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)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02089685
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • PegIFN-2b — BIOLOGICAL
    Subcutaneous infusion
  • Ipilimumab — BIOLOGICAL
    IV infusion

Study Details

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.

Key Dates

Start date
Mar 17, 2014
Status verified
Aug 2022
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021

Study Design

Enrollment
295 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + PegIFN-2b
    Participants in Part 1A receive pembrolizumab intravenously (IV) 200 mg every three weeks (Q3W) + PEG-IFN at assigned dose subcutaneously (SC) once a week for up to \~2 years.
  • Experimental: Pembrolizumab + IPI Q3W
    Participants in Parts 1A and 1B receive pembrolizumab IV 200 mg Q3W for up to \~2 years + IPI IV 1 mg/kg Q3W for up to \~12 weeks.
  • Experimental: Pembrolizumab + IPI Q6W
    Participants in Part 1C receive pembrolizumab IV 200 mg Q3W for up to \~2 years + IPI IV 50 mg every 6 weeks (Q6W) for up to \~24 weeks.
  • Experimental: Pembrolizumab + IPI Q12W
    Participants in Part 1C receive pembrolizumab IV 200 mg Q3W for up to \~2 years + IPI IV 100 mg every 12 weeks (Q12W) for up to \~48 weeks.

Primary Outcome Measure

Percentage of Participants With Dose-limiting Toxicities (DLTs) (Part 1A) [ Time Frame: Up to ~6 Weeks ]

Related Studies