Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04305054
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
  • Vibostolimab — BIOLOGICAL
    Administered via IV infusion at a specified dose on specified days
  • Pembrolizumab/Quavonlimab — BIOLOGICAL
    Administered via IV infusion at a specified dose on specified days
  • Lenvatinib — DRUG
    Administered via oral capsule at a specified dose on specified days
  • Favezelimab/Pembrolizumab — BIOLOGICAL
    Administered via IV infusion at a specified dose on specified days
  • ATRA — DRUG
    Administered via oral capsule at a specified dose on specified days

Study Details

Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment

Key Dates

Start date
Jul 1, 2020
Status verified
May 2026
Primary completion
May 18, 2026
Completion
May 18, 2026

Study Design

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

Arms

  • Experimental: Pembrolizumab + Vibostolimab
    Participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Active Comparator: Pembrolizumab
    Participants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Pembrolizumab/Quavonlimab
    Participants will receive coformulation of pembrolizumab and quavonlimab (MK-1308A) IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
    Participants will receive coformulation of pembrolizumab and quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Favezelimab/Pembrolizumab
    Participants will receive cofomulation of favezelimab + pembrolizumab (MK-4280A) IV at specified dose on specified days every 3 weeks (Q3W) for up to approximately 2 years
  • Experimental: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA)
    Participants will receive coformulation of favezelimab and pembrolizumab IV Q3W for up to 35 cycles, plus ATRA orally (for 3 days surrounding each infusion of MK-4280A, including Days 1, 2, and 3 of Cycle 1 and on Days -1, 1, and 2 of all subsequent cycles).
  • Experimental: Coformulation Favezelimab/Pembrolizumab + Vibostolimab
    Participants will receive coformulation of favezelimab and pembrolizumab (MK-4280A) IV and vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Primary Outcome Measure

Percentage of participants who experience a dose-limiting toxicity (DLT): Safety lead-in phase [ Time Frame: Up to ~3 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute ( Site 2009)Los AngelesCalifornia90025-
UCLA Hematology & Oncology ( Site 2004)Los AngelesCalifornia90095-
Providence Saint John's Health Center ( Site 2010)Santa MonicaCalifornia90404-
University of Colorado, Anschutz Cancer Pavilion ( Site 2012)AuroraColorado80045-
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026)GainesvilleFlorida32608-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)BaltimoreMaryland21287-
R.J. Zuckerberg Cancer Center ( Site 2032)Lake SuccessNew York11042-
NYU Clinical Cancer Center ( Site 2002)New YorkNew York10016-
Duke Cancer Institute ( Site 2005)DurhamNorth Carolina27710-
Martha Morehouse Tower ( Site 2020)ColumbusOhio43221-
Oregon Health & Science University ( Site 2013)PortlandOregon97239-
University of Pennsylvania Abramson Cancer Center ( Site 2008)PhiladelphiaPennsylvania19104-
West Cancer Center - East Campus ( Site 2014)GermantownTennessee38138-
Mays Cancer Center ( Site 2025)San AntonioTexas78229-
Inova Schar Cancer Institute ( Site 2011)FairfaxVirginia22031-

Find similar trials in Los Angeles, CA

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, COUniversity of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office· Gainesville, FLSidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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