A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

387

Participants

Timeline

Start Date

April 4, 2016

Primary Completion Date

April 20, 2017

Study Completion Date

May 28, 2021

Conditions
Melanoma
Interventions
BIOLOGICAL

Nivolumab 3 mg/kg IV

Followed by Nivolumab monotherapy

BIOLOGICAL

Ipilimumab 1 mg/kg IV

Followed by Nivolumab monotherapy

BIOLOGICAL

Nivolumab 1 mg/kg IV

BIOLOGICAL

Ipilimumab 3 mg/kg IV

BIOLOGICAL

Nivolumab 6 mg/kg IV

A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.

Trial Locations (57)

2060

Local Institution, North Sydney

2298

Local Institution - 0045, Waratah

2730

Local Institution - 0065, Herlev

3004

Local Institution, Melbourne

4120

Local Institution, Greenslopes

5000

Local Institution - 0064, Odense

8200

Local Institution - 0063, Aarhus N

13385

Hopital De La Timone, Marseille

18103

Lehigh Valley Health Network, Allentown

20014

Local Institution, San Sabastian Gipuzkoa

20133

Local Institution - 0042, Milan

22908

University Of Virginia Health System, Charlottesville

24127

Local Institution - 0039, Bergamo

28007

Local Institution, Madrid

28034

Local Institution - 0027, Madrid

28204

Levine Cancer Institute, Charlotte

31059

Institut Claudius Regaud, Toulouse

33075

Hopital Saint Andre, Bordeaux

33612

H. Lee Moffitt Cancer Center, Tampa

35128

Istituto Oncologico Veneto IOV, Padua

44093

Hopital Hotel Dieu, Nantes

45147

Universitaetsklinikum Essen, Essen

46014

Local Institution, Valencia

53100

Local Institution - 0041, Siena

55432

Allina Health, Fridley

59037

Chru De Lille, Lille

63110

Washington University School Of Medicine, St Louis

69120

Universitaetsklinikum Heidelberg, Heidelberg

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

72076

Universitaetsklinikum Tuebingen, Tübingen

75475

Hopital Saint Louis, Paris

80045

University Of Colorado Cancer Center, Aurora

80131

Local Institution - 0040, Napoli

80337

Ludwig-Maximilians-Universitaet, München

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

94805

Local Institution - 0019, Villejuif

98039

Ospedale San Vincenzo, Taormina

98109

University of Washington - Seattle Cancer Care Alliance, Seattle

115478

Local Institution, Moscow

5262100

Local Institution, Ramat Gan

03756

Dartmouth-Hitchcock Medical Center, Lebanon

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

T6G 1Z2

Local Institution - 0007, Edmonton

M5G 2M9

Princess Margaret Cancer Centre, Toronto

G1R 2J6

CHU de Quebec - Universite Laval, Québec

1066 CX

Local Institution - 0052, Amsterdam

1081 HV

Local Institution, Amsterdam

9700RB

University Medical Center Groningen (Umcg), Groningen

80-214

Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote, Gdansk

31-115

Klinika Nowotworow Ukladowych i Uogolnionych, Krakow

02-781

Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Warsaw

08916

Local Institution, Badalona-barcelona

08036

Local Institution - 0024, Barcelona

M20 4XB

Local Institution, Manchester

OX3 7LJ

Local Institution, Oxford

GU2 7XX

Local Institution, Guildford

SW3 6JJ

Local Institution, London

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY