Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants With Advanced Melanoma or Renal Cell Carcinoma (MK-3475-029/KEYNOTE-29)

Official Title

A Phase 1/2 Clinical Trial to Study the Safety and Tolerability of MK-3475 + Pegylated Interferon Alfa-2b (PEG-IFN) and MK-3475 + Ipilimumab (IPI) in Subjects With Advanced Melanoma (MEL) and Renal Cell Carcinoma (RCC) (KEYNOTE 029)

Summary:

This study is being done to analyze the safety, tolerability, and efficacy of treatment for advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated to permit continued clinical investigation.

Trial Description

Primary Outcome:

  • Number of participants with dose-limiting toxicities (Part 1A)
  • Number of participants experiencing adverse events (AEs)
  • Number of participants discontinuing study drug because of AEs
  • Progression-free survival (PFS) (Part 2)
  • Number of participants experiencing grade 3-5 drug-related AEs (Part 1C)
  • Objective response rate (ORR) (Part 1C)
Secondary Outcome:
  • ORR using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Part 1C)
  • ORR (Part 2)
  • Duration of Response (DOR) (Parts 1B, 1C)
  • Overall Survival (OS) (Parts 1B, 1C)
  • PFS (Parts 1B, 1C)
  • Number of participants experiencing grade 3-4 AEs
  • ORR using RECIST 1.1 (Part 1B)
The trial is being done in three parts: Part 1A (MEL and RCC) will define the maximum tolerated dose (MTD)/maximum administered dose (MAD) for the drug combinations; a recommended Phase 2 dose (RP2D) for each combination will be identified. Part 1B (MEL-single arm expansion) will better characterize safety and efficacy and provide preliminary efficacy data for the penbrolizumab + IPI combination in participants with MEL. Part 2 (MEL and RCC) is a randomized portion of the trial and will evaluate preliminary efficacy of the drug combinations given in 6-week cycles for advanced MEL participants. Part 2 was removed from the study with Amendment 3 of the protocol. Part 1C (MEL) is added as the third part of the study with Amendment 3. Part 1C will evaluate safety and efficacy for different doses and dosing intervals for IPI in combination with pembrolizumab in participants with advanced MEL.

View this trial on ClinicalTrials.gov

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Resources

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