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)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 26, 2020

Primary Completion Date

August 25, 2025

Study Completion Date

August 25, 2025

Conditions
Melanoma
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

Trial Locations (36)

1011

CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602), Lausanne

1211

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

2065

Melanoma Institute Australia ( Site 1402), Wollstonecraft

2298

Calvary Mater Newcastle-Medical Oncology ( Site 1404), Waratah

4215

Tasman Oncology Research Pty Ltd ( Site 1403), Southport

6055

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

6150

Fiona Stanley Hospital ( Site 1401), Murdoch

8058

Universitaetsspital Zuerich ( Site 1601), Zuerich Flughafen

10016

NYU Clinical Cancer Center ( Site 1002), New York

13005

Hopital La Timone ( Site 1103), Marseille

19104

University of Pennsylvania Abramson Cancer Center ( Site 1008), Philadelphia

20133

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

20141

Istituto Europeo di Oncologia ( Site 1301), Milan

21287

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

22031

Inova Schar Cancer Institute ( Site 1011), Fairfax

27710

Duke Cancer Institute ( Site 1005), Durham

31059

Institut Claudius Regaud ( Site 1105), Toulouse

33075

Hopital Saint Andre ( Site 1108), Bordeaux

35128

Istituto Oncologico Veneto IRCCS ( Site 1355), Padua

38138

West Cancer Center - East Campus ( Site 1014), Germantown

43221

Martha Morehouse Tower ( Site 1020), Columbus

53100

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

69495

Centre Hospitalier Lyon Sud ( Site 1102), Pierre-Bénite

75010

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

77030

University of Texas MD Anderson Cancer Center ( Site 1006), Houston

80045

University of Colorado, Anschutz Cancer Pavilion ( Site 1012), Aurora

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 1302), Napoli

90025

The Angeles Clinic and Research Institute ( Site 1009), Los Angeles

90095

UCLA Hematology & Oncology ( Site 1004), Los Angeles

90404

Providence Saint John's Health Center ( Site 1010), Santa Monica

94805

Gustave Roussy ( Site 1101), Villejuif

97239

Oregon Health & Science University ( Site 1013), Portland

1834111

HaEmek Medical Center ( Site 1703), Afula

3109601

Rambam Health Care Campus-Oncology ( Site 1704), Haifa

5265601

Chaim Sheba Medical Center ( Site 1701), Ramat Gan

9112001

Hadassah Ein Karem Jerusalem ( Site 1702), Jerusalem

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04305041 - 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) | Biotech Hunter | Biotech Hunter