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

Bristol-Myers Squibb210 sites in 2 countries1,093 target enrollmentOctober 19, 2021

ConditionsMelanoma

InterventionsNivolumab Nivolumab + Relatlimab Fixed Dose Combination

DrugsNivolumab Nivolumab + Relatlimab Fixed Dose Combination

Overview

Phase: Phase 3
Intervention: Nivolumab
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 1093
Locations: 210
Primary Endpoint: Recurrence Free Survival (RFS)
Status: Terminated
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 19, 2021

End Date

April 2, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility 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 ≤
•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

Arms & Interventions

Arm B: Nivolumab

Monotherapy

Intervention: Nivolumab

Arm A: Nivolumab Plus Relatlimab

Combination

Intervention: Nivolumab + Relatlimab Fixed Dose Combination

Outcomes

Primary Outcomes

Recurrence Free Survival (RFS)

Time Frame: Approximately 27.5 Months

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

Secondary Outcomes

Overall Survival (OS)(Approximately 27.5 Months)
Distant Metastasis Free Survival (DMFS)(Approximately 27.5 Months)
Progression Free Survival on Next-Line Systemic Therapy (PFS2)(Approximately 27.5 Months)
Number of Participants With Safety Related Events(Approximately 27.5 Months)
Number of Participants With Select AEs(Approximately 27.5 Months)
Number of Participants With Endocrine Related Immune Mediated AEs(Approximately 27.5 Months)
Number of Participants With Non-endocrine Related Immune Mediated AEs(Approximately 27.5 Months)
Laboratory Abnormalities for Specific Thyroid Tests(Approximately 27.5 Months)