Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

Official Title

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03B

Summary:

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Trial Description

Primary Outcome:

• Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)
• Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs)
• Safety Lead-in Phase: Number of participants who discontinue study treatment due to an AE
• Efficacy Phase: Number of participants who experienced DLTs
• Efficacy Phase: Number of participants who experience one or more AEs
• Efficacy Phase: Number of participants who discontinue study treatment due to an AE
• Efficacy Phase: Objective response rate (ORR)

• Efficacy Phase: Duration of response (DOR)
• Efficacy Phase: Progression-free survival (PFS)
• Efficacy Phase: Overall survival (OS)
• Efficacy Phase: Clinical benefit rate (CBR)

View this trial on ClinicalTrials.gov