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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 : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Condition or disease Intervention/treatment Phase
Melanoma Biological: Relatlimab Biological: Nivolumab Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : January 27, 2021
Estimated Study Completion Date : March 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Relatlimab + Nivolumab
Combination
 Biological: Relatlimab
Specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Arm B: Nivolumab
Monotherapy
 Biological: Nivolumab
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)

  2. PFS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial, assessed by a BICR


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial

  2. ORR [ Time Frame: Up to 5 years ]
    Phase 3 portion of trial, assessed by a BICR

  3. ORR [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups

  4. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups

  5. PFS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In subgroups.

  6. OS [ Time Frame: Up to 5 years ]
    Phase 2 portion of trial. In the randomized population and in subgroups

  7. Number of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial

  8. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial

  9. Number of AEs Leading to Discontinuation [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial

  10. Number of Deaths [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial

  11. Number of Laboratory Abnormalities [ Time Frame: Up to 5 years ]
    Phase 2 portion of the trial


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470922


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03470922    
Other Study ID Numbers: CA224-047
2017-003583-12 ( EudraCT Number )
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Cancer
Advanced Cancer
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents