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NCT03978611 Clinical Trial

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

Melanoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03978611
Other study ID # CA224-083
Secondary ID 2019-000132-25
Status Completed
Phase Phase 1
First received
Last updated
Start date December 9, 2021
Est. completion date July 26, 2023

Study information
Verified date September 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date July 26, 2023
Est. primary completion date July 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Relatlimab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations
Country Name City State
Belgium Local Institution - 0017 Antwerpen
Belgium Local Institution - 0016 Brussels
Belgium Local Institution - 0018 Bruxelles Brussels
Belgium Local Institution - 0038 Bruxelles
Canada Local Institution - 0044 Ottawa Ontario
Germany Local Institution - 0037 Erlangen
Germany Local Institution - 0034 Essen
Germany Local Institution - 0036 Gera
Germany Local Institution - 0035 Hannover
Germany Local Institution - 0033 Heidelberg
Germany Local Institution - 0032 Lübeck
Germany Local Institution - 0040 Nuremberg
Spain Local Institution - 0026 Barcelona
Spain Local Institution - 0030 Cordoba
Spain Local Institution - 0027 Hospitalet de Llobregat - Barcelona
Spain Local Institution - 0029 Madrid
Spain Local Institution - 0031 San Sebastian
Spain Local Institution - 0028 Valencia
United States Local Institution - 0003 Ann Arbor Michigan
United States Local Institution - 0004 Chicago Illinois
United States Local Institution - 0002 Los Angeles California
United States Local Institution - 0005 Los Angeles California
United States Local Institution - 0015 Miami Florida
United States Local Institution - 0008 Morristown New Jersey
United States Local Institution - 0001 Santa Monica California
United States Local Institution - 0023 Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Spain, 

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