A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03978611

Enrollment

Registered

2019-06-07

Start date

2021-12-09

Completion date

2023-07-26

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.

Interventions

DRUGRelatlimab

Specified dose on specified days

DRUGIpilimumab

Specified dose on specified days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab * Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system * Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses * Eastern Cooperative Oncology Group (ECOG) 0-1

Exclusion criteria

* History of uveal melanoma * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome * Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events (AEs)	Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants with Serious Adverse Events (SAEs)	Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants With Adverse Events Including Dose Limiting Toxicity	Up to 28 days after last study drug dose (approximately up to 2 years)
Number of Participants with AEs resulting in Discontinuation	Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Death	Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Laboratory Abnormalities	Up to end of study (approximately 2.4 years)

Countries

Belgium, Canada, Germany, Italy, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026