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A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma (RELATIVITY-098)

  • Clinicaltrials.gov identifier

    NCT05002569

  • Recruitment Status

    Recruiting

  • First Posted

    August 12, 2021

  • Last update posted

    May 13, 2022

Study Description

Brief summary:

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

  • Condition or Disease:Melanoma
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Relatlimab + Nivolumab Fixed Dose Combination
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1050 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
  • Actual Study Start Date: October 2021
  • Estimated Primary Completion Date: December 2025
  • Estimated Study Completion Date: December 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Arm B: Nivolumab
Monotherapy
Biological: Nivolumab
Specified dose on specified days
Experimental: Arm A: Relatlimab + Nivolumab
Combination
Biological: Relatlimab + Nivolumab Fixed Dose Combination
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Recurrence-Free Survival (RFS) time per Investigator assessment [ Time Frame: Until recurrence, up to 56 months ]
  • Secondary Outcome Measures: 1. Distant Metastasis-Free Survival (DMFS) time per Investigator assessment [ Time Frame: Until distant progression, up to 56 months ]
  • 2. Overall Survival (OS) [ Time Frame: Until death, up to 72 months ]
  • 3. Incidence of Adverse Events (AEs) [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 4. Severity of AEs [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 6. Severity of SAEs [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 7. Incidence of AEs leading to discontinuation (DC) [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 8. Severity of AEs leading to DC [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 9. Incidence of immune-mediated AEs (IMAEs) [ Time Frame: 135 days from participant's last dose, up to 56 months ]
  • 10. Severity of IMAEs [ Time Frame: 135 days from participant's last dose, up to 56 months ]
  • 11. Incidence of drug related AEs [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 12. Severity of drug related AEs [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 13. Incidence of deaths [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 14. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 15. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: 30 days from participant's last dose, up to 56 months ]
  • 16. Duration of Treatment on next line therapies [ Time Frame: Until end of next-line therapy, up to 4 years ]
  • 17. Progression-Free Survival 2 (PFS2) [ Time Frame: Until second recurrence, up to 4 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Complete resection must be performed within 12 weeks prior to randomization All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization Tumor tissue must be provided for biomarker analyses Exclusion Criteria: History of uveal melanoma Untreated/unresected CNS metastases or leptomeningeal metastases Active, known, or suspected autoimmune disease Participants with serious or uncontrolled medical disorder Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT # and Site #.

Locations

United States, Alabama
Local Institution
Birmingham

United States, Arkansas
Highlands Oncology Group-Research Department
Springdale

United States, California
Local Institution
Los Angeles

United States, California
Local Institution
Palo Alto

United States, California
San Francisco Oncology Associates
San Francisco

United States, Colorado
Local Institution
Aurora

United States, District of Columbia
Local Institution
Washington

United States, Florida
Local Institution
Miami

United States, Florida
Local Institution
Miami

United States, Florida
Sacred Heart Medical Group
Pensacola

United States, Florida
Local Institution
Tampa

United States, Georgia
Winship Cancer Institute, Emory University
Atlanta

United States, Georgia
Northside Hospital
Atlanta

United States, Illinois
Local Institution
Chicago

United States, Illinois
Local Institution
Peoria

United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne

United States, Iowa
Local Institution
Iowa City

United States, Kansas
Local Institution
Kansas City

United States, Massachusetts
Local Institution
Boston

United States, Michigan
Local Institution
Ann Arbor

United States, Michigan
Local Institution
Grand Rapids

United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis

United States, New Jersey
Local Institution
Hackensack

United States, New Jersey
Local Institution
Morristown

United States, New York
NYU Langone Health-Perlmutter Cancer Center
New York

United States, New York
Local Institution
New York

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, North Carolina
Levine Cancer Institute-Cutaneous Malignancies/Immunotherapy
Charlotte

United States, North Carolina
Duke Cancer Institute
Durham

United States, Ohio
Local Institution
Cleveland

United States, Ohio
Local Institution
Columbus

United States, Pennsylvania
Local Institution
Philadelphia

United States, Pennsylvania
Local Institution
Pittsburgh

United States, South Carolina
Local Institution
Charleston

United States, Tennessee
The West Clinic
Germantown

United States, Tennessee
Local Institution
Nashville

United States, Texas
Local Institution
Austin

United States, Texas
Local Institution
Dallas

United States, Texas
University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology
Houston

United States, Virginia
Local Institution
Fairfax

Argentina, Distrito Federal
Local Institution - 0001
Caba

Argentina, Distrito Federal
Local Institution - 0005
Ciudad Autónoma de Buenos Aires

Argentina, Distrito Federal
Local Institution - 0002
Ciudad de Buenos Aires

Argentina
Local Institution - 0003
Buenos Aires

Argentina
Local Institution
Cordoba

Australia, New South Wales
Local Institution
Waratah

Australia, New South Wales
Local Institution
Westmead

Australia, New South Wales
Local Institution - 0032
Wollstonecraft

Australia, Northern Territory
Local Institution
Tiwi

Australia, Queensland
Local Institution - 0028
Brisbane

Australia, Queensland
Local Institution - 0027
Southport

Australia, South Australia
Local Institution
Woodville South

Australia, Victoria
Local Institution
Ballarat Central

Australia, Victoria
Local Institution
Ballarat Central

Australia, Victoria
Local Institution
Heidelberg

Australia, Victoria
Local Institution - 0031
Melbourne

Australia, Western Australia
Local Institution
Murdoch

Australia, Western Australia
Local Institution
Nedlands

Austria
Local Institution - 0082
Graz

Austria
Local Institution - 0086
Salzburg

Austria
Local Institution - 0084
Vienna

Belgium
Local Institution
Brussels

Belgium
Local Institution - 0105
Brussels

Belgium
Local Institution - 0109
Liège

Belgium
Local Institution
Wilrijk

Brazil, Bahia
Local Institution
Salvador

Brazil, Ceara
Local Institution
Fortaleza

Brazil, Espirito Santo
Local Institution
Vitória

Brazil, Minas Gerais
Local Institution
BH

Brazil, RIO Grande DO SUL
Local Institution
Ijui

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution - 0048
Santa Cruz do Sul

Brazil, SAO Paulo
Local Institution
Barretos

Brazil
Local Institution
Rio de Janeiro

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Canada, Nova Scotia
Local Institution
Halifax

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Sherbrooke

Canada
Local Institution
Montréal

Canada
Local Institution
Quebec

Chile, Metropolitana
Local Institution - 0013
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution - 0006
Santiago

China, Beijing
Local Institution
Beijing

China, Guangdong
Local Institution
Guangzhou

China, Henan
Local Institution
Zhengzhou

China, Hubei
Local Institution
Wuhan Shi

China, Jiangsu
Local Institution
Nanjing

China, Sichuan
Local Institution
Chengdu

China, Tianjin
Local Institution
Tianjin

China, Xinjiang
Local Institution
Urumqi

China, Zhejiang
Local Institution
Hangzhou

Czechia
Local Institution - 0156
Brno

Czechia
Local Institution - 0091
Hradec Kralove

Czechia
Local Institution - 0026
Ostrava

Czechia
Local Institution - 0062
Prague

Denmark
Local Institution
Aalborg

Denmark
Local Institution
Aarhus N

Denmark
Local Institution
Herlev

Denmark
Local Institution - 0020
Odense

Finland
Local Institution - 0007
Helsinki

Finland
Local Institution
Tampere

Finland
Local Institution
Turku

France
Local Institution - 0043
Dijon

France
Local Institution - 0044
Marseille

France
Local Institution - 0039
Nantes

France
Local Institution - 0042
Paris

France
Local Institution - 0041
Pierre-Bénite

France
Local Institution - 0046
Toulouse

France
Local Institution - 0040
Villejuif

Germany
Local Institution - 0073
Buxtehude

Germany
Local Institution - 0077
Dresden

Germany
Local Institution - 0074
Erlangen

Germany
Local Institution - 0131
Essen

Germany
Local Institution - 0081
Gera

Germany
Local Institution - 0079
Hannover

Germany
Local Institution - 0075
Heidelberg

Germany
Local Institution - 0078
Lübeck

Germany
Local Institution - 0083
Minden

Germany
Local Institution - 0076
Munich

Germany
Local Institution - 0092
Tübingen

Germany
Universitaetsklinikum Wuerzburg-Department of Dermatology
Wuerzburg

Greece
Local Institution - 0114
Athens

Greece
Local Institution
Piraeus

Greece
Local Institution
Thessaloniki

Israel
Local Institution - 0116
Afula

Israel
Local Institution
Jerusalem

Israel
Local Institution - 0199
Ramag Gan

Israel
Local Institution - 0117
Ramat Gan

Italy
Local Institution - 0123
Milano

Italy
Local Institution - 0115
Milan

Italy
Local Institution - 0119
Napoli

Italy
Local Institution
Padova

Italy
Local Institution
Perugia

Italy
Local Institution - 0121
Siena

Mexico, Distrito Federal
Local Institution - 0100
Benito Juarez

Mexico, Jalisco
Local Institution - 0021
Zapopan

Mexico, Nuevo LEON
Local Institution - 0093
Mexico

Mexico
Local Institution - 0098
Oaxaca

Norway
Local Institution
Lorenskog

Norway
Local Institution - 0017
Oslo

Norway
Local Institution - 0023
Stavanger

Portugal
Local Institution
Coimbra

Portugal
Local Institution
Lisboa

Portugal
Local Institution
Lisbon

Portugal
Local Institution
Porto

Romania
Local Institution
Brasov

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Romania
Local Institution
Floresti/ Cluj

Romania
Local Institution
Iasi

Spain
Local Institution - 0188
Badajoz

Spain
Local Institution
Barcelona

Spain
Local Institution - 0153
Granada

Spain
Local Institution - 0150
Madrid

Spain
Local Institution - 0151
San Sebastian

Spain
Local Institution - 0152
València

Sweden
Local Institution
Goteborg

Sweden
Local Institution - 0011
Lund

Sweden
Local Institution
Stockholm

Switzerland
University Hospital Basel
Basel

Switzerland
Kantonsspital Graubünden-Medizin
Chur

Switzerland
Local Institution - 0090
Zürich

United Kingdom
Local Institution
Bristol

United Kingdom
Local Institution
Glasgow

United Kingdom
Local Institution
Nottingham

United Kingdom
Local Institution - 0232
Oxford

United Kingdom
Local Institution
Southampton

United Kingdom
Local Institution
Swansea

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05002569 History of Changes
  • Other Study ID Numbers: CA224-098, 2021-001641-13
  • First Posted: August 12, 2021 Key Record Dates
  • Last Update Posted: May 13, 2022
  • Last Verified: May 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Melanoma
    Relatlimab
    Nivolumab
    Opdivo
  • Additional relevant MeSH terms: Melanoma
    Neuroendocrine Tumors
    Neuroectodermal Tumors
    Neoplasms, Germ Cell and Embryonal
    Neoplasms by Histologic Type
    Neoplasms
    Neoplasms, Nerve Tissue
    Nevi and Melanomas