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Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)

Primary Purpose

Melanoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ipilimumab

Nivolumab

Placebo matching Ipilimumab

Placebo matching Nivolumab

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
Completely removed melanoma by surgery performed within 12 weeks of randomization
Stage IIIb/C or Stage IV before complete resection
No previous anti-cancer treatment

Exclusion Criteria:

Ocular or uveal melanoma
History of carcinomatosis meningitis
History of auto-immune disease
Treatment directed against the resected melanoma that is administrated after the surgery

Other protocol-defined inclusion/exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ipilimumab and Placebo matching Nivolumab

Nivolumab and Placebo matching Ipilimumab

Arm Description

Outcomes

Primary Outcome Measures

Recurrence-free Survival (RFS)

RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

Secondary Outcome Measures

Overall Survival (OS)

OS is defined as as the time between the date of randomization and the date of death.

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths

the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Recurrence-free Survival by PD-L1 Expression

Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

Health Related Quality of Life (HRQoL) Evaluation

HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.

Full Information

NCT ID

NCT02388906

First Posted

March 10, 2015

Last Updated

October 19, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02388906

Brief Title

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

Acronym

CheckMate 238

Official Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 19, 2015 (Actual)

Primary Completion Date

November 26, 2018 (Actual)

Study Completion Date

October 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

906 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ipilimumab and Placebo matching Nivolumab

Arm Type

Experimental

Arm Title

Nivolumab and Placebo matching Ipilimumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Intervention Description

Specified dose on specified days

Intervention Type

Other

Intervention Name(s)

Placebo matching Ipilimumab

Intervention Description

Specified dose on specified days

Intervention Type

Other

Intervention Name(s)

Placebo matching Nivolumab

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Recurrence-free Survival (RFS)

Description

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as as the time between the date of randomization and the date of death.

Time Frame

up to 60 months

Title

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events

Description

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

Time Frame

reported between first dose and 30 days after last dose of study therapy

Title

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events

Description

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

Time Frame

reported between the first dose and 30 days after last dose of study therapy

Title

the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths

Description

the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths

Time Frame

reported between first dose and 30 to 100 days after last dose of study therapy

Title

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities

Description

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Time Frame

reported after first dose and within 30 days of last dose of the study therapy

Title

Recurrence-free Survival by PD-L1 Expression

Description

Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

Time Frame

up to 36 months

Title

Health Related Quality of Life (HRQoL) Evaluation

Description

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age Completely removed melanoma by surgery performed within 12 weeks of randomization Stage IIIb/C or Stage IV before complete resection No previous anti-cancer treatment Exclusion Criteria: Ocular or uveal melanoma History of carcinomatosis meningitis History of auto-immune disease Treatment directed against the resected melanoma that is administrated after the surgery Other protocol-defined inclusion/exclusion criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0036

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Local Institution - 0117

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0698

Country

United States

Facility Name

Local Institution - 0189

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Local Institution - 0021

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

Local Institution - 0006

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Local Institution - 0010

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Local Institution - 0004

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Local Institution - 0012

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Local Institution - 0019

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Local Institution - 0030

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Local Institution - 0032

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution - 0016

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Local Institution - 0106

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Local Institution - 0013

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0170

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0171

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0015

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5869

Country

United States

Facility Name

Local Institution - 0002

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Local Institution - 0017

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 0123

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Local Institution - 0095

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Local Institution - 0024

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Local Institution - 0033

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0003

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Local Institution - 0025

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Local Institution - 0157

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Local Institution - 0031

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Local Institution - 0029

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Local Institution - 0022

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Local Institution - 0001

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Local Institution - 0026

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Local Institution - 0014

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203-1624

Country

United States

Facility Name

Local Institution - 0005

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Local Institution - 0027

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Local Institution - 0126

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 0142

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution - 0140

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution - 0079

City

Gateshead

State/Province

New South Wales

ZIP/Postal Code

2290

Country

Australia

Facility Name

Local Institution - 0080

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Local Institution - 0078

City

Wollstonecraft

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution - 0082

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

Local Institution - 0083

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Local Institution - 0084

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution - 0075

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution - 0077

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Local Institution - 0085

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Local Institution - 0081

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

Local Institution - 0169

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Local Institution - 0168

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Local Institution - 0038

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Local Institution - 0040

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution - 0037

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution - 0039

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution - 0051

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution - 0074

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Local Institution - 0094

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0105

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Local Institution - 0046

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Local Institution - 0101

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution - 0102

City

Ostrava-Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Local Institution - 0099

