Trials (Georges-François Leclerc Cancer Center)
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NCTID: NCT02947685
Title: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Study Summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer. Sponsor: Alliance Foundation Trials, LLC. Intervention: palbociclib Start Date: 2017-06-21 Last Updated: 2023-05-30 Number of Patients: 496 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HER-2 Positive Breast Cancer
NCTID: NCT03974022
Title: Assessing an Oral EGFR Inhibitor, DZD9008 in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) Study Summary: This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy. Sponsor: Dizal Pharmaceuticals Intervention: DZD9008 Start Date: 2019-07-09 Last Updated: 2023-09-28 Number of Patients: 336 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT03840915
Title: M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) Study Summary: The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Cisplatin Start Date: 2019-04-02 Last Updated: 2023-08-21 Number of Patients: 70 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
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: NCT04721015
Title: Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires. Sponsor: AbbVie Intervention: ABBV-637 Start Date: 2021-02-23 Last Updated: 2023-10-17 Number of Patients: 81 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors Cancer
NCTID: NCT04698915
Title: Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer Study Summary: GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic Sponsor: Galera Therapeutics, Inc. Intervention: Drug GC4711 Start Date: 2021-05-07 Last Updated: 2023-08-03 Number of Patients: 160 Recruitment Status: RECRUITING Condition: SBRT
NCTID: NCT04949256
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-28 Last Updated: 2023-11-24 Number of Patients: 862 Recruitment Status: RECRUITING Condition: Metastatic Esophageal Squamous Cell Carcinoma
NCTID: NCT00932451
Title: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Study Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066. Sponsor: Pfizer Intervention: PF-02341066 Start Date: 2010-01 Last Updated: 2017-01-13 Number of Patients: 1069 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
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: NCT05063786
Title: Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) Study Summary: Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer. Sponsor: Spanish Breast Cancer Research Group Intervention: Trastuzumab Start Date: 2021-09-14 Last Updated: 2023-03-24 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Advanced Breast Cancer
NCTID: NCT03248492
Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Study Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2017-08-25 Last Updated: 2023-11-15 Number of Patients: 253 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04189445
Title: Futibatinib in Patients With Specific FGFR Aberrations Study Summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma <math display="block">iCCA</math>); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements. Sponsor: Taiho Oncology, Inc. Intervention: Futibatinib Start Date: 2020-08-24 Last Updated: 2023-06-06 Number of Patients: 115 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced or Metastatic Solid Tumor
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: NCT05198804
Title: A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer Study Summary: This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib in subjects with platinum-resistant ovarian cancer. Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Intervention: ZN-c3 Start Date: 2022-01-27 Last Updated: 2023-06-18 Number of Patients: 138 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT00069745
Title: Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen Study Summary: PURPOSE: The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC). TARGET PATIENT POPULATION: The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial. RATIONALE: There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy Sponsor: Agennix Intervention: Satraplatin Start Date: 2003-09 Last Updated: 2012-08-07 Number of Patients: NA Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT05029882
Title: Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 460 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. In the dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2i) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2ii), squamous NSCLC (Part 2iii), GEA <math display="block">Part 3</math> will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive intravenous (IV) ABBV-400 monotherapy in expansion <math display="block">Part 4</math>, and participants MET amplification will receive intravenous (IV) ABBV-400 monotherapy in expansion <math display="block">Part 5</math>. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Sponsor: AbbVie Intervention: ABBV-400 Start Date: 2021-10-13 Last Updated: 2023-11-02 Number of Patients: 460 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT00932893
Title: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Study Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug. Sponsor: Pfizer Intervention: PF-02341066 Start Date: 2009-09 Last Updated: 2017-01-02 Number of Patients: 347 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03563716
Title: A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Study Summary: This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation. Sponsor: Genentech, Inc. Intervention: Atezolizumab Start Date: 2018-08-10 Last Updated: 2023-11-09 Number of Patients: 135 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. 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 will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-21 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT03555149
Title: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) Study Summary: A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms. Sponsor: Hoffmann-La Roche Intervention: Regorafenib Start Date: 2018-09-27 Last Updated: 2023-11-07 Number of Patients: 96 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT01740427
Title: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) Study Summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease. Sponsor: Pfizer Intervention: PD-0332991 Start Date: 2013-02-22 Last Updated: 2022-12-08 Number of Patients: 666 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasms
NCTID: NCT00943826
Title: A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma Study Summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously <math display="block">IV</math> once every 2 week <math display="block">q2w</math>) or the placebo arm, in combination with radiation therapy (total dose 60 Gray <math display="block">Gy</math>, administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared <math display="block">mg/m\^2</math> oral administration <math display="block">po</math> daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks <math display="block">q3w</math>) or placebo monotherapy continued. The time on study treatment was until disease progression. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2009-06-29 Last Updated: 2017-09-25 Number of Patients: 921 Recruitment Status: COMPLETED Condition: Glioblastoma
NCTID: NCT01792726
Title: A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. Study Summary: TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life. Sponsor: University College, London Intervention: Boost to the tumour bed Start Date: 2013-06 Last Updated: 2019-07-12 Number of Patients: 1796 Recruitment Status: UNKNOWN Condition: Early Breast Cancer
NCTID: NCT05249426
Title: A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer Study Summary: This study is open to adults with head and neck cancer or liver cancer. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants’ health and take note of any unwanted effects. Sponsor: Boehringer Ingelheim Intervention: BI 765063 Start Date: 2022-02-25 Last Updated: 2023-11-28 Number of Patients: 45 Recruitment Status: RECRUITING Condition: Head and Neck Squamous Cell Carcinoma (HNSCC)
NCTID: NCT00083304
Title: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer Study Summary: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Efaproxiral Start Date: 2004-02 Last Updated: 2013-05-10 Number of Patients: 368 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04675827
Title: De-escalation Adjuvant Chemo in HER2+/ER-
ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade
Study Summary: DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment). Sponsor: Jules Bordet Institute Intervention: Pertuzumab and tratuzumab fixed dose combination Start Date: 2022-01-17 Last Updated: 2023-09-05 Number of Patients: 1065 Recruitment Status: SUSPENDED Condition: HER2-positive Breast Cancer
NCTID: NCT03468426
Title: A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours Study Summary: This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab. BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink. The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants. Sponsor: Boehringer Ingelheim Intervention: BI 836880 Start Date: 2018-05-03 Last Updated: 2023-11-28 Number of Patients: 252 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-squamous, Non-Small-Cell Lung Cancer
NCTID: NCT03428217
Title: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma Study Summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC). Sponsor: Calithera Biosciences, Inc Intervention: CB-839 Start Date: 2018-04-24 Last Updated: 2023-03-20 Number of Patients: 444 Recruitment Status: COMPLETED Condition: Advanced Renal Cell Carcinoma
NCTID: NCT03390504
Title: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Study Summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-<math display="block">L</math>1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2018-03-23 Last Updated: 2023-11-13 Number of Patients: 629 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Cancer
NCTID: NCT03941093
Title: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer Study Summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G
P) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.
Sponsor: FibroGen Intervention: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX Start Date: 2019-05-10 Last Updated: 2022-12-27 Number of Patients: 284 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Cancer Non-resectable
NCTID: NCT03194893
Title: A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer Study Summary: The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2017-07-05 Last Updated: 2023-11-02 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Neoplasms
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: NCT05650879
Title: ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer Study Summary: The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer. Sponsor: Enliven Therapeutics Intervention: ELVN-002 Start Date: 2023-03-20 Last Updated: 2023-11-09 Number of Patients: 178 Recruitment Status: RECRUITING Condition: HER2 Mutant Non-small Cell Lung Cancer
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT04526106
Title: REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Study Summary: This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3). Sponsor: Relay Therapeutics, Inc. Intervention: RLY-4008 Start Date: 2020-09-02 Last Updated: 2023-10-25 Number of Patients: 550 Recruitment Status: RECRUITING Condition: FGFR2 Amplification
NCTID: NCT03906071
Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Study Summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. Sponsor: Mirati Therapeutics Inc. Intervention: Nivolumab Start Date: 2019-07-15 Last Updated: 2023-10-24 Number of Patients: 532 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT04641871
Title: Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies Study Summary: The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations Sponsor: Symphogen A/S Intervention: Sym021 Start Date: 2020-10-12 Last Updated: 2023-09-13 Number of Patients: 148 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Cancer
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: 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: NCT02811861
Title: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma Study Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review <math display="block">IIR</math> using Response Evaluation Criteria in Solid Tumors <math display="block">RECIST 1.1</math>) as first-line treatment in participants with advanced renal cell carcinoma (RCC). Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2016-10-13 Last Updated: 2023-07-10 Number of Patients: 1069 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT03529110
Title: DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Study Summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (T-DXd) Start Date: 2018-08-09 Last Updated: 2023-02-09 Number of Patients: 524 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03486873
Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-08-21 Last Updated: 2023-11-27 Number of Patients: 2300 Recruitment Status: RECRUITING Condition: Solid Tumors
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: NCT04595565
Title: Sacituzumab Govitecan in Primary HER2-negative Breast Cancer Study Summary: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting. Sponsor: German Breast Group Intervention: Capecitabine Start Date: 2020-10-28 Last Updated: 2023-03-02 Number of Patients: 1332 Recruitment Status: RECRUITING Condition: HER2-negative Breast Cancer
NCTID: NCT03975647
Title: A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. Sponsor: Seagen Inc. Intervention: tucatinib Start Date: 2019-10-02 Last Updated: 2023-11-21 Number of Patients: 565 Recruitment Status: RECRUITING Condition: HER2-positive Breast 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: NCT02796261
Title: Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients Study Summary: The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy. Sponsor: Orbus Therapeutics, Inc. Intervention: Eflornithine Start Date: 2016-07 Last Updated: 2022-01-21 Number of Patients: 343 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Anaplastic Astrocytoma
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: 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: NCT05459129
Title: A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer) Study Summary: This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus (HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2023-04-13 Last Updated: 2023-11-07 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT04221035
Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vincristine Start Date: 2019-11-05 Last Updated: 2023-02-13 Number of Patients: 800 Recruitment Status: RECRUITING Condition: High-Risk Neuroblastoma
NCTID: NCT03126435
Title: EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX Study Summary: The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure. Sponsor: SynCore Biotechnology Co., Ltd. Intervention: EndoTAG-1 Start Date: 2018-10-16 Last Updated: 2023-05-06 Number of Patients: 218 Recruitment Status: COMPLETED Condition: Metastatic Pancreas Cancer
NCTID: NCT02402842
Title: Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma Study Summary: Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients’ death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent. Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen. Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients. Sponsor: Centre Hospitalier Universitaire de Besancon Intervention: Docetaxel, Cisplatin and 5-Fluorouracil Start Date: 2014-09 Last Updated: 2022-05-16 Number of Patients: 70 Recruitment Status: COMPLETED Condition: Anal Canal Carcinoma
NCTID: NCT03778931
Title: Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Study Summary: This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) . Sponsor: Stemline Therapeutics, Inc. Intervention: Elacestrant Start Date: 2019-05-10 Last Updated: 2022-07-22 Number of Patients: 466 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast 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: NCT04538664
Title: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Study Summary: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations. Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2020-10-13 Last Updated: 2023-10-11 Number of Patients: 308 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03809988
Title: PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) Study Summary: Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC) Sponsor: MedSIR Intervention: Palbociclib Start Date: 2019-04-05 Last Updated: 2023-09-07 Number of Patients: 198 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01479465
Title: Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma Study Summary: The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen. Sponsor: Gilead Sciences Intervention: Simtuzumab Start Date: 2011-12 Last Updated: 2019-04-17 Number of Patients: 266 Recruitment Status: TERMINATED Condition: Colorectal Cancer
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: NCT02340221
Title: A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy Study Summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years. Sponsor: Hoffmann-La Roche Intervention: Taselisib Start Date: 2015-04-09 Last Updated: 2022-07-12 Number of Patients: 631 Recruitment Status: TERMINATED Condition: Breast Cancer
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: 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: 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: NCT01524978
Title: A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers Study Summary: This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed. Sponsor: Hoffmann-La Roche Intervention: cetuximab Start Date: 2012-04-12 Last Updated: 2017-11-20 Number of Patients: 208 Recruitment Status: COMPLETED Condition: Multiple Myeloma, 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: NCT05183984
Title: Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer Study Summary: Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab. Sponsor: ARCAGY/ GINECO GROUP Intervention: Chemotherapy Start Date: 2022-02-01 Last Updated: 2022-12-06 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT02952534
Title: A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Study Summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2017-02-15 Last Updated: 2023-06-09 Number of Patients: 277 Recruitment Status: COMPLETED Condition: Metastatic Castration Resistant Prostate Cancer
NCTID: NCT05498428
Title: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation <math display="block">SC-CF</math>) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2022-11-11 Last Updated: 2023-11-18 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Carcinoma, Non-small-Cell Lung
NCTID: NCT05094336
Title: AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors Study Summary: The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors. Sponsor: Amgen Intervention: AMG 193 Start Date: 2022-02-01 Last Updated: 2023-11-09 Number of Patients: 527 Recruitment Status: RECRUITING Condition: Advanced MTAP-null Solid Tumors
NCTID: NCT02975934
Title: A Study of Rucaparib Versus Physician’s Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Study Summary: The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician’s choice of abiraterone acetate, enzalutamide, or docetaxel. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2017-06-13 Last Updated: 2023-11-07 Number of Patients: 405 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Castration Resistant Prostate Cancer
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: NCT01588184
Title: An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study Study Summary: This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2012-07-13 Last Updated: 2020-11-05 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Neoplasms
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: NCT03386734
Title: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer Study Summary: SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This “validation study” will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm). There will be a “quality assurance” program which will be developed in participating centers with detailed requirements in terms of surgeons’ qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the “safety algorithm”. Sponsor: Centre Hospitalier Universitaire de Besancon Intervention: SLN biopsy only Start Date: 2018-05-03 Last Updated: 2022-07-28 Number of Patients: 988 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT01835236
Title: Trastuzumab & Pertuzumab Followed by T-DM1 in MBC Study Summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician’s discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer. Sponsor: Swiss Group for Clinical Cancer Research Intervention: Trastuzumab Start Date: 2013-03-03 Last Updated: 2021-03-30 Number of Patients: 208 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT01118624
Title: Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer Study Summary: The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation. Sponsor: Acrotech Biopharma Inc. Intervention: Pralatrexate Injection Start Date: 2010-03 Last Updated: 2020-01-07 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00812240
Title: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) Study Summary: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) Sponsor: AB Science Intervention: Masitinib Start Date: 2009-01 Last Updated: 2023-02-01 Number of Patients: 335 Recruitment Status: TERMINATED Condition: Gastrointestinal Stromal 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: NCT04601857
Title: Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma Study Summary: The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens. Sponsor: Taiho Oncology, Inc. Intervention: futibatinib and pembrolizumab Start Date: 2021-01-21 Last Updated: 2023-10-10 Number of Patients: 46 Recruitment Status: RECRUITING Condition: Advanced and Metastatic Urothelial Cancer
NCTID: NCT05678257
Title: A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer Study Summary: This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer. A total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms. Sponsor: NuCana plc Intervention: Fosifloxuridine Nafalbenamide Start Date: 2023-04-18 Last Updated: 2023-10-10 Number of Patients: 171 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT02517398
Title: MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Study Summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: MSB0011359C Start Date: 2015-08-31 Last Updated: 2022-06-15 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT04497844
Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Study Summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS). Sponsor: Janssen Research & Development, LLC Intervention: Niraparib Start Date: 2020-09-23 Last Updated: 2023-11-09 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Castration-sensitive Prostate Cancer
NCTID: NCT02477644
Title: Platine, Avastin and OLAparib in 1st Line Study Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance. Sponsor: Arcagy Research Intervention: Olaparib Start Date: 2015-05-06 Last Updated: 2022-08-02 Number of Patients: 806 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT05186974
Title: Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Study Summary: The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy (SG) Start Date: 2022-05-30 Last Updated: 2023-10-02 Number of Patients: 193 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT04854499
Title: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma Study Summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC). Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2021-09-07 Last Updated: 2023-11-24 Number of Patients: 230 Recruitment Status: RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT04827576
Title: Study of Magrolimab in Patients With Solid Tumors Study Summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in patients with solid tumors. Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2021-10-01 Last Updated: 2023-11-18 Number of Patients: 116 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT05888844
Title: A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma Study Summary: This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma. Sponsor: Incyte Corporation Intervention: INCB099280 Start Date: 2023-10-09 Last Updated: 2023-11-24 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Cutaneous Squamous Cell Carcinoma
NCTID: NCT01801111
Title: A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment Study Summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib. Sponsor: Hoffmann-La Roche Intervention: Erlotinib Start Date: 2013-06-20 Last Updated: 2018-11-02 Number of Patients: 138 Recruitment Status: COMPLETED Condition: Non-Small-Cell Lung Carcinoma
NCTID: NCT04083976
Title: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Study Summary: The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations. Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2019-11-20 Last Updated: 2023-11-13 Number of Patients: 316 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT03767335
Title: MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer Study Summary: The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer Sponsor: Menarini Group Intervention: MEN1611 Start Date: 2018-07-19 Last Updated: 2023-05-24 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced or Metastatic Breast Cancer
