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

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ClinicalTrials.gov Identifier: NCT03470922

Recruitment Status : Recruiting

First Posted : March 20, 2018

Last Update Posted : September 1, 2020

See Contacts and Locations

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

September 1, 2020

Actual Study Start Date ^ICMJE

April 10, 2018

Estimated Primary Completion Date

May 24, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

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

700

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

March 16, 2023

Estimated Primary Completion Date

May 24, 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

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

PRS Account

Bristol-Myers Squibb

Verification Date

August 2020

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

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