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)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

April 20, 2026

Study Completion Date

April 20, 2026

Conditions
Melanoma
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

Pembrolizumab/Quavonlimab

Administered via IV infusion at a specified dose on specified days

DRUG

Lenvatinib

Administered via oral capsule 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 capsule at a specified dose on specified days

Trial Locations (60)

1011

CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602), Lausanne

1211

Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603), Geneva

2065

Melanoma Institute Australia ( Site 2402), Wollstonecraft

2196

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863), Sandton

2298

Calvary Mater Newcastle-Medical Oncology ( Site 2404), Waratah

4120

Tasman Oncology Research Pty Ltd ( Site 2403), Southport

6055

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865), Port Elizabeth

6150

Fiona Stanley Hospital ( Site 2401), Murdoch

6720

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 2221), Szeged

7570

Cape Town Oncology Trials ( Site 2864), Cape Town

8058

Universitaetsspital Zuerich ( Site 2601), Zuerich Flughafen

10016

NYU Clinical Cancer Center ( Site 2002), New York

11042

R.J. Zuckerberg Cancer Center ( Site 2032), Lake Success

13005

Hopital La Timone ( Site 2103), Marseille

19104

University of Pennsylvania Abramson Cancer Center ( Site 2008), Philadelphia

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399), Milan

20141

Istituto Europeo di Oncologia ( Site 2301), Milan

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022), Baltimore

22031

Inova Schar Cancer Institute ( Site 2011), Fairfax

27710

Duke Cancer Institute ( Site 2005), Durham

28034

Hospital Universitario Ramón y Cajal ( Site 2802), Madrid

31059

Institut Claudius Regaud ( Site 2105), Toulouse

32608

University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026), Gainesville

33075

CHU de Bordeaux- Hopital Saint Andre ( Site 2108), Bordeaux

35128

Istituto Oncologico Veneto IRCCS ( Site 2355), Padua

38138

West Cancer Center - East Campus ( Site 2014), Germantown

43221

Martha Morehouse Tower ( Site 2020), Columbus

53100

Policlinico Le Scotte - A.O. Senese ( Site 2377), Siena

69495

C.H. Lyon Sud ( Site 2102), Pierre-Bénite

75010

A.P.H. Paris, Hopital Saint Louis ( Site 2107), Paris

78229

Mays Cancer Center ( Site 2025), San Antonio

80045

University of Colorado, Anschutz Cancer Pavilion ( Site 2012), Aurora

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 2302), Napoli

90025

The Angeles Clinic and Research Institute ( Site 2009), Los Angeles

90095

UCLA Hematology & Oncology ( Site 2004), Los Angeles

90404

Providence Saint John's Health Center ( Site 2010), Santa Monica

94805

Gustave Roussy ( Site 2101), Villejuif

97239

Oregon Health & Science University ( Site 2013), Portland

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2261), Bogotá

760032

Fundación Valle del Lili ( Site 2265), Santiago de Cali

1720430

IC La Serena Research ( Site 2254), La Serena

1834111

HaEmek Medical Center ( Site 2703), Afula

3109601

Rambam Health Care Campus-Oncology ( Site 2704), Haifa

4810218

CIDO SpA-Oncology ( Site 2256), Temuco

4941492

Rabin Medical Center-Oncology ( Site 2705), Petah Tikva

5265601

Chaim Sheba Medical Center ( Site 2701), Ramat Gan

7500921

FALP-UIDO ( Site 2251), Santiago

7500994

Oncovida ( Site 2257), Santiago

8420383

Bradfordhill ( Site 2252), Santiago

9112001

Hadassah Ein Karem Jerusalem ( Site 2702), Jerusalem

C1430EGF

Clinica Adventista Belgrano-Oncology ( Site 2242), Caba.

1426ANZ

Instituto Alexander Fleming-Alexander Fleming ( Site 2243), Buenos Aires

C1187AAN

Sanatorio Finochietto ( Site 2245), Buenos Aires

115 26

"General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 2212)", Athens

570 01

European Interbalkan Medical Center-Oncology Department ( Site 2211), Thessaloniki

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2233), Warsaw

80-952

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2231), Gdansk

0002

Steve Biko Academic Hospital-Medical Oncology ( Site 2862), Pretoria

0181

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861), Pretoria

08036

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2801), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY