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COMPLETED
NCT04305041
PHASE1/PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

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 02A

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-06-26

Completion Date

2025-08-25

Last Updated

2026-09-01

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Quavonlimab

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Vibostolimab

Administered via IV infusion at a specified dose on specified days

DRUG

Lenvatinib

Administered via oral capsules at a specified dose on specified days

DRUG

ATRA

Administered via oral capsules at a specified dose on specified days

Locations (36)

The Angeles Clinic and Research Institute ( Site 1009)

Los Angeles, California, United States

UCLA Hematology & Oncology ( Site 1004)

Los Angeles, California, United States

Providence Saint John's Health Center ( Site 1010)

Santa Monica, California, United States

University of Colorado, Anschutz Cancer Pavilion ( Site 1012)

Aurora, Colorado, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)

Baltimore, Maryland, United States

NYU Clinical Cancer Center ( Site 1002)

New York, New York, United States

Duke Cancer Institute ( Site 1005)

Durham, North Carolina, United States

Martha Morehouse Tower ( Site 1020)

Columbus, Ohio, United States

Oregon Health & Science University ( Site 1013)

Portland, Oregon, United States

University of Pennsylvania Abramson Cancer Center ( Site 1008)

Philadelphia, Pennsylvania, United States

West Cancer Center - East Campus ( Site 1014)

Germantown, Tennessee, United States

University of Texas MD Anderson Cancer Center ( Site 1006)

Houston, Texas, United States

Inova Schar Cancer Institute ( Site 1011)

Fairfax, Virginia, United States

Calvary Mater Newcastle-Medical Oncology ( Site 1404)

Waratah, New South Wales, Australia

Melanoma Institute Australia ( Site 1402)

Wollstonecraft, New South Wales, Australia

Tasman Oncology Research Pty Ltd ( Site 1403)

Southport, Queensland, Australia

Fiona Stanley Hospital ( Site 1401)

Murdoch, Western Australia, Australia

Hopital La Timone ( Site 1103)

Marseille, Bouches-du-Rhone, France

Hopital Saint Andre ( Site 1108)

Bordeaux, Gironde, France

Institut Claudius Regaud ( Site 1105)

Toulouse, Haute-Garonne, France

Centre Hospitalier Lyon Sud ( Site 1102)

Pierre-Bénite, Rhone, France

A.P.H. Paris, Hopital Saint Louis ( Site 1107)

Paris, France

Gustave Roussy ( Site 1101)

Villejuif, Île-de-France Region, France

HaEmek Medical Center ( Site 1703)

Afula, Israel

Rambam Health Care Campus-Oncology ( Site 1704)

Haifa, Israel

Hadassah Ein Karem Jerusalem ( Site 1702)

Jerusalem, Israel

Chaim Sheba Medical Center ( Site 1701)

Ramat Gan, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399)

Milan, Italy

Istituto Europeo di Oncologia ( Site 1301)

Milan, Italy

Istituto Nazionale Tumori Fondazione Pascale ( Site 1302)

Naples, Italy

Istituto Oncologico Veneto IRCCS ( Site 1355)

Padova, Italy

Policlinico Le Scotte - A.O. Senese ( Site 1377)

Siena, Italy

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1865)

Port Elizabeth, Eastern Cape, South Africa

Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1603)

Geneva, Canton of Geneva, Switzerland

CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602)

Lausanne, Canton of Vaud, Switzerland

Universitaetsspital Zuerich ( Site 1601)

Zuerich Flughafen, Canton of Zurich, Switzerland