A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT05002569 Recruiting August 12, 2021 September 22, 2022

study description
Brief Summary

The purpose of this study is to assess nivolumab plus relatlimab 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: Nivolumab + Relatlimab 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 Nivolumab Plus Relatlimab 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: Nivolumab Plus Relatlimab
Combination
Biological: Nivolumab + Relatlimab 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 59 months ]
Secondary Outcome Measures: 1. Progression-Free Survival 2 (PFS2) [ Time Frame: Until second recurrence, up to 5 years ]
2. Overall Survival (OS) [ Time Frame: Until death, up to 96 months ]
3. Distant Metastasis-Free Survival (DMFS) time per Investigator assessment [ Time Frame: Until distant progression, up to 96 months ]
4. Incidence of Adverse Events (AEs) [ Time Frame: 30 days from participant's last dose ]
5. Severity of AEs [ Time Frame: 30 days from participant's last dose ]
6. Incidence of Serious Adverse Events (SAEs) [ Time Frame: 30 days from participant's last dose ]
7. Severity of SAEs [ Time Frame: 30 days from participant's last dose ]
8. Incidence of AEs leading to discontinuation (DC) [ Time Frame: 30 days from participant's last dose ]
9. Severity of AEs leading to DC [ Time Frame: 30 days from participant's last dose ]
10. Incidence of immune-mediated AEs (IMAEs) [ Time Frame: 135 days from participant's last dose ]
11. Severity of IMAEs [ Time Frame: 135 days from participant's last dose ]
12. Incidence of drug related AEs [ Time Frame: 30 days from participant's last dose ]
13. Severity of drug related AEs [ Time Frame: 30 days from participant's last dose ]
14. Incidence of deaths [ Time Frame: 30 days from participant's last dose ]
15. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: 30 days from participant's last dose ]
16. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: 30 days from participant's last dose ]
17. Duration of Treatment on next line therapies [ Time Frame: Until end of next-line therapy, up to 5 years ]

