Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 3, 2021

Primary Completion Date

April 3, 2030

Study Completion Date

April 3, 2030

Conditions
Melanoma
Interventions
BIOLOGICAL

Pembrolizumab

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

Trial Locations (36)

1011

CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602), Lausanne

1211

Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603), Geneva

2065

Melanoma Institute Australia ( Site 4402), Wollstonecraft

2196

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863), Sandton

2298

Calvary Mater Newcastle ( Site 4404), Waratah

6055

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4865), Port Elizabeth

7570

Cape Town Oncology Trials ( Site 4864), Cape Town

8058

Universitaetsspital Zuerich ( Site 4601), Zurich

10016

NYU Clinical Cancer Center ( Site 4002), New York

13005

Hopital La Timone ( Site 4103), Marseille

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399), Milan

20141

Istituto Europeo di Oncologia ( Site 4301), Milan

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022), Baltimore

22031

Inova Schar Cancer Institute ( Site 4011), Fairfax

27710

Duke Cancer Institute ( Site 4005), Durham

28034

Hospital Universitario Ramón y Cajal ( Site 4802), Madrid

31059

Institut Claudius Regaud ( Site 4105), Toulouse

33075

CHU de Bordeaux- Hopital Saint Andre ( Site 4108), Bordeaux

35128

Istituto Oncologico Veneto IRCCS ( Site 4355), Padua

43221

Martha Morehouse Tower ( Site 4020), Columbus

53100

Policlinico Le Scotte - A.O. Senese ( Site 4377), Siena

69495

Centre Hospitalier Lyon Sud ( Site 4102), Pierre-Bénite

75010

A.P.H. Paris, Hopital Saint Louis ( Site 4107), Paris

80045

University of Colorado, Anschutz Cancer Pavilion ( Site 4012), Aurora

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 4302), Napoli

90025

The Angeles Clinic and Research Institute ( Site 4009), Los Angeles

90095

UCLA Hematology & Oncology ( Site 4004), Los Angeles

90404

Providence Saint John's Health Center ( Site 4010), Santa Monica

94805

Gustave Roussy ( Site 4101), Villejuif

1834111

HaEmek Medical Center ( Site 4703), Afula

3109601

Rambam Health Care Campus-Oncology ( Site 4704), Haifa

4941492

Rabin Medical Center-Oncology ( Site 4705), Petah Tikva

5265601

Chaim Sheba Medical Center ( Site 4701), Ramat Gan

9112001

Hadassah Ein Karem Jerusalem ( Site 4702), Jerusalem

0181

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861), Pretoria

08036

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 4801), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY