Trials (Fondazione IRCCS- Istituto Nazionale dei Tumori di Milano)
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NCTID: NCT05594290
Title: Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery Study Summary: This is a window-of-opportunity study for patients with resectable Merkel Cell Carcinoma. The aim of this study is to test the activity of a course of chemo-immunotherapy followed by surgery in patients with operable Merkel cell carcinoma. Participants will receive one cycle of retifanlimab plus platinum-etoposide chemotherapy prior to their scheduled surgery. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Retifanlimab Start Date: 2022-12-07 Last Updated: 2023-01-05 Number of Patients: 36 Recruitment Status: RECRUITING Condition: Merkel Cell Carcinoma
NCTID: NCT03552003
Title: Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis Study Summary: The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Treatment for clinical practise Start Date: 2018-08-10 Last Updated: 2022-08-26 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Classical Hodgkin Lymphoma
NCTID: NCT03719690
Title: Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy Study Summary: An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up. Sponsor: Kura Oncology, Inc. Intervention: Tipifarnib Start Date: 2018-11-05 Last Updated: 2022-11-09 Number of Patients: 284 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HRAS Gene Mutation
NCTID: NCT05845450
Title: Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) Study Summary: This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Trastuzumab deruxtecan Start Date: 2023-05-11 Last Updated: 2023-09-21 Number of Patients: 112 Recruitment Status: RECRUITING Condition: Colorectal Cancer
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: NCT04221945
Title: Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-12 Last Updated: 2023-07-20 Number of Patients: 980 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Uterine Cervical Neoplasms
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: 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: NCT05249959
Title: Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients. Study Summary: This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C)) Start Date: 2022-04-21 Last Updated: 2023-07-21 Number of Patients: 56 Recruitment Status: RECRUITING Condition: Relapsed Mantle Cell Lymphoma
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: NCT02710643
Title: “MIRO” Molecularly Oriented Immuno-radio-therapy Study Summary: Phase II prospective multicenter study for stage I/II Follicular Lymphoma treated with involved-field radiotherapy (IFRT) at doses of 24 Gy) with or without Ofatumumab for 8 weekly doses on molecular basis. Patients with positive basal Bcl-2 will be followed every 3 months and with Bcl-2 detection every 6 months for 3 years. Patient with negative basal Bcl-2 will be followed every 3 months without further Bcl-2 detection. Ofatumumab treatment will be administered to: # Patients with positive basal PCR for Bcl-2-IgH rearrangement in BM and/or PB, resulting still positive after IFRT; # Patients with positive basal PCR for Bcl-2-IgH in Sponsor: Fondazione Italiana Linfomi - ETS Intervention: OFATUMUMAB Start Date: 2014-10 Last Updated: 2022-06-21 Number of Patients: 110 Recruitment Status: COMPLETED Condition: Follicular Lymphoma, Grade 1
NCTID: NCT03820986
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) Study Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-03-12 Last Updated: 2023-04-25 Number of Patients: 674 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Malignant Melanoma
NCTID: NCT03465722
Title: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST Study Summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs. Sponsor: Blueprint Medicines Corporation Intervention: avapritinib Start Date: 2018-03-26 Last Updated: 2022-10-06 Number of Patients: 476 Recruitment Status: COMPLETED Condition: GIST
NCTID: NCT04383119
Title: Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma Study Summary: Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype. Sponsor: Italian Sarcoma Group Intervention: Trabectedin Start Date: 2021-10-29 Last Updated: 2023-09-13 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Leiomyosarcoma of Ovary
NCTID: NCT02063685
Title: Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma Study Summary: Recently, the availability of R has substantially changed therapeutic approach to FL patients, since its combination with chemotherapy has improved response rates, progression free survival (PFS) and overall survival (OS). Based on the results of recently completed randomized studies the standard treatment for patients with FL should consist of an initial therapy with R-CHOP combination followed by two-year maintenance with R. Although results of randomized trials confirmed that this approach results in an improved patients’ outcome and made a step forward in the management of patients with FL, one important question that can be raised is if this approach is really needed for all patients with FL or if some of them could benefit from a reduced intensity treatment achieving the same results in terms of outcome and survival . This question is of particular interest for newly diagnosed patients for whom maintenance does not affect OS. More recent data demonstrated that the outcome of patients with FL can be further predicted by evaluating the quality of response to therapy studying minimal residual disease (MRD). This project addresses the objective of evaluating if combining clinical response assessed on FDG-PET scan and molecular response measured through MRD detection could permit to single out groups of patients at different risk of progression and to consequently modulate maintenance therapies, with the aim to provide clinicians a more rational use of the available diagnostic and therapeutic resources. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: R-CHOP or R-bendamustine Start Date: 2012-07 Last Updated: 2022-06-21 Number of Patients: 807 Recruitment Status: COMPLETED Condition: Follicular Non-Hodgkin’s Lymphoma
