119 results
Primary Objective:- to assess the effect of chemotherapy given concurrently with pembrolizumab on overall response rate (ORR) in NSCLC patients with high PD-L1 and high tumor burden Secondary Objectives: - to examine the effect of chemotherapy given…
Primary: • To assess the Major Pathological Response (MPR) rate (<= 10% of residual viable tumor cells) on the resected specimen at the time of surgery in all subjects randomized to canakinumab alone or in combination with pembrolizumab.…
This study is designed to assess the antitumor efficacy and safety of pembrolizumab + CRT following maximal TURBT compared with placebo + CRT following maximal TURBT for participants with newly diagnosed T2 T4aN0M0 MIBC who elect to receive CRT for…
Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…
Primary Objective: To compare the effectiveness of the administration of secukinumab to standard care in newly diagnosed Psoriatic Arthritis patients on the ACR50 response at 6 months. Secondary Objectives: To compare effectiveness at 6 and 12…
To estimate the objective response rate (ORR) by RECIST 1.1 in subjects with measurable disease assessed by central imaging vendor in Cohorts 1 and 2 combined, Cohort 1, Cohort 2 and Cohort 4.
To determine the immune-related progression free survival (irPFS) rate at 21 weeks and objective response rate (irORR) at 30 weeks in patients with pMMR CRC, dMMR mCRC, dMMR EC , dMMR SBC, dMMR SC treated with pembrolizumab combined with ataluren…
The purpose of this study is to demonstrate the impact on progression of structural damage in the spine as measured by the mSASSS in patients with AS. Data from this study will be used to support the submission of an AS label extension to include a…
Primary:- To evaluate the safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab- Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d…
Cohort ATo compare the CRR for the combination of pembrolizumab + BCG versus BCG alone in participants with CIS.Cohort B- To compare the EFS between participants who receive pembrolizumab + BCG (reduced maintenance) versus BCG alone- To compare the…
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…
MAIN OBJECTIVES:- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by progression-free survival (PFS) by blinded independent central review (BICR).- To compare the efficacy of Dato-DXd in…
Primary:• To compare progression free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the Intent to Treat (ITT) Analysis Set as assessed by investigators according to…
* To evaluate whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in participants who achieved a state of remission in Treatment Period 1* To evaluate efficacy of secukinumab on preventing…
The primary objective of this study is to evaluate ongoing responses in patients with advanced and metastatic melanoma who discontinue first-line monotherapy with nivolumab or pembrolizumab upon achieving CR or PR according to RECIST v1.1
Comparing the efficacy of encorafenib and cetuximab plus pembrolizumab (triplet group [group A]) vs. pembrolizumab (control group [group B]).Assessing the overall safety and tolerability of group A vs. group B.Assessing the efficacy of group A vs.…
Primary ObjectiveTo assess the effect of ALX148 plus pembrolizumab on 12-month overall survival (OS) rate and objective response rate (ORR) in patients withmetastatic or with unresectable, recurrent HNSCC that is PD-L1 positive (CPS >=1) and…
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…
Objectives:Primary:- Assess safety and tolerability of PDC*lung01 vaccinations administered at two dose levels as single agent or during maintenance treatment by pemetrexed (for adenocarcinomas in Cohorts A1 and A2) or during treatment with anti-PD-…