West Cancer Center

MELANOMA: ADJUVANT: STAGE III: PD1+/- LAG3: RELATIVITY-098

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Title

BMS CA224-098 MELANOMA ADJUVANT LAG3

Study Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Site Link

NCT05002569

Malignancy

Melanoma

Stage

Stage 3

Disease Setting

Adjuvant/Post-surgical

Line Of Therapy

Adjuvant

Investigational Agent

Relatlimab, Nivolumab

Drug Class

LAG3 inhibitor, PD-1 inhibitor

David Portnoy

Sponsor

Bristol Myers Squibb

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Must have been diagnosed with either Stage IIIA (>1mm tumor in lymph node), Stage IIIB, Stage IIIC, Stage IIID, or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected with negative margins
ECOG PS 0-1
Resection must have been performed within 12 weeks prior to randomization
Tumor tissue available
No history of uveal melanoma
No untreated CNS metastases

Objective

Primary
- RFS
Secondary
- DMFS
- OS
- Safety
- PFS2

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes