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

  • Clinicaltrials.gov identifier

    NCT03978611

  • Recruitment Status

    Recruiting

  • First Posted

    June 7, 2019

  • Last update posted

    April 4, 2022

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). It is also 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/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 215 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: August 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation Phase
Drug: Relatlimab
Specified dose on specified days

Drug: Ipilimumab
Specified dose on specified days
Experimental: Part 2: Dose Expansion Phase
Drug: Relatlimab
Specified dose on specified days

Drug: Ipilimumab
Specified dose on specified days

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) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to approximately 2.4 years ]
  • Secondary Outcome Measures: 1. Duration of response (DOR) assessed by BICR using RECIST 1.1 [ Time Frame: Up to approximately 2.4 years ]
  • 2. ORR assessed by investigator using RECIST 1.1 [ Time Frame: Up to approximately 2.4 years ]
  • 3. DOR assessed by investigator using RECIST 1.1 [ Time Frame: Up to approximately 2.4 years ]
  • 4. Investigator-assessed median progression free survival (PFS) [ Time Frame: Up to approximately 1 year ]
  • 5. Investigator-assessed PFS rates [ Time Frame: Up to approximately 1 year ]
  • 6. BICR-assessed median PFS [ Time Frame: Up to approximately 1 year ]
  • 7. BICR-assessed PFS rates [ Time Frame: Up to approximately 1 year ]
  • 8. Median Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
  • 9. Overall Survival Rates (OS rates) [ Time Frame: Up to approximately 2 years ]
  • 10. 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]) ]

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 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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

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

Locations

United States, Arizona
Arizona Cancer Center
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, Quebec
Local Institution
Sherbrooke

Canada
Local Institution
Quebec

France
Local Institution
Bordeaux

France
Local Institution
Lyon

France
Local Institution
Marseille Cedex 5

France
Local Institution
Nantes

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: April 4, 2022
  • Last Verified: March 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Melanoma
    Neuroendocrine Tumors
    Neuroectodermal Tumors
    Neoplasms, Germ Cell and Embryonal
    Neoplasms by Histologic Type
    Neoplasms
    Neoplasms, Nerve Tissue
    Nevi and Melanomas