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A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma (RELATIVITY-047)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470922
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether relatlimab in combination with nivolumab 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 714 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 11, 2018
Actual Primary Completion Date : January 25, 2021
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

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




Primary Outcome Measures :
  1. Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 32 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 years ]
  2. Overall response rate (ORR) as assessed by BICR [ Time Frame: Up to 5 years ]

Other Outcome Measures:
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  3. Incidence of AEs Leading to Discontinuation [ Time Frame: Up to 5 years ]
  4. Incidence of Deaths [ Time Frame: Up to 5 years ]
  5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 5 years ]
  6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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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


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


Locations
Show Show 127 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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: July 14, 2021
Last Verified: July 2021

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action