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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Melanoma

Treatments: Biological: Nivolumab; Biological: Nivolumab + Relatlimab Fixed Dose Combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT05002569

2021-001641-13 (EudraCT Number)

CA224-098

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,050 participants in 2 patient groups

Arm A: Nivolumab Plus Relatlimab

Experimental group

Description:

Combination

Treatment:

Biological: Nivolumab + Relatlimab Fixed Dose Combination

Arm B: Nivolumab

Experimental group

Description:

Monotherapy

Treatment:

Biological: Nivolumab