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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
Results First Posted : March 29, 2022
Last Update Posted : October 6, 2022
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
Results First Submitted Date  ICMJE January 25, 2022
Results First Posted Date  ICMJE March 29, 2022
Last Update Posted Date October 6, 2022
Actual Study Start Date  ICMJE April 11, 2018
Actual Primary Completion Date January 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2022)
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.
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
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2022)
  • 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").
  • 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).
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
 (submitted: March 2, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
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 relatlimab in combination with nivolumab 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 * Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 8, 2021)
714
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
700
Estimated Study Completion Date  ICMJE December 16, 2025
Actual Primary Completion Date January 25, 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 information is only displayed when the study is recruiting subjects
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
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2022

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