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Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2020-06-26
Completion Date
2025-09-24
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Vibostolimab
Administered via IV infusion at a specified dose on specified days
Gebasaxturev
Administered via IT injection at a specified dose on specified days
MK-4830
Administered via IV infusion at a specified dose on specified days
Favezelimab + Pembrolizumab
Administered via IV infusion at a specified dose on specified days
ATRA
Administered via oral capsules at a specified dose on specified days
Locations (29)
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
Inova Schar Cancer Institute ( Site 3011)
Fairfax, Virginia, United States
Melanoma Institute Australia ( Site 3402)
Wollstonecraft, New South Wales, Australia
Tasman Oncology Research Pty Ltd ( Site 3403)
Southport, Queensland, Australia
Fiona Stanley Hospital ( Site 3401)
Murdoch, Western Australia, Australia
Hopital La Timone ( Site 3103)
Marseille, Bouches-du-Rhone, France
Institut Claudius Regaud ( Site 3105)
Toulouse, Haute-Garonne, France
Centre Hospitalier Lyon Sud ( Site 3102)
Pierre-Bénite, Rhone, France
A.P.H. Paris, Hopital Saint Louis ( Site 3107)
Paris, France
Gustave Roussy ( Site 3101)
Villejuif, Île-de-France Region, France
HaEmek Medical Center ( Site 3703)
Afula, Israel
Rambam Health Care Campus-Oncology ( Site 3704)
Haifa, Israel
Hadassah Ein Karem Jerusalem ( Site 3702)
Jerusalem, Israel
Rabin Medical Center-Oncology ( Site 3705)
Petah Tikva, Israel
Chaim Sheba Medical Center ( Site 3701)
Ramat Gan, Israel
Istituto Europeo di Oncologia ( Site 3301)
Milan, Italy
Policlinico Le Scotte - A.O. Senese ( Site 3377)
Siena, Italy
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 3603)
Geneva, Canton of Geneva, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)
Lausanne, Canton of Vaud, Switzerland
Universitaetsspital Zuerich ( Site 3601)
Zuerich Flughafen, Canton of Zurich, Switzerland