosed, untreated, operable TNBC, intended to definitive breast surgery and suitable for pre-operative therapy with zoledronate will receive a pre-operative, single administration of zol (4mg i.v.), 7 days before definitive breast surgery. Ki67 levels will be assessed in tumor samples collected at the time of diagnosis and after zoledronate treatment at the time of definitive surgery. The secondary objective of the study is to investigate the effect of zoledronate on critical genes/proteins related to p53 and mevalonate pathways, p53/PIN1 and YAP/TAZ, analyzed in the tumor tissue collected at the time of diagnosis and at definitive surgery. Zol safety profile will be evaluated by the NCI-CTCAE scale, version 4.0, and by the occurrence of serious adverse reactions. The total number of patients required is forty. The overall duration of the project is 32 months (30 months for accrual, followed by 2 months of follow-up after the recruitment of the last patient). 
Sponsor: Mario Negri Institute for Pharmacological Research 
Intervention: Zoledronate 
Start Date: 2015-02-03 
Last Updated: 2018-11-06 
Number of Patients: 22 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT03235245

Title: Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib 
Study Summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Nivolumab + Ipilimumab 
Start Date: 2018-10-30 
Last Updated: 2023-11-03 
Number of Patients: 271 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Unresectable Stage III Melanoma 

NCTID: NCT01752920

Title: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations 
Study Summary: This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding). 
Sponsor: Basilea Pharmaceutica 
Intervention: Derazantinib low dose range 
Start Date: 2012-12-10 
Last Updated: 2023-06-05 
Number of Patients: 119 
Recruitment Status: COMPLETED 
Condition: Solid Tumor 

NCTID: NCT01738620

Title: Quality of Life After Esophagectomy for Cancer - Step 1 
Study Summary: Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.  The study is divided into two steps.  This is step 1.  Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI. 
Sponsor: University of Padova 
Intervention: psychological counseling 
Start Date: 2013-01 
Last Updated: 2017-04-12 
Number of Patients: 74 
Recruitment Status: TERMINATED 
Condition: Esophageal Cancer 

NCTID: NCT01853826

Title: An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s) 
Study Summary: To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI 
Sponsor: Boehringer Ingelheim 
Intervention: afatinib 
Start Date: 2013-07-17 
Last Updated: 2023-07-12 
Number of Patients: 481 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT01913652

Title: Ph II Cabazitaxel DD Liposarcoma 
Study Summary: Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Cabazitaxel 
Start Date: 2014-10 
Last Updated: 2021-09-14 
Number of Patients: 42 
Recruitment Status: COMPLETED 
Condition: Dedifferentiated Liposarcoma 

NCTID: NCT02715804

Title: A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma 
Study Summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). 
Sponsor: Halozyme Therapeutics 
Intervention: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) 
Start Date: 2016-03-14 
Last Updated: 2020-07-14 
Number of Patients: 492 
Recruitment Status: TERMINATED 
Condition: Pancreatic Ductal Carcinoma 

NCTID: NCT04543617

Title: A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C). 
Sponsor: Hoffmann-La Roche 
Intervention: Tiragolumab 
Start Date: 2020-09-28 
Last Updated: 2023-11-03 
Number of Patients: 760 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Esophageal Squamous Cell Carcinoma 

NCTID: NCT04624204

Title: Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) 
Study Summary: The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).  Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.  Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.  Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.  Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 200 mg 
Start Date: 2020-12-08 
Last Updated: 2023-11-28 
Number of Patients: 672 
Recruitment Status: RECRUITING 
Condition: Small Cell Lung Cancer 

NCTID: NCT03944252

Title: Cetuximab + Avelumab or Avelumab Alone for Unresectable, Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (SCCAC) Progressed After at Least One Line of Systemic Treatment (CARACAS) 
Study Summary: * The standard first line treatment in SCCAC is the association of 5-FU with cisplatin reaching a percentage of survival at 5 years of about 32% (Faivre 1999); in a recent case series of patients affected by SCCAC, the combination of 5-FU and cisplatin as first line treatment produced 34.4% objective response rate (ORR) and a 5 years survival rate of 15% (Sclafani 2017); * No standard second line treatment exists for SCCAC; * Cetuximab in association with irinotecan has demonstrated promising results in pretreated patients affected by SCCAC (Lukan 2009). In addition, it was recently tested in stage I-III SCCAC in association with cisplatin plus 5-FU and radiotherapy. Despite not reaching their pre-specified endpoints both studies reported an interesting activity in local control of disease, leading to hypothesize that cetuximab warrant further investigation in new strategies (Garg 2017, Sparano 2017); * Anti-PD1 treatments such as nivolumab and pembrolizumab showed promising activity in metastatic refractory SCCAC in terms of response rate and disease control with acceptable toxicity profiles (Morris 2017, Ott 2017); * The induction of immunogenic cell death was recently shown for cetuximab-based regimens (Pozzi 2016) and PD-L1 blockade should lead to NK cells activation enhancing cetuximab ADCC (Concha-Benavente 2015, Concha-Benavente 2016).  On the basis of these considerations, the investigators designed the present randomized phase II trial of avelumab alone or avelumab plus cetuximab for previously treated unresectable locally advanced or metastatic SCCAC. 
Sponsor: Gruppo Oncologico del Nord-Ovest 
Intervention: Avelumab 
Start Date: 2018-09-18 
Last Updated: 2019-07-26 
Number of Patients: 54 
Recruitment Status: UNKNOWN 
Condition: Squamous Cell Anal Carcinoma 

NCTID: NCT04464226

Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer 
Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. 
Sponsor: Bayer 
Intervention: Darolutamide (Nubeqa, BAY1841788) 
Start Date: 2020-10-20 
Last Updated: 2023-11-18 
Number of Patients: 678 
Recruitment Status: RECRUITING 
Condition: Cancer 

NCTID: NCT03434379

Title: A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma 
Study Summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2018-03-15 
Last Updated: 2023-10-23 
Number of Patients: 558 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Hepatocellular 

NCTID: NCT04177108

Title: A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer. 
Study Summary: This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2019-11-25 
Last Updated: 2023-03-23 
Number of Patients: 242 
Recruitment Status: COMPLETED 
Condition: Triple-Negative Breast Cancer 

NCTID: NCT03994627

Title: Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma 
Study Summary: The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS). 
Sponsor: Eli Lilly and Company 
Intervention: Olaratumab 
Start Date: NA 
Last Updated: 2023-09-29 
Number of Patients: NA 
Recruitment Status: AVAILABLE 
Condition: Soft Tissue Sarcoma 

NCTID: NCT04677504

Title: A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer 
Study Summary: This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2021-02-23 
Last Updated: 2023-10-10 
Number of Patients: 162 
Recruitment Status: COMPLETED 
Condition: Biliary Tract Cancer 

NCTID: NCT02008227

Title: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy 
Study Summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2014-03-11 
Last Updated: 2019-12-20 
Number of Patients: 1225 
Recruitment Status: COMPLETED 
Condition: Non-Squamous Non-Small Cell Lung Cancer 

NCTID: NCT03371017

Title: A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer 
Study Summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC). 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2018-01-11 
Last Updated: 2023-11-07 
Number of Patients: 572 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Triple Negative Breast Neoplasms 

