Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Results First Posted : March 29, 2022
Last Update Posted : March 29, 2022
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

Layout table for study information
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) [ Time Frame: From randomization to date of first documented tumor progression or death (up to approximately 33 months) ]
    Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization to the date of death (up to approximately 3 years) ]
    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

  2. Overall Response Rate (ORR) [ Time Frame: From randomization up to approximately 3 years ]
    Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).


Other Outcome Measures:
  1. The Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months) ]

    The number of participants experiencing adverse events (AEs).

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.


  2. The Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months) ]

    The number of participants experiencing serious adverse events (SAEs).

    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.


  3. The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months) ]

    The number of participants experiencing adverse events (AEs) leading to discontinuation.

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.


  4. The Number of Participant Deaths in the Study [ Time Frame: From first dose up to approximately 33 months ]
    The number of participant deaths in the study.

  5. The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months) ]
    The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.

  6. The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months) ]
    The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.



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.


Layout table for eligibility information
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
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] November 23, 2020
Statistical Analysis Plan  [PDF] October 25, 2021

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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
Results First Posted: March 29, 2022
Last Update Posted: March 29, 2022
Last Verified: March 2022

Layout table for additional information
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:
Layout table for MeSH terms
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