109 results
Primary ObjectiveThe primary objective of this double-blind, randomized, placebo-controlled, Phase 3 study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA amyloidosis. Efficacy will be assessed by the time…
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 (…
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)…
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…
To assess the safety and biodistribution of 89Zr-pembrolizumab and its uptake in tumor and target irAE tissues
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…
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…
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…
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)…
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
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…
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-…
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/…
The primary objective is to compare the OS in patients treated with IMCgp100 monotherapy versus Investigator*s Choice in HLA-A*0201 positive patients with advanced UM with no prior treatment in the metastatic setting. The secondary objectives of the…
OX40 agonists have been shown to increase antitumor immunity and improve tumor-free survival in non-clinical models and OX40 agonist monoclonal antibodies (mAbs) are currently being evaluated in Phase I clinical trials. GSK3174998 is a humanized…
Primary ObjectivesParts 2To evaluate the safety and tolerability of INCB001158 for patients with advanced/metastatic and/or treatment-refractory solid tumorsParts 3To evaluate the safety and tolerability of INCB001158 in combination with…
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…
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…
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…
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…