Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma

Phase 1

• Conditions: participants with completely resected Stage III or Stage IV melanoma; MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001641-13-DK
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

- All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except ocular melanoma, regardless of primary site of disease, will be allowed.
- 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 obtained from surgical specimen or biopsy during resection collected within 90 days prior to randomization, with an associated pathology report, must be submitted to the central laboratory (preferably prior to randomization).
- Participant must be = 12 years of age inclusive at the time of signing the informed consent. Except: Where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is = 18 years of age.
- Participants = 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status = 1. Adolescent participants between 12 and <18 years of age must have a Lansky/Karnofsky performance score = 80%.

Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 972
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 365

Exclusion Criteria

- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted (such as, but not limited to, anti-programmed death-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways).
- Prior treatment with LAG-3 targeted agents.
- Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
- Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a history of myocarditis, regardless of etiology.
- Prior treatment with BRAF/MEK targeted agents.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified