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A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment

  • Clinicaltrials.gov identifier

    NCT03978611

  • Recruitment Status

    Recruiting

  • First Posted

    June 7, 2019

  • Last update posted

    August 25, 2021

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

Study Description

Brief summary:

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

  • Condition or Disease:Melanoma
  • Intervention/Treatment: Drug: Relatlimab
    Drug: Ipilimumab
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 260 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: April 2023
  • Estimated Study Completion Date: July 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation Phase
 Drug: Relatlimab
Participants will receive IV infusion of relatlimab in Part 1 and Part 2

Drug: Ipilimumab
Participants will receive IV infusion of ipilimumab in Part 1 and Part 2.
Experimental: Part 2: Dose Expansion Phase
 Drug: Relatlimab
Participants will receive IV infusion of relatlimab in Part 1 and Part 2

Drug: Ipilimumab
Participants will receive IV infusion of ipilimumab in Part 1 and Part 2.

Outcome Measures

  • Primary Outcome Measures: 1. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
  • 2. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
  • 3. Number of Participants With Adverse Events Including Dose Limiting Toxicity [ Time Frame: Up to 28 days after last study drug dose (approximately up to 2 years) ]
  • 4. Number of Participants with AEs resulting in Discontinuation [ Time Frame: Up to end of study (approximately 2.4 years) ]
  • 5. Number of Participants with AEs resulting in Death [ Time Frame: Up to end of study (approximately 2.4 years) ]
  • 6. Number of Participants with AEs resulting in Laboratory Abnormalities [ Time Frame: Up to end of study (approximately 2.4 years) ]
  • 7. Objective Response Rate (ORR) [ Time Frame: Approximately 2.4 years ]
  • Secondary Outcome Measures: 1. Duration of response (DOR) [ Time Frame: Approximately Up to 2.4 years ]
  • 2. Median PFS [ Time Frame: 6 and 12 months ]
  • 3. Median Overall Survival (OS) [ Time Frame: 1 and 2 years ]
  • 4. Number of Participants with Anti-Drug Antibodies (ADA)-Positivity [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
  • 5. Progression Free Survival rates (PFS rates) [ Time Frame: at 24 weeks and at 1 year ]
    Progression free survival rates (PFS rates)
  • 6. Overall Survival Rates (OS rates) [ Time Frame: at 1 year and at 2 years ]
    Overall Survival Rates (OS rates)
  • 7. Objective Response Rate (ORR) [ Time Frame: up to 2.4 years ]
    Objective Response Rate (ORR)

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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. - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test - Participants 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. - BRAF wild type and mutant participants are eligible - Eastern Cooperative Oncology Group (ECOG) 0-1 - Ability to comply with treatment, patient-reported outcomes (PROs), PK, and pharmacodynamic sample collection and required study follow-up 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 CTLA-4 or LAG-3 targeted agents - Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibody.

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arizona
Local Institution
Tucson

United States, California
Hoag Memorial Hospital Presbyterian
Los Angeles

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles

United States, California
John Wayne Cancer Institute
Santa Monica

United States, Colorado
Local Institution
Aurora

United States, Florida
Sylvester Comprehensive Cancer Center
Miami

United States, Florida
Local Institution
Tampa

United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago

United States, Michigan
University of Michigan
Ann Arbor

United States, New Jersey
Atlantic Health System
Morristown

United States, Texas
Local Institution
San Antonio

United States, Texas
Local Institution
San Antonio

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Local Institution
Charlottesville

Belgium
Local Institution
Antwerpen

Belgium
Local Institution
Brussels

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Bruxelles

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Toronto

Canada
Local Institution
Quebec

France
Local Institution
Bordeaux

France
Local Institution
Lyon

France
Local Institution
Marseille Cedex 5

France
Local Institution
Nantes Cedex 1

France
Local Institution
Paris

Germany
Local Institution
Erlangen

Germany
Local Institution
Essen

Germany
Local Institution
Gera

Germany
Local Institution
Hannover

Germany
Local Institution
Hannover

Germany
Local Institution
Heidelberg

Germany
Local Institution
Lübeck

Germany
Local Institution
Nurnberg

Spain
Local Institution
Barcelona

Spain
Local Institution
Cordoba

Spain
Local Institution
Hospitalet de Llobregat - Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
San Sebastian

Spain
Local Institution
Valencia

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03978611 History of Changes
  • Other Study ID Numbers: CA224-083, 2019-000132-25
  • First Posted: June 7, 2019 Key Record Dates
  • Last Update Posted: August 25, 2021
  • Last Verified: August 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Melanoma