NCTID: NCT03227926

Title: Rechallenge With Panitumumab Driven by RAS Dynamic of Resistance 
Study Summary: This is a hypothesis driven, open label, single-arm, multiple centers, Phase II trial. The trial has been designed to prove or disprove whether a rechallenge with panitumumab can achieve an objective response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients selected on the basis of RAS extended clonal evolution in their plasma. 
Sponsor: Fondazione del Piemonte per l’Oncologia 
Intervention: Panitumumab 20 MG/ML Intravenous Solution [VECTIBIX] 
Start Date: 2017-10-11 
Last Updated: 2022-08-25 
Number of Patients: 32 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT05111626

Title: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer 
Study Summary: The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.  The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival. 
Sponsor: Amgen 
Intervention: Bemarituzumab 
Start Date: 2022-03-14 
Last Updated: 2023-11-27 
Number of Patients: 528 
Recruitment Status: RECRUITING 
Condition: Gastric Cancer 

NCTID: NCT03221426

Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) 
Study Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.  The primary study hypotheses are that:  * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2017-10-09 
Last Updated: 2023-09-22 
Number of Patients: 1007 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Gastric Cancer 

NCTID: NCT04546009

Title: A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) 
Study Summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer. 
Sponsor: Hoffmann-La Roche 
Intervention: Giredestrant 
Start Date: 2020-10-09 
Last Updated: 2023-11-18 
Number of Patients: 992 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer 

NCTID: NCT03763604

Title: Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer 
Study Summary: The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program. 
Sponsor: Eli Lilly and Company 
Intervention: Abemaciclib 
Start Date: NA 
Last Updated: 2023-10-12 
Number of Patients: NA 
Recruitment Status: AVAILABLE 
Condition: Metastatic Breast Cancer 

NCTID: NCT04227327

Title: Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7) 
Study Summary: The HERMIONE-7 trial is a phase II, single-arm, open-label, multicenter study in HR+, HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease. Patients will receive aromatase inhibitors plus Abemaciclib. 
Sponsor: University of Milano Bicocca 
Intervention: Abemaciclib 
Start Date: 2020-01-07 
Last Updated: 2023-04-13 
Number of Patients: 31 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced Breast Cancer 

NCTID: NCT04066491

Title: Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC 
Study Summary: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: M7824 
Start Date: 2019-09-20 
Last Updated: 2023-11-14 
Number of Patients: 309 
Recruitment Status: TERMINATED 
Condition: Biliary Tract Cancer 

NCTID: NCT04657991

Title: A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma 
Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment.  All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day.  Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. 
Sponsor: Pfizer 
Intervention: Encorafenib 
Start Date: 2021-01-15 
Last Updated: 2023-11-07 
Number of Patients: 624 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT03556839

Title: Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix 
Study Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.  The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).  This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment. 
Sponsor: Grupo Español de Investigación en Cáncer de Ovario 
Intervention: Atezolizumab 
Start Date: 2018-09-25 
Last Updated: 2023-09-13 
Number of Patients: 404 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma of the Cervix, Stage IVB 

NCTID: NCT00878709

Title: Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer 
Study Summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab. 
Sponsor: Puma Biotechnology, Inc. 
Intervention: neratinib 
Start Date: 2009-07-09 
Last Updated: 2021-06-11 
Number of Patients: 2840 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02928406

Title: A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract 
Study Summary: This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2016-11-30 
Last Updated: 2022-12-22 
Number of Patients: 1005 
Recruitment Status: COMPLETED 
Condition: Urinary Tract Cancer 

NCTID: NCT04031339

Title: Study of Clinical Outcomes of Thyroid Cancer 
Study Summary: The Italian Thyroid Cancer Observatory (ITCO) repository was established to collect data on thyroid cancer management in a prospective and consecutive series of newly-diagnosed patients, enrolled in centers uniformly distributed across the nation. 
Sponsor: University of Roma La Sapienza 
Intervention: Standard treatment 
Start Date: 2013-01-01 
Last Updated: 2023-05-10 
Number of Patients: 15000 
Recruitment Status: RECRUITING 
Condition: Thyroid Neoplasms 

NCTID: NCT03726879

Title: A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer 
Study Summary: This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0). 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2019-01-11 
Last Updated: 2023-09-25 
Number of Patients: 454 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05153239

Title: Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON) 
Study Summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator’s Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line. 
Sponsor: PharmaMar 
Intervention: Irinotecan 
Start Date: 2022-07-22 
Last Updated: 2023-11-27 
Number of Patients: 705 
Recruitment Status: RECRUITING 
Condition: Relapsed Small Cell Lung Cancer 

NCTID: NCT02724020

Title: MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy. 
Sponsor: Millennium Pharmaceuticals, Inc. 
Intervention: Everolimus 
Start Date: 2016-06-30 
Last Updated: 2021-11-19 
Number of Patients: 96 
Recruitment Status: COMPLETED 
Condition: Clear-cell Metastatic Renal Cell Carcinoma 

NCTID: NCT04194775

Title: A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma 
Study Summary: This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product of and lenvatinib is selected as the basic treatment for HCC. 
Sponsor: CStone Pharmaceuticals 
Intervention: Nofazinlimab (CS1003)+Lenvatinib 
Start Date: 2019-12-13 
Last Updated: 2023-07-10 
Number of Patients: 534 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hepatocellular Carcinoma 

NCTID: NCT04785820

Title: A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus 
Study Summary: This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen.  Following approval of the protocol amendment version 3, recruitment into the lomvastomig arm has been stopped. The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for lomvastomig remains unchanged.  The study was planned to enroll participants randomized in a 1:1:1 ratio to receive lomvastomig, tobemstomig, or nivolumab. With version 3 of the protocol, recruitment into the lomvastomig arm has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either tobemstomig or nivolumab. 
Sponsor: Hoffmann-La Roche 
Intervention: Lomvastomig 
Start Date: 2021-06-25 
Last Updated: 2023-09-08 
Number of Patients: 210 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced or Metastatic Esophageal Squamous Cell Carcinoma 

NCTID: NCT02234050

Title: Trabectedin for Recurrent Grade II/III Meningioma 
Study Summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Trabectedin 
Start Date: 2015-07 
Last Updated: 2019-02-28 
Number of Patients: 90 
Recruitment Status: COMPLETED 
Condition: Recurrent High Grade Meningioma 

NCTID: NCT05794906

Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies 
Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.  BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.  In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.  The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.  To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.  To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.  During the study, the study team will:  * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems  About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. 
Sponsor: Bayer 
Intervention: Darolutamide (BAY1841788, Nubeqa) 
Start Date: 2023-04-03 
Last Updated: 2023-11-28 
Number of Patients: 750 
Recruitment Status: RECRUITING 
Condition: Biochemically Recurrent Prostate Cancer 

NCTID: NCT02436668

Title: Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE) 
Study Summary: This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma. 
Sponsor: Pharmacyclics LLC. 
Intervention: Ibrutinib 
Start Date: 2015-05 
Last Updated: 2020-12-30 
Number of Patients: 430 
Recruitment Status: COMPLETED 
Condition: Metastatic Pancreatic Adenocarcinoma 

