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A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02C
Substudy 02C 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 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
The Angeles Clinic and Research Institute ( Site 3009)
Los Angeles, California, United States
Providence Saint John's Health Center ( Site 3010)
Santa Monica, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 3012)
Aurora, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)
Baltimore, Maryland, United States
NYU Clinical Cancer Center ( Site 3002)
New York, New York, United States
Duke Cancer Institute ( Site 3005)
Durham, North Carolina, United States
Martha Morehouse Tower ( Site 3020)
Columbus, Ohio, United States
Oregon Health & Science University ( Site 3013)
Portland, Oregon, United States
University of Pennsylvania Abramson Cancer Center ( Site 3008)
Philadelphia, Pennsylvania, United States
West Cancer Center - East Campus ( Site 3014)
Germantown, Tennessee, United States
Start Date
June 26, 2020
Primary Completion Date
September 24, 2025
Completion Date
September 24, 2025
Last Updated
October 27, 2025
146
ACTUAL participants
Pembrolizumab
BIOLOGICAL
Vibostolimab
BIOLOGICAL
Gebasaxturev
BIOLOGICAL
MK-4830
BIOLOGICAL
Favezelimab + Pembrolizumab
BIOLOGICAL
ATRA
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT06066138
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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