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

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

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: Ipilimumab; Drug: Relatlimab

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • Local Institution - 0017
  • Brussels, Belgium, 1090
    • Local Institution - 0016
  • Bruxelles, Belgium, 1200
    • Local Institution - 0038
  • Brussels
    • Bruxelles, Brussels, Belgium, 1000
      • Local Institution - 0018
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution - 0044
• Germany
  • Erlangen, Germany, 91054
    • Local Institution - 0037
  • Essen, Germany, 45147
    • Local Institution - 0034
  • Gera, Germany, 07548
    • Local Institution - 0036
  • Hannover, Germany, 30625
    • Local Institution - 0035
  • Heidelberg, Germany, 69120
    • Local Institution - 0033
  • Lübeck, Germany, 23562
    • Local Institution - 0032
  • Nuremberg, Germany, 90419
    • Local Institution - 0040
• Spain
  • Barcelona, Spain, 08035
    • Local Institution - 0026
  • Cordoba, Spain, 14004
    • Local Institution - 0030
  • Hospitalet de Llobregat - Barcelona, Spain, 08908
    • Local Institution - 0027
  • Madrid, Spain, 28034
    • Local Institution - 0029
  • San Sebastian, Spain, 20014
    • Local Institution - 0031
  • Valencia, Spain, 46009
    • Local Institution - 0028
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Local Institution - 0023
  • California
    • Los Angeles, California, United States, 90033
      • Local Institution - 0002
    • Los Angeles, California, United States, 90033
      • Local Institution - 0005
    • Santa Monica, California, United States, 90404
      • Local Institution - 0001
  • Florida
    • Miami, Florida, United States, 33136
      • Local Institution - 0015
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Local Institution - 0004
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Local Institution - 0003
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Local Institution - 0008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Escalation Phase	Drug: Ipilimumab; Specified dose on specified days; Drug: Relatlimab; Specified dose on specified days; Other Names: BMS-986016

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab; Relatlimab
• Other Study ID Numbers: CA224-083; 2019-000132-25 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No