NCTID: NCT05386550

Title: Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) 
Study Summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Xevinapant (Debio 1143) 
Start Date: 2022-10-06 
Last Updated: 2023-11-02 
Number of Patients: 700 
Recruitment Status: RECRUITING 
Condition: Head and Neck Cancer 

NCTID: NCT04480268

Title: PAXG Out in the Country 
Study Summary: The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center. 
Sponsor: IRCCS San Raffaele 
Intervention: PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy 
Start Date: 2020-07-08 
Last Updated: 2021-02-10 
Number of Patients: 175 
Recruitment Status: RECRUITING 
Condition: Pancreatic Ductal Adenocarcinoma 

NCTID: NCT04072068

Title: Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy 
Study Summary: This is a multicentric, phase IV study. In this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. Edoxaban will be administered according to summary of product characteristics. Patients will receive 6 to 12 months of treatment with edoxaban administered orally. The thromboembolic event will be monitored as per local clinical practice. In this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). During these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires. 
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica 
Intervention: Edoxaban 
Start Date: 2019-06-27 
Last Updated: 2023-05-30 
Number of Patients: 150 
Recruitment Status: COMPLETED 
Condition: Thromboembolism 

NCTID: NCT04487067

Title: A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista 
Study Summary: This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2020-08-25 
Last Updated: 2023-11-21 
Number of Patients: 152 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Hepatocellular 

NCTID: NCT04603807

Title: A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases 
Study Summary: The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Entrectinib 
Start Date: 2021-09-30 
Last Updated: 2023-11-29 
Number of Patients: 220 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT02568267

Title: Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) 
Study Summary: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion. 
Sponsor: Hoffmann-La Roche 
Intervention: Entrectinib 
Start Date: 2015-11-19 
Last Updated: 2023-10-06 
Number of Patients: 534 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01307397

Title: A Study of Vemurafenib in Participants With Metastatic Melanoma 
Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Vemurafenib 
Start Date: 2011-03-01 
Last Updated: 2017-12-18 
Number of Patients: 3219 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT03148795

Title: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer 
Study Summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone). 
Sponsor: Pfizer 
Intervention: Talazoparib 
Start Date: 2017-07-04 
Last Updated: 2023-05-10 
Number of Patients: 128 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT04163900

Title: Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer 
Study Summary: NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.  The primary hypotheses are:  * The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care * The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care 
Sponsor: NuCana plc 
Intervention: NUC-1031 
Start Date: 2019-12-24 
Last Updated: 2023-05-24 
Number of Patients: 773 
Recruitment Status: TERMINATED 
Condition: Biliary Tract Cancer 

NCTID: NCT05630937

Title: Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy 
Study Summary: This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy.  The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment.  The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate. 
Sponsor: Nerviano Medical Sciences 
Intervention: NMS-01940153E 
Start Date: 2020-11-13 
Last Updated: 2023-11-18 
Number of Patients: 57 
Recruitment Status: RECRUITING 
Condition: Unresectable Hepatocellular Carcinoma (HCC) 

NCTID: NCT03452137

Title: A Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck 
Study Summary: This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN) 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2018-04-03 
Last Updated: 2023-09-18 
Number of Patients: 406 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) 

NCTID: NCT02499614

Title: Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS) 
Study Summary: Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1 translocation or MET amplification or MET exon 14 mutation 
Sponsor: Fondazione Ricerca Traslazionale 
Intervention: Crizotinib 
Start Date: 2014-12 
Last Updated: 2017-10-25 
Number of Patients: 80 
Recruitment Status: UNKNOWN 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT03038100

Title: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer 
Study Summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery. 
Sponsor: Hoffmann-La Roche 
Intervention: Paclitaxel 
Start Date: 2017-03-08 
Last Updated: 2023-02-17 
Number of Patients: 1301 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT04696055

Title: Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors 
Study Summary: Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.  In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.  There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.  During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase. 
Sponsor: Bayer 
Intervention: Pembrolizumab 
Start Date: 2021-02-03 
Last Updated: 2023-11-18 
Number of Patients: 95 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hepatocellular Carcinoma 

NCTID: NCT02576431

Title: A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors 
Study Summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. 
Sponsor: Bayer 
Intervention: BAY2757556 (Larotrectinib, Vitrakvi) 
Start Date: 2015-09-30 
Last Updated: 2023-11-07 
Number of Patients: 204 
Recruitment Status: RECRUITING 
Condition: Solid Tumors Harboring NTRK Fusion 

NCTID: NCT01896531

Title: A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer 
Study Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 <math display="block">mFOLFOX6</math>) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle. 
Sponsor: Genentech, Inc. 
Intervention: 5-Fluorouracil 
Start Date: 2013-08-14 
Last Updated: 2022-03-02 
Number of Patients: 153 
Recruitment Status: COMPLETED 
Condition: Gastric Cancer 

NCTID: NCT03869892

Title: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. 
Study Summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab. 
Sponsor: Institut de Recherches Internationales Servier 
Intervention: Trifluridine/tipiracil hydrochloride (S95005) 
Start Date: 2019-03-21 
Last Updated: 2023-11-18 
Number of Patients: 856 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT05327530

Title: A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) 
Study Summary: The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Avelumab 
Start Date: 2022-08-17 
Last Updated: 2023-10-23 
Number of Patients: 252 
Recruitment Status: RECRUITING 
Condition: Locally Advanced or Metastatic Urothelial Carcinoma 

NCTID: NCT05253651

Title: A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer 
Study Summary: This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.  Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).  Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:  * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer. 
Sponsor: Seagen Inc. 
Intervention: tucatinib 
Start Date: 2022-10-24 
Last Updated: 2023-11-29 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Colorectal Neoplasms 

NCTID: NCT01767155

Title: Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer 
Study Summary: Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. 
Sponsor: AEterna Zentaris 
Intervention: AEZS-108 / zoptarelin doxorubicin 
Start Date: 2013-04 
Last Updated: 2018-07-31 
Number of Patients: 511 
Recruitment Status: COMPLETED 
Condition: Endometrial Cancer 

NCTID: NCT03016312

Title: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen 
Study Summary: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2017-01-10 
Last Updated: 2023-02-17 
Number of Patients: 772 
Recruitment Status: COMPLETED 
Condition: Prostatic Neoplasms, Castration-Resistant 

NCTID: NCT05288166

Title: A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) 
Study Summary: The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months. 
Sponsor: Eli Lilly and Company 
Intervention: Abemaciclib 
Start Date: 2022-04-14 
Last Updated: 2023-10-19 
Number of Patients: 900 
Recruitment Status: RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT01667419

Title: A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma 
Study Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than <math display="block">\></math> 1 millimeter <math display="block">mm</math> in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period. 
Sponsor: Hoffmann-La Roche 
Intervention: Vemurafenib 
Start Date: 2012-09-24 
Last Updated: 2019-07-23 
Number of Patients: 498 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT05645692

Title: A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer 
Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2023-04-13 
Last Updated: 2023-11-07 
Number of Patients: 240 
Recruitment Status: RECRUITING 
Condition: Urothelial Cancer 

NCTID: NCT04573192

Title: A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression 
Study Summary: Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed.  L19TNF is a fully human fusion protein consisting of human tumor necrosis factor (TNF)-α fused to the L19 antibody in scFv format, specific to the extra-domain B of fibronectin. TNF not only induces apoptosis or necrosis in certain target cells, but also exerts inflammation and immunity. L19TNF selectively delivers TNF to the tumor site to spare normal tissues from undesired toxicity. Preclinical experiments with L19TNF have demonstrated tumor growth retardation in various mouse tumor models including models of glioma. 
Sponsor: Philogen S.p.A. 
Intervention: L19TNF 
Start Date: 2021-02-19 
Last Updated: 2023-11-22 
Number of Patients: 142 
Recruitment Status: RECRUITING 
Condition: Glioblastoma 

NCTID: NCT04597125

Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH 
Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.  Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. 
Sponsor: Bayer 
Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) 
Start Date: 2020-11-09 
Last Updated: 2023-11-14 
Number of Patients: 696 
Recruitment Status: RECRUITING 
Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC) 

NCTID: NCT04256421

Title: A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer 
Study Summary: This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (</= upper limit of normal <math display="block">ULN</math> vs. > ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:  * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE  Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B). 
Sponsor: Hoffmann-La Roche 
Intervention: Tiragolumab 
Start Date: 2020-02-04 
Last Updated: 2023-11-07 
Number of Patients: 490 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Small Cell Lung Cancer 

NCTID: NCT04607421

Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer 
Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that:  * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment.  Participants in this study will receive one of the following study treatments:  * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home.  The study team will monitor how each participant responds to the study treatment for up to about 3 years. 
Sponsor: Pfizer 
Intervention: Encorafenib 
Start Date: 2020-12-21 
Last Updated: 2023-09-11 
Number of Patients: 815 
Recruitment Status: RECRUITING 
Condition: Neoplasms 

NCTID: NCT01597414

Title: Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1 
Study Summary: Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.  The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Pertuzumab + trastuzumab 
Start Date: 2013-06 
Last Updated: 2022-11-17 
Number of Patients: 80 
Recruitment Status: COMPLETED 
Condition: Elderly Metastatic Breast Cancer Population 

NCTID: NCT03498521

Title: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site 
Study Summary: This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Alectinib 
Start Date: 2018-07-10 
Last Updated: 2023-11-18 
Number of Patients: 790 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cancer of Unknown Primary Site 

NCTID: NCT02904031

Title: Study of I Line FOLFOX + Panitumumab vs 5FU + Panitumumab in RAS and BRAF WT Metastatic Colorectal Cancer Elderly Patients 
Study Summary: * Few data are available about the treatment of metastatic colorectal cancer (mCRC) elderly patients with anti-EGFR agents in combination with chemotherapy. Up today, most of the available data are from retrospective/post-hoc analyses, making them difficult to translate to everyday clinical practice. * FOLFOX plus panitumumab is a standard first-line therapy option for RAS wild-type untreated mCRC patients. Slight adjustments in chemo-dosage are commonly applied in routinary practice to elderly patients, but those modified schedules have never been prospectively tested. * In elderly patients, a reasonable upfront treatment is a fluoropyrimidine-based monotherapy plus bevacizumab, irrespectively of the molecular status of RAS. * BRAF mutation is a strong negative prognostic factor associated to advanced age, poor performance status (PS), extended and aggressive disease and is associated to a lack of benefit from anti-EGFR moAb. * Clinical definition of elderly (over 70 years old) CRC patients that may deserve a more or less intensive combination therapy is still debated. The cut-off of 75 years old combined with ECOG PS assessment is a reasonable approach for clearly defining candidates to different approaches31. * Several geriatric screening tools have been used to identify patients with a geriatric profile potentially predicting for overall survival and risk of toxicity. The G8 screening tool has been validated in cancer patients showing the strongest prognostic value for overall survival; the CRASH score is able to stratify patients according an estimated risk of treatment-related toxicities.  On the basis of these considerations, the investigators designed the present randomized phase II trial of first-line therapy panitumumab in combination with simplified FOLFOX or with 5-fluorouracil, in previously untreated elderly patients with RAS and BRAF wild-type unresectable mCRC. 
Sponsor: Gruppo Oncologico del Nord-Ovest 
Intervention: 5-fluorouracil 
Start Date: 2016-07 
Last Updated: 2020-05-12 
Number of Patients: 180 
Recruitment Status: UNKNOWN 
Condition: Elderly Metastatic Colorectal Cancer Patients 

NCTID: NCT02293785

Title: GREAT - Good Response With Appropriate Treatment 
Study Summary: The symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. The pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic.  The use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist.  Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone. 
Sponsor: Mario Negri Institute for Pharmacological Research 
Intervention: Oxycodone-Naloxone 
Start Date: 2014-11 
Last Updated: 2016-03-21 
Number of Patients: 200 
Recruitment Status: COMPLETED 
Condition: Cancer Pain 

NCTID: NCT03523585

Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] 
Study Summary: This study will compare DS 8201a to standard treatment.  Participants must have HER2 breast cancer that has been treated before.  Their cancer:  * cannot be removed by an operation * has spread to other parts of the body 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: Trastuzumab deruxtecan 
Start Date: 2018-08-01 
Last Updated: 2023-06-26 
Number of Patients: 608 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05675085

Title: Risk-Based Breast Screening in Young Women 
Study Summary: The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial).  Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening.  The only primary endpoint in this study is the cumulative incidence of advanced breast cancers (stage II and above). This endpoint will be evaluated at the end of the five-year intervention period and at 10 years.  The results of the personalized screening model will be compared with those obtained from an observational cohort from a neighboring region in which a “one-size-fits-all” approach involving annual mammography for women aged 45-49 years is used. The comparison will be conducted with the hypothesis of superiority of the personalized screening model. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Personalized screening protocol 
Start Date: 2020-01-20 
Last Updated: 2023-10-12 
Number of Patients: 10269 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT00507429

Title: Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer 
Study Summary: The purpose of the study is to determine the safety and efficacy of combretastatin combined with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC). 
Sponsor: Mateon Therapeutics 
Intervention: CA4P 
Start Date: 2007-08 
Last Updated: 2014-06-09 
Number of Patients: 80 
Recruitment Status: TERMINATED 
Condition: Anaplastic Thyroid Cancer 

NCTID: NCT02083653

Title: Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer 
Study Summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs). 
Sponsor: Symphogen A/S 
Intervention: Sym004 (12 mg/kg) 
Start Date: 2014-03-06 
Last Updated: 2019-04-16 
Number of Patients: 254 
Recruitment Status: COMPLETED 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT02625610

Title: Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) 
Study Summary: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Avelumab 
Start Date: 2015-12-24 
Last Updated: 2022-06-09 
Number of Patients: 499 
Recruitment Status: COMPLETED 
Condition: Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction 

NCTID: NCT02994953

Title: A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12) 
Study Summary: The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Avelumab 
Start Date: 2017-01-31 
Last Updated: 2020-12-17 
Number of Patients: 52 
Recruitment Status: TERMINATED 
Condition: Advanced Solid Tumors 

