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A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470922
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE April 10, 2018
Estimated Primary Completion Date January 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)
  • PFS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial, assessed by a BICR
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)
  • Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial, assessed by a BICR
Change History Complete list of historical versions of study NCT03470922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial
  • ORR [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial, assessed by a BICR
  • ORR [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups
  • PFS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In subgroups.
  • OS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups
  • Number of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of AEs Leading to Discontinuation [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of Deaths [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of Laboratory Abnormalities [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial. To compare BMS-986213 to nivolumab monotherapy
  • ORR [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial, assessed by a BICR
  • ORR [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial, assessed by a BICR in subgroups
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups
  • Disease Control Rate (DCR) [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups
  • PFS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups
  • OS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups
  • Nubmer of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of AEs Leading to Discontinuation [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of Deaths [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
  • Number of Laboratory Abnormalities [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Official Title  ICMJE A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Brief Summary The purpose of this study is to determine whether nivolumab in combination with relatlimab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • Biological: Relatlimab
    Specified dose on specified day
  • Biological: Nivolumab
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Arm A: Relatlimab + Nivolumab
    Combination
    Interventions:
    • Biological: Relatlimab
    • Biological: Nivolumab
  • Experimental: Arm B: Nivolumab
    Monotherapy
    Intervention: Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 16, 2022
Estimated Primary Completion Date January 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
  • Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

Exclusion Criteria:

  • Participants must not have active brain metastases or leptomeningeal metastases
  • Participants must not have uveal melanoma
  • Participants must not have an active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   New Zealand,   Norway,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03470922
Other Study ID Numbers  ICMJE CA224-047
2017-003583-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP