Clinical trial

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

Name

CA224-083

Description

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

Trial arms

Trial start

2021-12-09

Estimated PCD

2023-07-26

Trial end

2023-07-26

Status

Completed

Phase

Early phase I

Treatment

Relatlimab

Specified dose on specified days

Arms:

Part 1: Dose Escalation Phase

Other names:

BMS-986016

Ipilimumab

Specified dose on specified days

Arms:

Part 1: Dose Escalation Phase

Size

Primary endpoint

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)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

Updated at

2023-09-29

1 organization

2 products

1 indication

Product

Indication

Organization

Product