NCTID: NCT03273153

Title: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma 
Study Summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Cobimetinib 
Start Date: 2017-12-11 
Last Updated: 2022-09-21 
Number of Patients: 446 
Recruitment Status: TERMINATED 
Condition: Advanced BRAFV600 Wild-type Melanoma 

NCTID: NCT04393753

Title: Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 
Study Summary: This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody 
Sponsor: 4SC AG 
Intervention: domatinostat in combination with avelumab 
Start Date: 2020-09-01 
Last Updated: 2023-07-13 
Number of Patients: 19 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Merkel Cell Carcinoma 

NCTID: NCT04031677

Title: Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma 
Study Summary: This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.  After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Surgery 
Start Date: 2021-01-20 
Last Updated: 2023-10-27 
Number of Patients: 250 
Recruitment Status: RECRUITING 
Condition: Retroperitoneal Sarcoma 

NCTID: NCT05330429

Title: Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) 
Study Summary: The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).  The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). 
Sponsor: Gilead Sciences 
Intervention: Magrolimab 
Start Date: 2022-07-08 
Last Updated: 2023-11-02 
Number of Patients: 135 
Recruitment Status: RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT02904577

Title: Indolent Non Follicular Lymphomas Prognostic Project 
Study Summary: Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: Any treatment, watch and wait policy included 
Start Date: 2011-09 
Last Updated: 2023-09-14 
Number of Patients: 370 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Indolent B-Cell Lymphomas 

NCTID: NCT04634877

Title: Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) 
Study Summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-01-10 
Last Updated: 2023-11-21 
Number of Patients: 990 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Endometrial Neoplasms 

NCTID: NCT04294810

Title: A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer 
Study Summary: The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2020-03-04 
Last Updated: 2023-11-03 
Number of Patients: 620 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT04873362

Title: A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy 
Study Summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2021-05-04 
Last Updated: 2023-11-13 
Number of Patients: 1700 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT03024996

Title: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy 
Study Summary: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2017-01-03 
Last Updated: 2023-08-03 
Number of Patients: 778 
Recruitment Status: TERMINATED 
Condition: Renal Cell Carcinoma 

NCTID: NCT04764188

Title: An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib 
Study Summary: This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice. 
Sponsor: Hoffmann-La Roche 
Intervention: Alectinib 
Start Date: 2021-05-10 
Last Updated: 2023-11-08 
Number of Patients: 800 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: NSCLC 

NCTID: NCT04625023

Title: A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer 
Study Summary: METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology.  METAMECH will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, METAMECH will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials. 
Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology 
Intervention: Observational 
Start Date: 2020-07-16 
Last Updated: 2023-09-28 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02390869

Title: Rituximab and Lenalidomide vs Rituximab Alone as Maintenance After R-chemoterapy for Relapsed/Refractory FL Patients 
Study Summary: A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-chemotherapy (R-CHT) for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT) 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: R2-MANT 
Start Date: 2014-05 
Last Updated: 2023-09-13 
Number of Patients: 128 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Lymphoma, Follicular 

NCTID: NCT04515394

Title: Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE) 
Study Summary: The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Tepotinib 
Start Date: 2021-01-28 
Last Updated: 2022-12-22 
Number of Patients: 3 
Recruitment Status: TERMINATED 
Condition: Colorectal Neoplasms 

NCTID: NCT04604132

Title: Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma 
Study Summary: The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA). 
Sponsor: Basilea Pharmaceutica 
Intervention: Derazantinib 
Start Date: 2020-10-06 
Last Updated: 2023-02-16 
Number of Patients: 47 
Recruitment Status: TERMINATED 
Condition: Gastric Adenocarcinoma 

NCTID: NCT04656262

Title: Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients 
Study Summary: To compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Cyclophosphamide 
Start Date: 2018-09-10 
Last Updated: 2022-04-01 
Number of Patients: 132 
Recruitment Status: RECRUITING 
Condition: Soft Tissue Sarcoma Adult 

NCTID: NCT01772472

Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) 
Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. 
Sponsor: Hoffmann-La Roche 
Intervention: trastuzumab 
Start Date: 2013-04-03 
Last Updated: 2023-11-13 
Number of Patients: 1487 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05619172

Title: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer 
Study Summary: The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer. 
Sponsor: SOTIO Biotech AG 
Intervention: Nanrilkefusp alfa 
Start Date: 2022-12-22 
Last Updated: 2023-09-18 
Number of Patients: 52 
Recruitment Status: RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT02864992

Title: Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) 
Study Summary: This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Tepotinib 
Start Date: 2016-09-13 
Last Updated: 2023-06-09 
Number of Patients: 337 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification 

NCTID: NCT02402712

Title: Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer 
Study Summary: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400. 
Sponsor: Hoffmann-La Roche 
Intervention: Docetaxel 
Start Date: 2015-05-06 
Last Updated: 2019-09-06 
Number of Patients: 418 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05217446

Title: A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer 
Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that:  * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called “BRAF” and; * has not received prior treatment.  All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic.  In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic.  The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. 
Sponsor: Pfizer 
Intervention: Encorafenib 
Start Date: 2022-07-11 
Last Updated: 2023-10-25 
Number of Patients: 104 
Recruitment Status: RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT05601700

Title: Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) 
Study Summary: This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO).  The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2. 
Sponsor: Ente Ospedaliero Ospedali Galliera 
Intervention: Letrozole tablets 
Start Date: 2022-09-22 
Last Updated: 2023-06-29 
Number of Patients: 132 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Ovarian Epithelial 

NCTID: NCT04658862

Title: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder 
Study Summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Cetrelimab 
Start Date: 2020-12-07 
Last Updated: 2023-11-07 
Number of Patients: 550 
Recruitment Status: RECRUITING 
Condition: Urinary Bladder Neoplasms 

NCTID: NCT04222972

Title: A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) 
Study Summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib. 
Sponsor: Hoffmann-La Roche 
Intervention: Pralsetinib 
Start Date: 2020-07-24 
Last Updated: 2023-11-13 
Number of Patients: 226 
Recruitment Status: RECRUITING 
Condition: RET-fusion Non Small Cell Lung Cancer 

NCTID: NCT04895358

Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) 
Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.  The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: pembrolizumab 
Start Date: 2021-06-18 
Last Updated: 2023-11-27 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT02807636

Title: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma 
Study Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2016-06-30 
Last Updated: 2023-06-09 
Number of Patients: 1213 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urothelial Carcinoma 

NCTID: NCT03625141

Title: A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases 
Study Summary: This study will evaluate the efficacy and safety of cobimetinib plus atezolizumab in participants with BRAFV600 wild-type melanoma with central nervous system (CNS) metastases and of cobimetinib plus atezolizumab and vemurafenib in BRAFV600 mutation-positive melanoma patients with CNS metastases. 
Sponsor: Hoffmann-La Roche 
Intervention: Cobimetinib 
Start Date: 2018-12-13 
Last Updated: 2022-06-02 
Number of Patients: 80 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Melanoma 

NCTID: NCT00372996

Title: Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer 
Study Summary: To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer 
Sponsor: Pfizer 
Intervention: CP-751,871 
Start Date: 2007-02 
Last Updated: 2015-10-28 
Number of Patients: 219 
Recruitment Status: TERMINATED 
Condition: Breast Neoplasms 

NCTID: NCT02926196

Title: Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab 
Study Summary: Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients:  * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: MSB0010718C 
Start Date: 2016-06-17 
Last Updated: 2023-10-31 
Number of Patients: 474 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Triple Negative Breast Neoplasms 

NCTID: NCT02938299

Title: Neoadjuvant L19IL2/L19TNF- Pivotal Study 
Study Summary: Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients. 
Sponsor: Philogen S.p.A. 
Intervention: L19IL2 + L19TNF 
Start Date: 2016-07-01 
Last Updated: 2023-10-10 
Number of Patients: 214 
Recruitment Status: RECRUITING 
Condition: Malignant Melanoma 

NCTID: NCT04305041

Title: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) 
Study Summary: Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.  The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.  As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2020-06-26 
Last Updated: 2023-11-09 
Number of Patients: 200 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT03306394

Title: A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). 
Study Summary: The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).  Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor’s prescription or can be accessed from another source or Sponsor decision. 
Sponsor: Institut de Recherches Internationales Servier 
Intervention: Trifluridine/Tipiracil hydrochloride (S95005) 
Start Date: 2016-10-18 
Last Updated: 2021-11-17 
Number of Patients: 907 
Recruitment Status: COMPLETED 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT04793932

Title: Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL) 
Study Summary: The main aim of this study is to compare the efficacy of short-course versus long-course pre-operative chemotherapy with PAXG or mFOLFIRINOX in patients who receive a diagnosis of pancreatic ductal adenocarcinoma (PDAC) resectable or borderline resectable. 
Sponsor: Associazione Italiana per lo Studio del Pancreas 
Intervention: PAXG 
Start Date: 2020-11-03 
Last Updated: 2021-03-11 
Number of Patients: 261 
Recruitment Status: UNKNOWN 
Condition: Pancreas Ductal Adenocarcinoma 

NCTID: NCT03148418

Title: A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A) 
Study Summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2017-09-20 
Last Updated: 2023-11-18 
Number of Patients: 382 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cancer 

NCTID: NCT04700072

Title: Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02) 
Study Summary: Substudy 02D is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.  The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.  As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-05-03 
Last Updated: 2023-10-12 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT05582538

Title: Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab 

ab-Paclitaxel

Study Summary: This study will evaluate the efficacy and safety of ceralasertib followed by durvalumab plus nab-paclitaxel in 37 patients with TNBC, whose tumor relapsed following treatment with curative intent for early disease, which must have included immunotherapy and chemotherapy as part of the radical locoregional therapy (either adjuvant, neoadjuvant or both). 
Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology 
Intervention: Ceralasertib 
Start Date: 2022-12-15 
Last Updated: 2023-09-28 
Number of Patients: 37 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer Metastatic 

NCTID: NCT01562028

Title: BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC) 
Study Summary: Rationale:  Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations can only imperfectly predict outcome. The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways.  The investigators propose a model of treatment whereby patients with EGFR mutations (single or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Erlotinib 
Start Date: 2012-06 
Last Updated: 2022-08-24 
Number of Patients: 109 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT05654623

Title: A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. 
Study Summary: A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer. 
Sponsor: Pfizer 
Intervention: ARV-471 
Start Date: 2023-03-03 
Last Updated: 2023-09-21 
Number of Patients: 560 
Recruitment Status: RECRUITING 
Condition: Advanced Breast Cancer 

NCTID: NCT03125902

Title: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) 
Study Summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody 
Start Date: 2017-08-25 
Last Updated: 2023-02-15 
Number of Patients: 653 
Recruitment Status: COMPLETED 
Condition: Triple-Negative Breast Cancer 

NCTID: NCT04408118

Title: First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC 
Study Summary: This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate to evaluate the efficacy and safety of first line atezolizumab in combination with paclitaxel and bevacizumab (Avastin®) in patients with advanced or metastatic triple-negative breast cancer (mTNBC) 
Sponsor: MedSIR 
Intervention: Atezolizumab 
Start Date: 2020-10-05 
Last Updated: 2023-01-19 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT03230318

Title: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma 
Study Summary: This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of derazantinib by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) or FGFR2 gene mutations or amplifications (based on NGS testing performed or commissioned by the respective study center) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of derazantinib capsules. 
Sponsor: Basilea Pharmaceutica 
Intervention: derazantinib 
Start Date: 2017-11-10 
Last Updated: 2022-11-23 
Number of Patients: 148 
Recruitment Status: COMPLETED 
Condition: Intrahepatic Cholangiocarcinoma 

NCTID: NCT02052778

Title: A Study of TAS-120 in Patients With Advanced Solid Tumors 
Study Summary: This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:  # Dose escalation portion to determine the MTD and/ or RP2D of futibatinib. # Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer. # Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions). 
Sponsor: Taiho Oncology, Inc. 
Intervention: Futibatinib 
Start Date: 2014-07 
Last Updated: 2022-01-10 
Number of Patients: 386 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cholangiocarcinoma 

NCTID: NCT01989858

Title: ITACA-S2 (Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach) 
Study Summary: The study addresses two primary questions, according to its factorial design:  * to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study); * to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study).  The study has a 2x2 factorial design, thus consisting of two independent, following specific eligibility criteria and with different randomization scheme studies, the Timing Study and the RTX Study.  Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which is considered operable.  In the Timing Study patients fulfilling the eligibility criteria will be randomized with a 1:1 ratio to receive:  * peri-operative CHT (Arm A) or * post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be randomized in the RTX  Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment. This is possible since the randomization will be done in two steps: the first for the Timing Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the second one for the RTX Study, only for those centres with the radiotherapist willing and able to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms will be generated:  * peri-operative CHT (Arm A) * post-operative CHT (Arm B) * peri-operative CHT + post-operative CHT-RTX (Arm C) * post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more than one hundred experimental centres. Follow-up F(-up) procedures and timing of the visits will be consistent with current clinical practice.  Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in the RTX study. 
Sponsor: Mario Negri Institute for Pharmacological Research 
Intervention: peri-operative cht 
Start Date: 2010-11 
Last Updated: 2015-01-29 
Number of Patients: 1180 
Recruitment Status: TERMINATED 
Condition: Gastric Adenocarcinoma 

NCTID: NCT03945084

Title: Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy 
Study Summary: This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study conducted in patients affected by unresectable, locally advanced or metastatic urothelial cancer receiving niraparib plus best supportive care versus best supportive care as maintenance therapy after a first-line platinum-based chemotherapy.  The primary objective of the trial is to evaluate the efficacy of niraparib plus Best Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of progression-free survival (PFS), in patients with locally advanced or metastatic urothelial cancer that obtained disease control (objective response or stable disease) with first-line platinum-based chemotherapy. 
Sponsor: University of Turin, Italy 
Intervention: Niraparib 
Start Date: 2019-08-27 
Last Updated: 2022-05-23 
Number of Patients: 58 
Recruitment Status: COMPLETED 
Condition: Urothelial Carcinoma 

NCTID: NCT05754502

Title: Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy 
Study Summary: This is an observational, multi-centre study analysing data from patients treated with T-DM1 within the compassionate use program AL41711. During the compassionate use program AL41711, subjects received T-DM1 treatment for a total of 14 cycles or less, in case of disease recurrence or unmanageable toxicity. After the completion of the treatment, and 90 days of wash-out period, they can be enrolled in the study. After the signature of the Informed Consent Form, all their data reported in the medical charts up to then (as detailed in section 12 of the protocol) will be extracted retrospectively and inserted in the study database. From the end of the washout period following the last treatment with T-DM1, each subject will enter in an observation phase for a maximum of 3 years, or until death whichever happens first. This phase will be prospective after the signature of the Informed Consent Form. 
Sponsor: Consorzio Oncotech 
Intervention: Trastuzumab emtansine 
Start Date: 2021-07-27 
Last Updated: 2023-03-03 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04929223

Title: A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) 
Study Summary: This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results. 
Sponsor: Hoffmann-La Roche 
Intervention: Inavolisib 
Start Date: 2021-10-22 
Last Updated: 2023-11-13 
Number of Patients: 422 
Recruitment Status: RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT02834884

Title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access 
Study Summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: RP-1828 IMMUcan 
Start Date: 2017-05-03 
Last Updated: 2023-11-03 
Number of Patients: 4975 
Recruitment Status: RECRUITING 
Condition: All Tumor Types 

NCTID: NCT03673501

Title: A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib 
Study Summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off). 
Sponsor: Deciphera Pharmaceuticals LLC 
Intervention: DCC-2618 
Start Date: 2019-02-11 
Last Updated: 2021-01-06 
Number of Patients: 426 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Gastrointestinal Stromal Tumors 

NCTID: NCT03337724

Title: A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer 
Study Summary: This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Ipatasertib 
Start Date: 2018-01-06 
Last Updated: 2023-02-08 
Number of Patients: 580 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02003924

Title: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer 
Study Summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. 
Sponsor: Pfizer 
Intervention: Enzalutamide 
Start Date: 2013-10-31 
Last Updated: 2023-10-10 
Number of Patients: 1401 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Nonmetastatic Castration-Resistant Prostate Cancer 

NCTID: NCT04259944

Title: Post-surgical Liquid Biopsy-guided Treatment of Stage III and High-risk Stage II Colon Cancer Patients: the PEGASUS Trial 
Study Summary: PEGASUS is a prospective multi-centric study designed to prove the feasibility of using liquid biopsy to guide the post-surgical and post-adjuvant clinical management in 140 microsatellite stable Stage-III and T4N0 Stage-II colon cancer patients. 
Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology 
Intervention: CAPOX 
Start Date: 2020-06-16 
Last Updated: 2023-09-28 
Number of Patients: 140 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Colon Cancer 

NCTID: NCT04770896

Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab 
Study Summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2021-04-26 
Last Updated: 2023-11-13 
Number of Patients: 554 
Recruitment Status: RECRUITING 
Condition: Unresectable Hepatocellular Carcinoma 

NCTID: NCT02213744

Title: MM-302 Plus Trastuzumab vs. Chemotherapy of Physician’s Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients 
Study Summary: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician’s choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. 
Sponsor: Merrimack Pharmaceuticals 
Intervention: MM-302 
Start Date: 2014-07 
Last Updated: 2017-01-06 
Number of Patients: 113 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT05270044

Title: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. 
Study Summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). 
Sponsor: Pierre Fabre Medicament 
Intervention: Encorafenib and Binimetinib 
Start Date: 2022-05-02 
Last Updated: 2023-11-22 
Number of Patients: 815 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma 

NCTID: NCT03896074

Title: Atezolizumab Versus Atezolizumab Plus Bevacizumab as First Line in NSCLC Patients (BEAT) 
Study Summary: phase II controlled randomized study comparing atezolizumab as single agent to the combination of atezolizumab and bevacizumab in patients with chemonaive metastatic NSCLC with PD-L1 expression. All NSCLC patients with tumor tissue available for biomarker assessment and candidate for first-line therapy are considered eligible for the study. After evaluation of all inclusion and exclusion criteria and after informed consent signature all eligible patients will be randomized to atezolizumab (Arm A) or to the combination of atezolizumab and bevacizumab (Arm B). Disease assessment will be performed every 6 weeks. 
Sponsor: Fondazione Ricerca Traslazionale 
Intervention: Atezolizumab 
Start Date: 2019-05 
Last Updated: 2019-03-29 
Number of Patients: 206 
Recruitment Status: UNKNOWN 
Condition: Non-small-cell Lung Cancer Patients 

NCTID: NCT04660344

Title: A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy 
Study Summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2021-05-03 
Last Updated: 2023-10-10 
Number of Patients: 520 
Recruitment Status: RECRUITING 
Condition: Muscle-invasive Bladder Cancer 

NCTID: NCT03553836

Title: Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716) 
Study Summary: This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.  Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-09-12 
Last Updated: 2023-09-13 
Number of Patients: 976 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma 

NCTID: NCT05388669

Title: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer 
Study Summary: The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Lazertinib 
Start Date: 2022-08-05 
Last Updated: 2023-11-08 
Number of Patients: 418 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced or Metastatic Non-small Cell Lung Cancer 

NCTID: NCT04762069

Title: A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme 
Study Summary: This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria.  A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis. 
Sponsor: CNS Pharmaceuticals, Inc. 
Intervention: Berubicin 
Start Date: 2021-05-18 
Last Updated: 2023-09-13 
Number of Patients: 210 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Glioblastoma Multiforme, Adult 

NCTID: NCT01889069

Title: A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) 
Study Summary: This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period. 
Sponsor: Hoffmann-La Roche 
Intervention: Rituximab 
Start Date: 2013-07-31 
Last Updated: 2020-08-13 
Number of Patients: 159 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT05002569

Title: A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma 
Study Summary: The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma. 
Sponsor: Bristol-Myers Squibb 
Intervention: Nivolumab 
Start Date: 2021-10-19 
Last Updated: 2023-09-18 
Number of Patients: 1050 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma 

NCTID: NCT06117774

Title: Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) 
Study Summary: The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS). 
Sponsor: Amgen 
Intervention: Tarlatamab 
Start Date: 2024-01-27 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Limited Stage Small Cell Lung Cancer 

NCTID: NCT06119581

Title: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C 
Study Summary: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. 
Sponsor: Eli Lilly and Company 
Intervention: LY3537982 
Start Date: 2024-01-03 
Last Updated: 2023-11-07 
Number of Patients: 1016 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT06121401

Title: First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients 
Study Summary: The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy. 
Sponsor: Mario Negri Institute for Pharmacological Research 
Intervention: Olaparib 
Start Date: 2023-09-15 
Last Updated: 2023-11-07 
Number of Patients: 190 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Ovarian Epithelial 

NCTID: NCT03514901

Title: To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib. 
Study Summary: The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib. 
Sponsor: Intergruppo Melanoma Italiano 
Intervention: Experimental combination beyond Focal Progression 
Start Date: 2018-06-18 
Last Updated: 2021-12-02 
Number of Patients: 120 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma Metastatic 

NCTID: NCT03179436

Title: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) 
Study Summary: This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Quavonlimab 
Start Date: 2017-07-02 
Last Updated: 2023-02-08 
Number of Patients: 348 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced Solid Tumors 

NCTID: NCT03777657

Title: Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma 
Study Summary: This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. 
Sponsor: BeiGene 
Intervention: Tislelizumab 
Start Date: 2018-12-13 
Last Updated: 2023-09-15 
Number of Patients: 997 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Gastric, or Gastroesophageal Junction Adenocarcinoma 

NCTID: NCT06134440

Title: ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study 
Study Summary: Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients. 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Impact Oral® 
Start Date: 2023-11 
Last Updated: 2023-11-18 
Number of Patients: 200 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Colorectal Adenocarcinoma 

NCTID: NCT04303780

Title: Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). 
Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation 
Sponsor: Amgen 
Intervention: AMG 510 
Start Date: 2020-06-04 
Last Updated: 2023-10-23 
Number of Patients: 345 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC 

NCTID: NCT05198934

Title: Sotorasib and Panitumumab Versus Investigator’s Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation 
Study Summary: The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator’s choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator’s choice (trifluridine and tipiracil, or regorafenib). 
Sponsor: Amgen 
Intervention: Sotorasib 
Start Date: 2022-04-19 
Last Updated: 2023-09-21 
Number of Patients: 160 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Colorectal Cancer (CRC) 

NCTID: NCT05312398

Title: CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen 
Study Summary: This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status. 
Sponsor: University of Campania “Luigi Vanvitelli” 
Intervention: Cetuximab 
Start Date: 2021-07-15 
Last Updated: 2023-10-04 
Number of Patients: 200 
Recruitment Status: RECRUITING 
Condition: Metastatic Colorectal Adenocarcinoma 

NCTID: NCT04700124

Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) 
Study Summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-21 
Last Updated: 2023-11-18 
Number of Patients: 784 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Muscle Invasive Bladder Cancer 

NCTID: NCT04489940

Title: Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer 
Study Summary: The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test. 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Bintrafusp alfa 
Start Date: 2020-10-12 
Last Updated: 2023-04-10 
Number of Patients: 11 
Recruitment Status: TERMINATED 
Condition: Triple Negative Breast Neoplasms 

NCTID: NCT05296798

Title: A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) 
Study Summary: This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Phesgo 
Start Date: 2022-07-04 
Last Updated: 2023-11-28 
Number of Patients: 812 
Recruitment Status: RECRUITING 
Condition: Locally Advanced or Metastatic Breast Cancer 

NCTID: NCT05218499

Title: Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma 
Study Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.  The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.  During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment.  Participants can continue treatment in the study as long as they benefit from it and can tolerate it.  Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 907828 
Start Date: 2022-03-25 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Liposarcoma, Dedifferentiated 

NCTID: NCT05382299

Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer 
Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician’s choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1. 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy 
Start Date: 2022-07-20 
Last Updated: 2023-11-15 
Number of Patients: 540 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer 

NCTID: NCT04191499

Title: A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer 
Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. 
Sponsor: Hoffmann-La Roche 
Intervention: Inavolisib 
Start Date: 2020-01-29 
Last Updated: 2023-11-18 
Number of Patients: 325 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04526899

Title: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma 
Study Summary: This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent. 
Sponsor: BioNTech SE 
Intervention: BNT111 
Start Date: 2021-05-19 
Last Updated: 2023-11-28 
Number of Patients: 184 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma Stage III 

NCTID: NCT04730999

Title: Efficacy and Safety Study of a New Therapeutic Strategy in the Treatment of Extended-Disease Small-Cell Lung Cancer 
Study Summary: Small cell lung cancer (SCLC) is an aggressive type of neuroendocrine tumor with the majority of patients (about 60-70%) being diagnosed with metastatic disease and with a median survival ranging from 7 to 12 months. Combination chemotherapy (CT), namely a platinum and etoposide-based regimen, represents the cornerstone of treatment for extended disease (ED) SCLC. Despite this the duration of response is short and nearly all patients develop disease relapse or progression. The recent approval of atezolizumab in combination with carboplatin and etoposide as first line in patients with ED SCLC is surely a step forward in the understanding the molecular landscape and treatment of this complex tumor, but new therapeutic approaches need to be explored.  This trial aims to assess the efficacy in terms of 1 year survival a new therapeutic strategy that combines to the standard CT (carboplatin and etoposide), two drugs indicated in the tratment of several types of tumors: bevacizumab and atezolizomab.  The treatment will start with an induction phase during which eligible patients will receive, by intravenous way, a combination of the above mentioned drugs according to a specific administration regimen. This phase will last about 18 weeks. Therafter the treatment will proceed with a maintenence phase lasting for a maximum of 54 weeks during which the patients will receive only atezolizumab and bevacizumab, by intravenous way, according to a specific administration regimen. Treatment will be discontnued in case of disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit (for atezolizumab). During the study period the patients will undergo to periodic visits and laboratory, radiologic assessments to monitor the efficacy and the safety of the ongoing treatment. 
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica 
Intervention: Etoposide 
Start Date: 2020-07-01 
Last Updated: 2023-05-15 
Number of Patients: 52 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Small Cell Lung Cancer 

NCTID: NCT03451370

Title: First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer 
Study Summary: * Oxaliplatin-based doublets plus bevacizumab are standard first-line therapy options for patients (pts) with metastatic colorectal cancer (mCRC). Slight adjustments in chemo-dosage are commonly applied in routinely practice to elderly pts, but those modified schedules have never been standardized * The addition of oxaliplatin versus no oxaliplatin to treatment with 5-fluorouracil in older and frail untreated pts with mCRC resulted in a non-statistically significant trend toward improvement in Progression Free Survival (PFS) and a lack of benefit in Overall Survival (OS) * In elderly pts deemed unfit for an upfront combined chemotherapy a fluoropyrimide-based monotherapy plus bevacizumab is considered a reasonable first-line treatment * Clinical definition of elderly (over 70 years old) pts with CRC that may deserve a more or less intensive combination therapy is still debated. The cut-off of 75 years old combined with ECOG PS assessment is a reasonable approach for clearly defining candidates to different approaches * Several geriatric screening tools have been used to identify pts with a geriatric profile potentially predicting for overall survival and risk of toxicity. The G8 screening tool has been already validated in pts with cancer showing the strongest prognostic value for OS; the CRASH score is able to stratify pts according an estimated risk of treatment-related toxicities  On the basis of these considerations, we designed the present observational study of first-line therapy with bevacizumab in combination with capecitabine and oxaliplatin in previously untreated elderly pts affected by unresectable mCRC in order to evaluate its efficacy in real world practice (as measured by progression free survival) 
Sponsor: Istituto Oncologico Veneto IRCCS 
Intervention: Capecitabine 
Start Date: 2017-11-01 
Last Updated: 2023-11-29 
Number of Patients: 121 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Elderly Metastatic Colorectal Cancer Patients

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial