A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
- Conditions
- Melanoma
- Interventions
- Biological: Nivolumab + Relatlimab Fixed Dose Combination
- Registration Number
- NCT05002569
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Nivolumab Nivolumab Monotherapy Arm A: Nivolumab Plus Relatlimab Nivolumab + Relatlimab Fixed Dose Combination Combination
- Primary Outcome Measures
Name Time Method Recurrence-Free Survival (RFS) time per Investigator assessment Approximately 52 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 90 months Distant Metastasis-Free Survival (DMFS) time per Investigator assessment Approximately 90 months Incidence of Serious Adverse Events (SAEs) 30 days from participant's last dose Severity of SAEs 30 days from participant's last dose Severity of IMAEs 135 days from participant's last dose Severity of drug related AEs 30 days from participant's last dose Severity of AEs 30 days from participant's last dose Incidence of Adverse Events (AEs) 30 days from participant's last dose Incidence of AEs leading to discontinuation (DC) 30 days from participant's last dose Severity of AEs leading to DC 30 days from participant's last dose Incidence of immune-mediated AEs (IMAEs) 135 days from participant's last dose Incidence of clinically significant changes in clinical laboratory values: Hematology tests 30 days from participant's last dose Incidence of clinically significant changes in clinical laboratory values: Chemistry tests 30 days from participant's last dose Progression-Free Survival 2 (PFS2) Approximately 52 months Incidence of drug related AEs 30 days from participant's last dose Incidence of deaths 30 days from participant's last dose
Trial Locations
- Locations (184)
Saint John's Cancer Institute
🇺🇸Santa Monica, California, United States
Washington University School Of Medicine
🇺🇸Miami, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
🇺🇸Tampa, Florida, United States
Dana-Farber Cancer Institute-Melanoma
🇺🇸Boston, Massachusetts, United States
Icahn School Of Medicine At Mount Sinai
🇺🇸New York, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
🇺🇸Columbus, Ohio, United States
Local Institution - 0001
🇦🇷Caba, Distrito Federal, Argentina
Local Institution - 0254
🇦🇺Tiwi, Northern Territory, Australia
Local Institution - 0221
🇨🇳Hefei, Anhui, China
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