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A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…

A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the
Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients with Advanced Melanoma

1. To evaluate progression-free-survival (PFS) in patients with advanced MEL receiving either Pembrolizumab or IPI.2. To evaluate overall survival (OS) in patients with advanced MEL receiving either Pembrolizumab or IPI.

Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…

A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer

Primary Objectives:(1) Objective: To compare the overall survival (OS) in subjects with R/M HNSCC treated with pembrolizumab compared to standard treatment.Secondary Objectives:PD-L1 Positive Population:(1) Objective: To compare Overall Survival (OS…

A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…

A Phase II clinical trial of MK-3475 (pembrolizumab) in subjects with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)

Primary objectives:(1) To determine the safety and tolerability of pembrolizumab. (2) To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (…

A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs. Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects with Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus that have Progressed after First-Line Standard Therapy (KEYNOTE-181)

Primary:1) To compare OS in subjects with squamous cell carcinoma of the Esophagus.2) To compare OS in subjects with PD-L1 Combined Positive Score (CPS)*10%3) To compare OS in all subjectsSecondary:1) To evaluate the progression free survival (PFS)…

Open-label single arm phase II study on pembrolizumab for recurrent primary central nervous sytem lymphoma

Primary objective To evaluate the Overall Response Rate (CR/PRrate) in patients treated with pembrolizumab for recurrent or progressive PCNSL after MTX-based first-line therapy To evaluate the safety of pembrolizumab in subjects diagnosed with…

Randomized, Phase II Study of Pembrolizumab (MK-3475) versus Chemotherapy in Patients with Advanced Melanoma (KEYNOTE 002).

1. To evaluate the progression-free-survival (PFS) in patients with ipilimumab refractory advanced MEL receiving either MK-3475 or chemotherapy.2. To evaluate the overall survival (OS) in patients with ipilimumab refractory advanced MEL receiving…

Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra)

Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…

A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Non-Small Cell Lung Cancer

1) Objective: To compare the overall survival (OS) of previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel.2) Objective: To compare progression-free survival (PFS) per RECIST 1.1 by…

A phase III, open-label, multicenter, two-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab versus pembrolizumab in patients with previously untreated advanced BRAFv600 wild-type melanoma

To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (KEYNOTE-252 / ECHO-301).

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with unresectable or…

A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma

Objectives: To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1 positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy(b) Pembrolizumab versus…

An Open-label, Randomized, Phase I/II Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer

Primary Objectivea) Phase I (Safety Run-in) The primary objective of the Phase I Safety Run-in part is to investigate the safety of IO102 in combination with either pembrolizumab alone or pembrolizumab and chemotherapy (carboplatin and pemetrexed)…

A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

This study has been transitioned to CTIS with ID 2022-502526-41-00 check the CTIS register for the current data. Objective- To evaluate anti-tumor activity of pembrolizumab (MK-3475) by evaluating the absence of high risk NMIBC or progressive…

A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or Metastatic Urothelial Cancer

Primary Objective:To evaluate the anti-tumor activity of pembrolizumab (MK-3475) (200 mg Q3W) as 1L therapy in subjects with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. Objective…

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician*s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) * (KEYNOTE-119)

The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…

A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel;Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)

Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…

89Zirconium-labeled pembrolizumab as predictive imaging biomarker of response and toxicity in pembrolizumab treated patients with non-small-cell lung cancer - a feasibility study

To assess the safety and biodistribution of 89Zr-pembrolizumab and its uptake in tumor and target irAE tissues