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COMPLETED
NCT04303169
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Vibostolimab

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Gebasaxturev

Administered via IT injection at a specified dose on specified days

BIOLOGICAL

MK-4830

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Favezelimab + Pembrolizumab

Administered via IV infusion at a specified dose on specified days

DRUG

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