City

Praha 1

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Local Institution - 0100

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Local Institution - 0047

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Local Institution - 0048

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

Local Institution - 0138

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution - 0135

City

Marseille Cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Local Institution - 0134

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Local Institution - 0136

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Local Institution - 0133

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Local Institution - 0137

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution - 0086

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

Local Institution - 0087

City

Neo Faliro

ZIP/Postal Code

18547

Country

Greece

Facility Name

Local Institution - 0163

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Local Institution - 0166

City

Dublin 7

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0063

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0108

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0064

City

Galway

Country

Ireland

Facility Name

Local Institution - 0112

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Local Institution - 0116

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

Local Institution - 0115

City

Meldola (FC)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0113

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0107

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0111

City

Padova

ZIP/Postal Code

Padova

Country

Italy

Facility Name

Local Institution - 0114

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution - 0110

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution - 0179

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Local Institution - 0161

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

8128582

Country

Japan

Facility Name

Local Institution - 0174

City

Tsukuba-shi

State/Province

Ibaraki

ZIP/Postal Code

3058576

Country

Japan

Facility Name

Local Institution - 0162

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

8608556

Country

Japan

Facility Name

Local Institution - 0160

City

Matsumoto-shi

State/Province

Nagano

ZIP/Postal Code

3908621

Country

Japan

Facility Name

Local Institution - 0175

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

9518566

Country

Japan

Facility Name

Local Institution - 0176

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

5400006

Country

Japan

Facility Name

Local Institution - 0159

City

Sunto-gun

State/Province

Shizuoka

ZIP/Postal Code

4118777

Country

Japan

Facility Name

Local Institution - 0158

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

1040045

Country

Japan

Facility Name

Local Institution - 0180

City

Chuo-shi

State/Province

Yamanashi

ZIP/Postal Code

4093898

Country

Japan

Facility Name

Local Institution - 0129

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Local Institution - 0127

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Local Institution - 0144

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Local Institution - 0128

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Local Institution - 0042

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Local Institution - 0045

City

Groningen

ZIP/Postal Code

9714 CZ

Country

Netherlands

Facility Name

Local Institution - 0043

City

Nijmegen

ZIP/Postal Code

6525GA

Country

Netherlands

Facility Name

Local Institution - 0041

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

Local Institution - 0098

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Local Institution - 0109

City

Oslo

ZIP/Postal Code

3100

Country

Norway

Facility Name

Local Institution - 0150

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Local Institution - 0149

City

Krakow

ZIP/Postal Code

31-115

Country

Poland

Facility Name

Local Institution - 0152

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution - 0156

City

Craiova

ZIP/Postal Code

200542

Country

Romania

Facility Name

Local Institution - 0153

City

Romania

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0148

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Local Institution - 0145

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0075

Country

South Africa

Facility Name

Local Institution - 0147

City

Saxonwold, Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Local Institution - 0181

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Local Institution - 0146

City

Kraaifontein

State/Province

Western Cape

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Local Institution - 0120

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 0119

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution - 0121

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Local Institution - 0122

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Local Institution - 0050

City

Gothenberg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Local Institution - 0096

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Local Institution - 0167

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Local Institution - 0131

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Local Institution - 0132

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Local Institution - 0130

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Local Institution - 0057

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Local Institution - 0052

City

Swansea

State/Province

Carmarthenshire

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Facility Name

Local Institution - 0165

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution - 0054

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0056

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Local Institution - 0177

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2JR

Country

United Kingdom

Facility Name

Local Institution - 0055

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Local Institution - 0060

City

Newcastle Upon Tyne

State/Province

Tyne And Wear

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Local Institution - 0097

City

Leicester

ZIP/Postal Code

LE15WW

Country

United Kingdom

Facility Name

Local Institution - 0053

City

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35964471

Citation

Larkin J, Weber J, Del Vecchio M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, De la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Mandala M. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. Eur J Cancer. 2022 Sep;173:285-296. doi: 10.1016/j.ejca.2022.06.041. Epub 2022 Aug 11.

Results Reference

derived

PubMed Identifier

34663559

Citation

Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.

Results Reference

derived

PubMed Identifier

34452930

Citation

Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8):e003188. doi: 10.1136/jitc-2021-003188. Erratum In: J Immunother Cancer. 2021 Nov;9(11):

Results Reference

derived

PubMed Identifier

32961119

Citation

Ascierto PA, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Erratum In: Lancet Oncol. 2021 Oct;22(10):e428.

Results Reference

derived

PubMed Identifier

28891423

Citation

Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

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Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)

Melanoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial