Clinical trial · Interventional
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to meet protocol objectives
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Biological | Nivolumab | ALIAS |
| Nivolumab + Relatlimab Fixed Dose Combination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Nivolumab Plus Relatlimab
- description
- Combination
- interventionNames
- Biological: Nivolumab + Relatlimab Fixed Dose Combination
- type
- EXPERIMENTAL
- label
- Arm B: Nivolumab
- description
- Monotherapy
- interventionNames
- Biological: Nivolumab
Primary outcomes (1)
- measure
- Recurrence Free Survival (RFS)
- timeFrame
- Approximately 27.5 Months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLong GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med. 2025 Dec;31(12):4301-4309. doi: 10.1038/s41591-025-04032-8. Epub 2025 Oct 18. PMID 41109920