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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03978611
Collaborator
(none)
215
Enrollment
40
Locations
2
Arms
58.7
Anticipated Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
215 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 :
Oct 7, 2019
Anticipated Primary Completion Date :
Jun 27, 2023
Anticipated Study Completion Date :
Aug 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Dose Escalation Phase

Drug: Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986016

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

    Drug: Relatlimab
    Specified dose on specified days
    Other Names:
  • BMS-986016

    • Drug: Ipilimumab
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [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) [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 [Up to 28 days after last study drug dose (approximately up to 2 years)]

    4. Number of Participants with AEs resulting in Discontinuation [Up to end of study (approximately 2.4 years)]

    5. Number of Participants with AEs resulting in Death [Up to end of study (approximately 2.4 years)]

    6. Number of Participants with AEs resulting in Laboratory Abnormalities [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 [Up to approximately 2.4 years]

    Secondary Outcome Measures

    1. Duration of response (DOR) assessed by BICR using RECIST 1.1 [Up to approximately 2.4 years]

    2. ORR assessed by investigator using RECIST 1.1 [Up to approximately 2.4 years]

    3. DOR assessed by investigator using RECIST 1.1 [Up to approximately 2.4 years]

    4. Investigator-assessed median progression free survival (PFS) [Up to approximately 1 year]

    5. Investigator-assessed PFS rates [Up to approximately 1 year]

    6. BICR-assessed median PFS [Up to approximately 1 year]

    7. BICR-assessed PFS rates [Up to approximately 1 year]

    8. Median Overall Survival (OS) [Up to approximately 2 years]

    9. Overall Survival Rates (OS rates) [Up to approximately 2 years]

    10. Number of Participants with Anti-Drug Antibodies (ADA)-Positivity [Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724
    2 Hoag Memorial Hospital Presbyterian Los Angeles California United States 90033
    3 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033
    4 John Wayne Cancer Institute Santa Monica California United States 90404
    5 Local Institution Aurora Colorado United States 80045
    6 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    7 Local Institution Tampa Florida United States 33612
    8 Northwestern University, Feinberg School of Medicine Chicago Illinois United States 60611
    9 University of Michigan Ann Arbor Michigan United States 48109
    10 Atlantic Health System Morristown New Jersey United States 07960
    11 Local Institution San Antonio Texas United States 78229
    12 Local Institution Salt Lake City Utah United States 84112
    13 Local Institution Charlottesville Virginia United States 22908
    14 Local Institution Antwerpen Belgium 2020
    15 Local Institution Brussels Belgium 1090
    16 Local Institution Bruxelles Belgium 1000
    17 Local Institution Bruxelles Belgium 1200
    18 Local Institution - 0044 Ottawa Ontario Canada K1H 8L6
    19 Local Institution Toronto Ontario Canada M5G 2M9
    20 Local Institution Sherbrooke Quebec Canada J1H 5N4
    21 Local Institution Quebec Canada G1R 2J6
    22 Local Institution Bordeaux France 33000
    23 Local Institution Lyon France 69008
    24 Local Institution Marseille Cedex 5 France 13385
    25 Local Institution Nantes France 44093
    26 Local Institution Paris France 75475
    27 Local Institution Erlangen Germany 91054
    28 Local Institution Essen Germany 45147
    29 Local Institution Gera Germany 07548
    30 Local Institution Hannover Germany 30625
    31 Local Institution Hannover Germany 30625
    32 Local Institution Heidelberg Germany 69120
    33 Local Institution Lübeck Germany 23562
    34 Local Institution Nurnberg Germany 90419
    35 Local Institution Barcelona Spain 08035
    36 Local Institution Cordoba Spain 14004
    37 Local Institution Hospitalet de Llobregat - Barcelona Spain 08908
    38 Local Institution Madrid Spain 28034
    39 Local Institution San Sebastian Spain 20014
    40 Local Institution Valencia Spain 46009

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03978611
    Other Study ID Numbers:
    • CA224-083
    • 2019-000132-25
    First Posted:
    Jun 7, 2019
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma
    Ipilimumab

    Study Results

    No Results Posted as of May 18, 2022