Eligibility Criteria
Ages Eligible for Study: 12 Years and older (Child, 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 ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and 17 years of age must have a Lansky/Karnofsky performance score ≥ 80% Complete resection must be performed within 90 days 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 ocular 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 within 4 weeks prior to screening History of myocarditis, regardless of etiology. 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
Italy Local Institution - 0119 Napoli
Italy Local Institution - 0123 Milano
Italy Local Institution - 0115 Milan
Italy Local Institution - 0268 Milan
Italy Local Institution - 0120 Padova
Italy Local Institution - 0122 Perugia
Italy Local Institution - 0121 Siena
United States, Alabama Local Institution Birmingham
United States, Arkansas Highlands Oncology Group-Research Department Springdale
United States, California The Angeles Clinic And Research Institute. 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 Georgetown University Medical Center Lombardi Cancer Center Washington
United States, Florida Local Institution Miami
United States, Florida University of Miami Hospital and Clinics, Sylvester Cancer Center Miami
United States, Florida Sacred Heart Medical Group Pensacola
United States, Georgia Winship Cancer Institute of Emory University Atlanta
United States, Georgia Northside Hospital Atlanta
United States, Illinois Northwestern Memorial Hospital Chicago
United States, Illinois Illinois Cancercare, PC 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, Michigan University Of Michigan Ann Arbor
United States, Michigan Local Institution Grand Rapids
United States, Minnesota Virginia Piper Cancer Institute Minneapolis
United States, New Jersey John Theurer Cancer Center Hackensack
United States, New Jersey Atlantic Health System Morristown Medical Center Morristown
United States, New York NYU Langone Health-Perlmutter Cancer Center 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 Cleveland Clinic-Taussig Cancer Center Cleveland
United States, Pennsylvania Lehigh Valley Health Network Allentown
United States, Pennsylvania UPMC Hillman Cancer Center Pittsburgh
United States, South Carolina Medical University Of South Carolina Charleston
United States, Tennessee The West Clinic Germantown
United States, Tennessee Vanderbilt-Ingram Cancer Center Nashville
United States, Texas Texas Oncology-Central Austin Cancer Center Austin
United States, Texas Texas Oncology Sammons Cancer Center Dallas
United States, Texas University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology Houston
United States, Virginia Inova Schar Cancer Institute Fairfax
Argentina, Cordoba Local Institution - 0004 Córdoba
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
Australia, New South Wales Local Institution - 0030 Waratah
Australia, New South Wales Local Institution - 0252 Westmead
Australia, New South Wales Local Institution - 0032 Wollstonecraft
Australia, Northern Territory Local Institution - 0254 Tiwi
Australia, Queensland Local Institution - 0028 Brisbane
Australia, Queensland Local Institution - 0027 Southport
Australia, South Australia Local Institution - 0250 Woodville
Australia, Victoria Local Institution Ballarat Central
Australia, Victoria Local Institution - 0035 Ballarat
Australia, Victoria Local Institution - 0253 Heidelberg
Australia, Victoria Local Institution - 0031 Melbourne
Australia, Western Australia Local Institution - 0251 Murdoch
Australia, Western Australia Local Institution - 0029 Perth
Austria, Steiermark Local Institution - 0082 Graz
Austria Local Institution - 0086 Salzburg
Austria Local Institution - 0084 Vienna
Belgium Local Institution - 0110 Brussels
Belgium Local Institution - 0105 Brussels
Belgium Local Institution - 0109 Liège
Belgium Local Institution - 0106 Wilrijk
Brazil, Bahia Local Institution - 0071 Salvador
Brazil, Ceara Local Institution - 0072 Fortaleza
Brazil, Espirito Santo Local Institution - 0068 Vitória
Brazil, Minas Gerais Local Institution - 0047 Belo Horizonte
Brazil, Rio Grande Do Sul Local Institution - 0056 Ijui
Brazil, RIO Grande DO SUL Local Institution - 0257 Porto Alegre
Brazil, RIO Grande DO SUL Local Institution - 0049 Porto Alegre
Brazil, RIO Grande DO SUL Local Institution - 0048 Santa Cruz do Sul
Brazil, SAO Paulo Local Institution - 0070 Barretos
Brazil Local Institution - 0058 Rio de Janeiro
Canada, British Columbia Local Institution Vancouver
Canada, Nova Scotia Local Institution - 0197 Halifax
Canada, Ontario Local Institution Toronto
Canada, Quebec Local Institution - 0158 Montreal
Canada, Quebec Local Institution - 0159 Montréal
Canada, Quebec Local Institution - 0160 Quebec City
Canada, Quebec Local Institution Sherbrooke
Canada Local Institution - 0155 Edmonton
Chile, Metropolitana Local Institution - 0013 Santiago
Chile, Metropolitana Local Institution - 0006 Santiago
Chile, Metropolitana Local Institution - 0014 Santiago
China, Beijing Local Institution - 0259 Beijing
China, Beijing Local Institution - 0261 Beijing
China, Beijing Local Institution - 0214 Beijing
China, Chongqing Local Institution - 0241 Chongqing
China, Fujian Local Institution - 0245 Fuzhou City
China, Guangdong Local Institution - 0217 Guangzhou
China, Henan Local Institution - 0226 Zhengzhou Shi
China, Hubei Local Institution - 0237 Wuhan
China, Hunan Local Institution - 0234 Changsha Shi
China, Jiangsu Local Institution - 0215 Nanjing
China, Jilin Local Institution - 0219 Changchun
China, Liaoning Local Institution - 0242 Shenyang
China, Sichuan Local Institution Chengdu
China, Tianjin Local Institution Tianjin
China, Xinjiang Local Institution Urumqi
China, Yunnan Local Institution - 0222 Kunming
China, Zhejiang Local Institution Hangzhou
China Local Institution - 0244 Taiyuan
Czechia Local Institution - 0156 Brno
Czechia Local Institution - 0091 Hradec Kralove
Czechia Local Institution - 0026 Ostrava
Czechia Local Institution - 0062 Prague
Denmark Local Institution - 0022 Aalborg
Denmark Local Institution - 0018 Copenhagen
Denmark Local Institution - 0020 Odense
Finland Local Institution - 0007 Helsinki
Finland Local Institution - 0019 Tampere
Finland Local Institution - 0015 Turku
France, Val-de-Marne Local Institution - 0040 Villejuif
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
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 Local Institution - 0080 Wuerzburg
Greece Local Institution - 0114 Athens
Greece Local Institution - 0113 Neo Faliro
Greece Local Institution - 0112 Thessaloniki
Israel Local Institution - 0116 Afula
Israel Local Institution - 0118 Jerusalem
Israel Local Institution - 0199 Ramag Gan
Israel Local Institution - 0117 Ramat Gan
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, Akershus Local Institution - 0009 Lørenskog
Norway Local Institution - 0017 Oslo
Norway Local Institution - 0023 Stavanger
Portugal Local Institution - 0249 Coimbra
Portugal Local Institution Lisboa
Portugal Local Institution Lisbon
Portugal Local Institution Porto
Romania Local Institution Brasov
Romania Local Institution - 0065 Cluj
Romania Local Institution - 0066 Craiova
Romania Local Institution - 0064 Floresti/ Cluj
Romania Local Institution Iasi
Spain Local Institution - 0188 Badajoz
Spain Local Institution - 0201 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 - 0010 Gothenburg
Sweden Local Institution - 0011 Lund
Sweden Local Institution - 0012 Solna
Switzerland Local Institution - 0085 Basel
Switzerland Kantonsspital Graubünden-Medizin Chur
Switzerland Local Institution - 0090 Zürich
United Kingdom, Lanarkshire Local Institution - 0187 Glasgow
United Kingdom, Nottinghamshire Local Institution - 0101 Nottingham
United Kingdom Local Institution Bristol
United Kingdom Local Institution - 0232 Oxford
United Kingdom Local Institution Southampton
United Kingdom Local Institution Swansea
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05002569     
Other Study ID Numbers : CA224-098, 2021-001641-13
First Posted : August 12, 2021
Last Update Posted : September 22, 2022
Last Verified : September 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