NCTID: NCT05257083
Title: A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients. Sponsor: European Myeloma Network Intervention: Daratumumab Start Date: 2023-10-10 Last Updated: 2023-11-18 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Multiple Myeloma
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: NCT05300282
Title: Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin’s Lymphoma Patients Study Summary: The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): # arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. # arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients’ prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Atezolizumab Start Date: 2022-08-03 Last Updated: 2023-09-15 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Hodgkin’s Lymphoma
NCTID: NCT04199104
Title: A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010) Study Summary: This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-02-05 Last Updated: 2023-11-02 Number of Patients: 511 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
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: NCT04817826
Title: TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC. Study Summary: INFINITY is a Phase II, multicentre, single-arm, multi-cohort trial aimed at evaluating the activity and safety of the combination of tremelimumab and durvalumab as neoadjuvant (Cohort 1) and definitive (Cohort 2) treatment for MSI-high gastric/gastroesophageal juction cancer patients eligible for radical surgery. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Durvalumab Start Date: 2021-04-01 Last Updated: 2023-10-31 Number of Patients: 31 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT04736706
Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-04-14 Last Updated: 2023-11-24 Number of Patients: 1653 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT02949791
Title: HIPEC Using High Intra-abdominal Pressure Study Summary: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as the best pharmacologic endpoint to assure the efficacy of HIPEC. The primary endpoints of the present phase II randomized study are to test whether the increased intra abdominal pressure (IAP) during HIPEC could: * enhance the penetration of cisplatin into the residual neoplastic and normal tissues; * elicit changes on pharmacokinetic advantage of cisplatin. Secondary endpoints are to evaluate the: * impact of high IAP on intraoperatory hemodynamic and respiratory parameters; * impact on short-term surgical outcomes (in hospital stay, morbidity, mortality). Patients affected by PC from colorectal cancer or pseudomyxoma peritonei, submitted to complete cytoreduction (residual disease <2.5mm) would be eligible for the study. HIPEC will be performed using closed abdomen technique and cisplatin + mitomycin-C. Patients will be randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be measured using bladder catheter. High IAP will be obtained increasing the volume of perfusate. Thirty-eight patients (19 in each study groups) will be enrolled in 30 months. The randomized groups will be stratified according to tumor type. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Cytoreductive surgery Start Date: 2014-12 Last Updated: 2018-02-23 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Pseudomyxoma Peritonei
NCTID: NCT01301391
Title: Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy Study Summary: The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy. Sponsor: Tiziana Life Sciences LTD Intervention: Milciclib Maleate Start Date: 2011-02-02 Last Updated: 2019-02-06 Number of Patients: 30 Recruitment Status: TERMINATED Condition: Malignant Thymoma
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: NCT06008691
Title: A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice Study Summary: This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: “novel” MAB (alone or in combination) Start Date: 2023-10 Last Updated: 2023-08-23 Number of Patients: 1500 Recruitment Status: NOT_YET_RECRUITING Condition: Non-Hodgkin Lymphoma, B-cell
NCTID: NCT01011439
Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Study Summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. Sponsor: Tiziana Life Sciences LTD Intervention: Milciclib Maleate Start Date: 2010-02-22 Last Updated: 2019-02-06 Number of Patients: 72 Recruitment Status: TERMINATED Condition: Thymic Carcinoma
NCTID: NCT05816850
Title: Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial Study Summary: This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: EZH2 mutations/CNAs by droplet digital PCR (ddPCR) Start Date: 2023-06-01 Last Updated: 2023-04-18 Number of Patients: 654 Recruitment Status: NOT_YET_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT04890067
Title: Observational Study in Localized Osteosarcoma Study Summary: Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized OsteoSarcoma (OS) treated according the AIEOP/Italian Sarcoma Group (ISG) OS 2021 Sponsor: Italian Sarcoma Group Intervention: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments) Start Date: 2021-07-30 Last Updated: 2023-09-13 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Localized Osteosarcoma
NCTID: NCT02709512
