Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

378

Participants

Timeline

Start Date

October 16, 2017

Primary Completion Date

October 13, 2020

Study Completion Date

December 31, 2025

Conditions
Uveal Melanoma
Interventions
BIOLOGICAL

IMCgp100

IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity

DRUG

Dacarbazine

Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity

BIOLOGICAL

Ipilimumab

Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments

BIOLOGICAL

Pembrolizumab

Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity

Trial Locations (57)

2010

Saint Vincents Hospital, Darlinghurst

2333

LUMC Medical Oncology, Leiden

3000

Peter MacCallum Cancer Center, Melbourne

5000

Central Adelaide Local Health Network, Royal Adelaide Hospital Cancer Center, Adelaide

6189

Centre Atoine Lacassagne, Nice

8091

University of Zurich Hospital, Zurich

8800

Uzhhorod Central City Clinical Hospital, Uzhhorod

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

15232

University of Pittsburgh Medical Center, Pittsburgh

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

19107

Thomas Jefferson University Hospital, Philadelphia

20133

Fondazione ICCRS, Milan

20246

University of Hamburg, Hamburg

27710

Duke University Health System, Durham

28046

Hospital Universitario La Paz, Madrid

30322

Winship Cancer Institute of Emory University, Atlanta

33136

University of Miami - Sylvester Comprehensive Cancer Center, Miami

41009

Hospital Universitario Virgen Macarena, Seville

43210

The Ohio State University, Columbus

46014

Hospital Universitario General de Valencia, Valencia

49102

Dnipropetrovsk State Medical Academy, Dnipro

50937

Universitaetsklinikum Koeln Dermatologie und Venerologie, Cologne

52242

University of Iowa, Iowa City

60611

Northwestern University, Chicago

60637

The University of Chicago Medicine, Chicago

63110

Washington University School of Medicine, St Louis

69120

Nationales Centrum für Tumorerkrankungen, Heidelberg

73104

University of Oklahoma, Oklahoma City

75005

Institut Curie, Paris

77030

Houston Methodist Cancer Center, Houston

80045

University of Colorado, Aurora

80131

"Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Melanoma, Immunoterapia Oncologica e Terapie Innovative", Napoli

80337

Klinik und Poliklinik für Dermatologie und Allergologie, Munich

90024

UCLA Medical Center, Los Angeles

90025

The Angeles Clinic and Research Institute, Los Angeles

94115

California Pacific Medical Center, San Francisco

94303

Byers Eye Institute, Stanford University, Palo Alto

97213

Portland Providence Medical Center, Portland

115478

Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology, Moscow

197758

Federal State Budget Institution National Medical Research Center of Oncology, Saint Petersburg

02114

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

Unknown

Institut Roi Albert II Cliniques Universitaires St-Luc, Brussels

Universite Catholique de Louvain Centre du Cancer, Medical Oncology, Brussels

University Hospital Essen, Essen

T6G 1Z2

Cross Cancer Institute, Edmonton

M5G 2M9

Princess Margaret Cancer Centre, Toronto

12200/12203

Charite - Campus Benjamin Franklin, Berlin

01307

Universitätsklinikum Carl Gustav Carus, Dresden

02-781

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Warsaw

08908

Institut Catala d'Oncologia (ICO) - L'Hospitalet, L'Hospitalet de Llobregat

02094

Kyiv Munitipal Hospital, Kyiv

HA6 2RN

Mount Vernon Cancer Centre, Northwood

CH63 4JY

The Clatterbridge Cancer Centre, Bebington

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Immunocore Ltd

INDUSTRY

NCT03070392 - Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma | Biotech Hunter | Biotech Hunter