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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05002569
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Melanoma Biological: Nivolumab Biological: Nivolumab + Relatlimab Fixed Dose Combination Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : February 15, 2026
Estimated Study Completion Date : November 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Nivolumab Plus Relatlimab
Combination
 Biological: Nivolumab + Relatlimab Fixed Dose Combination
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag
Experimental: Arm B: Nivolumab
Monotherapy
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS) time per Investigator assessment [ Time Frame: Approximately 52 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 90 months ]
  2. Distant Metastasis-Free Survival (DMFS) time per Investigator assessment [ Time Frame: Approximately 90 months ]
  3. Incidence of Adverse Events (AEs) [ Time Frame: 30 days from participant's last dose ]
  4. Severity of AEs [ Time Frame: 30 days from participant's last dose ]
  5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: 30 days from participant's last dose ]
  6. Severity of SAEs [ Time Frame: 30 days from participant's last dose ]
  7. Incidence of AEs leading to discontinuation (DC) [ Time Frame: 30 days from participant's last dose ]
  8. Severity of AEs leading to DC [ Time Frame: 30 days from participant's last dose ]
  9. Incidence of immune-mediated AEs (IMAEs) [ Time Frame: 135 days from participant's last dose ]
  10. Severity of IMAEs [ Time Frame: 135 days from participant's last dose ]
  11. Incidence of drug related AEs [ Time Frame: 30 days from participant's last dose ]
  12. Severity of drug related AEs [ Time Frame: 30 days from participant's last dose ]
  13. Incidence of deaths [ Time Frame: 30 days from participant's last dose ]
  14. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: 30 days from participant's last dose ]
  15. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: 30 days from participant's last dose ]
  16. Progression-Free Survival 2 (PFS2) [ Time Frame: Approximately 52 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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 < 18 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05002569


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05002569    
Other Study ID Numbers: CA224-098
2021-001641-13 ( EudraCT Number )
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: June 2023

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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:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action