Title: Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Study Summary: This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die. Sponsor: Polaris Group Intervention: ADI-PEG 20 plus Pem Platinum Start Date: 2017-08-01 Last Updated: 2023-10-04 Number of Patients: 249 Recruitment Status: COMPLETED Condition: Mesothelioma
NCTID: NCT04447755
Title: A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) Study Summary: The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-07-30 Last Updated: 2023-10-04 Number of Patients: 127 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed or Refractory Solid Tumors
NCTID: NCT04197986
Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. Sponsor: QED Therapeutics, Inc. Intervention: Infigratinib Start Date: 2020-03-11 Last Updated: 2023-02-02 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Upper Tract Urothelial Carcinomas
NCTID: NCT03552692
Title: Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Study Summary: The FIL_VERT study is a phase II, open label, multicenter clinical trial. The primary of objective of the Study is to evaluate the efficacy of Venetoclax ABT-199/GDC-0199) in terms of overall response rate (ORR) in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH) Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Venetoclax Start Date: 2018-09-25 Last Updated: 2023-07-06 Number of Patients: 22 Recruitment Status: TERMINATED Condition: T-Cell Lymphoma Relapsed
NCTID: NCT02262221
Title: Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer Study Summary: Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1 month) after curative treatment will be randomized in two arms according to 2 different follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic evaltuations scheduled, but required only at the occurence of any signs or symptoms and Intensive Follow up approach (Arm B) with scheduled radiologic evaluations. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Scheduled radiologic evaluations Start Date: 2014-06 Last Updated: 2023-03-13 Number of Patients: 330 Recruitment Status: SUSPENDED Condition: Head and Neck Cancer
NCTID: NCT04586231
Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Study Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-02-25 Last Updated: 2023-08-14 Number of Patients: 708 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT04241185
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-19 Last Updated: 2023-11-27 Number of Patients: 636 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT03891355
Title: Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL Study Summary: This is a prospective, multicenter, single arm, phase II trial designed to evaluate activity and the safety of the combination of Carfilzomib (K), Lenalidomide (R) and Dexamethasone (D) in patients with mantle cell lymphoma (MCL) relapsed/refractory (R/R) or intolerant to BTK inhibitor (BTKi) monotherapy or BTKi containing regimens with active disease necessitating treatment. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Carfilzomib Start Date: 2019-09-30 Last Updated: 2022-09-15 Number of Patients: 16 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT03785964
Title: Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) Study Summary: This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). In the double-blind phase, half of the participants will receive nirogacestat while the other half will receive placebo. Once participants are eligible to roll into the open-label phase, they will receive nirogacestat. Sponsor: SpringWorks Therapeutics, Inc. Intervention: Nirogacestat oral tablet Start Date: 2019-04-17 Last Updated: 2023-06-28 Number of Patients: 142 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Desmoid Tumor
NCTID: NCT03833167
Title: Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630) Study Summary: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab 400 mg Start Date: 2019-04-01 Last Updated: 2023-11-27 Number of Patients: 430 Recruitment Status: RECRUITING Condition: Carcinoma, Squamous Cell
NCTID: NCT05321329
Title: Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients Study Summary: This is a phase II, mono institutional, non comparative study, evaluating adjuvant capecitabine in patients affected by KRAS mutated Pseudomyxoma peritonei treated with cytoreductive surgery and HIPEC. Patient will be treated with 8 cycles of the study regimen that include: Capecitabine 1250 mg/m2 PO BID day 1-14 q21 days Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Capecitabine Start Date: 2018-12-03 Last Updated: 2022-04-11 Number of Patients: 28 Recruitment Status: RECRUITING Condition: Pseudomyxoma Peritonei
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: NCT03833661
Title: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) Study Summary: The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: M7824 Start Date: 2019-03-26 Last Updated: 2023-10-25 Number of Patients: 159 Recruitment Status: COMPLETED Condition: Biliary Tract Cancer
NCTID: NCT03711032
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-12-24 Last Updated: 2023-11-27 Number of Patients: 1405 Recruitment Status: RECRUITING Condition: High-risk Non-muscle Invasive Bladder Cancer
NCTID: NCT04712292
Title: Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer Study Summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Since then, the COVID-19 pandemic has caused a detrimental effect of the national health care system, causing a drastic reduction of the screening programs for colorectal cancer and requiring the redistribution of the hospital resources from elective surgery to the care of patients with SARS-Cov_2 infection requiring admission. Sponsor: University of Bologna Intervention: Surgical procedure for confirmed or suspected colorectal cancer Start Date: 2020-09-08 Last Updated: 2022-02-28 Number of Patients: 15000 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms Malignant
NCTID: NCT03803436
Title: Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation Study Summary: The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Liver transplant Start Date: 2019-01-02 Last Updated: 2023-03-16 Number of Patients: 22 Recruitment Status: RECRUITING Condition: Liver Metastases
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: 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: NCT01763164
Title: Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma Study Summary: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival Sponsor: Pfizer Intervention: MEK162 Start Date: 2013-07-12 Last Updated: 2021-03-22 Number of Patients: 402 Recruitment Status: COMPLETED Condition: Metastatic or Unresectable Cutaneous Melanoma
NCTID: NCT03867084
Title: Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937) Study Summary: This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-28 Last Updated: 2023-09-08 Number of Patients: 950 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT00484341
Title: Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas. Study Summary: The main objective of the trial is to document the preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated with one or more prior systemic regimen. Sponsor: AGC Biologics S.p.A. Intervention: low-dose NGR-hTNF Start Date: 2010-10 Last Updated: 2018-08-29 Number of Patients: 69 Recruitment Status: COMPLETED Condition: Metastatic Adult Soft Tissue Sarcoma
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: NCT03567876
Title: Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL Study Summary: Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Venetoclax Start Date: 2018-09-03 Last Updated: 2023-09-13 Number of Patients: 141 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: NCT05976113
Title: A Retrospective Study on Multiple Classifier Endometrial Cancer Study Summary: Endometrial cancer is not a single entity but rather a very heterogeneous group of diseases. Historically, endometrial cancer patients have been classified as endometrioid (type I) or non-endometrioid (type II) according to the dualistic Bokhman model- However, this approach has been limited in accurately predicting prognosis and guiding treatment owing to heterogeneity within subtypes, inadequate incorporation of molecular and genetic information, and high interobserver variability . In the last ten years, after the publication of The Cancer Genome Atlas (TCGA)<math display="block">5</math>, the molecular classification of endometrial cancer into four molecular subtypes <math display="block">(i) POLE/ultramutated group (POLE mutated), (ii) mismatch repair deficiency/microsatellite-instable, hypermutated group (MMRd/MSI-H), (iii) copy-number-high, TP53-mutant (CNH/p53abn), and (iv) copy-number-low, TP53-wild-type (CNL, or No Specific Mutational Profile \[NSMP</math>)] has rapidly gained interest. Recently, the European Societies of Gynaecological Oncology, Radiotherapy and Oncology, and Pathology (ESGO-ESTRO-ESP), the European Society of Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN), and the new 2023 International Federation of Gynecology and Obstetrics (FIGO) staging system have promoted the use of (surrogate) molecular classification. Retrospective studies supported the value of adopting molecular classification to offer reliable data on prognostication and adjuvant treatment decisions. Although no prospective data are available, current guidelines promote the use of molecular profiles to tailor adjuvant treatment after surgery. As only a few retrospective studies have investigated the association between molecular profiles and response to various adjuvant treatments, it is important to note that data are limited. Interestingly, the growing adoption of molecular profiling led to the detection of a subgroup of tumors called multiple classifiers, characterized by multiple (two or three) molecular features. According to the guidelines, tumors with a POLE mutation should be considered POLEmut, regardless of other molecular features, whereas MMRd/MSI-H tumors with a p53 abnormality should be considered MMRd/MSI-H. Data on these patients is limited and fragmentary. The aforementioned consensus is based solely on a large retrospective cohort of multiple classifiers collected by Leon-Castillo et al.. Hence, to fill this literature gap, the investigators designed this retrospective study, which aimed to collect multiple classifiers patients to improve knowledge on this emerging category. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Observation only Start Date: 2023-07-27 Last Updated: 2023-08-04 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Uterine Cancer
NCTID: NCT03142334
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) Study Summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2017-06-09 Last Updated: 2023-06-29 Number of Patients: 994 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT03898180
Title: Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Study Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). With Amendment 3 (effective: September <math display="block">Sep</math>-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-06 Last Updated: 2023-10-31 Number of Patients: 487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT04380636
Title: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-07-06 Last Updated: 2023-11-07 Number of Patients: 870 Recruitment Status: RECRUITING Condition: Lung Neoplasms
