Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04305041
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Administered via IV infusion at a specified dose on specified days
  • Quavonlimab — BIOLOGICAL
    Administered via IV infusion at a specified dose on specified days
  • Vibostolimab — BIOLOGICAL
    Administered via IV infusion at a specified dose on specified days
  • Lenvatinib — DRUG
    Administered via oral capsules at a specified dose on specified days
  • ATRA — DRUG
    Administered via oral capsules at a specified dose on specified days

Study Details

Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.

Key Dates

First listed
Mar 12, 2020
Start date
Jun 26, 2020
Status verified
Jul 2026
Primary completion
Aug 25, 2025
Completion
Aug 25, 2025

Study Design

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

Arms

  • Experimental: Pembrolizumab + Quavonlimab + Vibostolimab
    Participants will receive pembrolizumab intravenously (IV) plus quavonlimab IV plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Pembrolizumab + Quavonlimab + Lenvatinib
    Participants will receive pembrolizumab IV plus quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Pembrolizumab + all-trans retinoic acid (ATRA)
    Participants will receive pembrolizumab IV plus ATRA orally at specified doses on specified days for a total treatment duration of up to approximately 2 years

Primary Outcome Measure

Percentage of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 39 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute ( Site 1009)Los AngelesCalifornia90025-
UCLA Hematology & Oncology ( Site 1004)Los AngelesCalifornia90095-
Providence Saint John's Health Center ( Site 1010)Santa MonicaCalifornia90404-
University of Colorado, Anschutz Cancer Pavilion ( Site 1012)AuroraColorado80045-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)BaltimoreMaryland21287-
NYU Clinical Cancer Center ( Site 1002)New YorkNew York10016-
Duke Cancer Institute ( Site 1005)DurhamNorth Carolina27710-
Martha Morehouse Tower ( Site 1020)ColumbusOhio43221-
Oregon Health & Science University ( Site 1013)PortlandOregon97239-
University of Pennsylvania Abramson Cancer Center ( Site 1008)PhiladelphiaPennsylvania19104-
West Cancer Center - East Campus ( Site 1014)GermantownTennessee38138-
University of Texas MD Anderson Cancer Center ( Site 1006)HoustonTexas77030-
Inova Schar Cancer Institute ( Site 1011)FairfaxVirginia22031-

Find similar trials in Los Angeles, CA

Nationwide
Melanoma trialsOncology trialsSkin cancer trialsDermatology trials
By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUCLA Hematology & Oncology· Los Angeles, CAProvidence Saint John's Health Center· Santa Monica, CAUniversity of Colorado, Anschutz Cancer Pavilion· Aurora, COSidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDNYU Clinical Cancer Center· New York, NY

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