A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma (RELATIVITY-047)
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : March 20, 2018
Results First Posted : March 29, 2022
Last Update Posted : March 29, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma | Biological: Relatlimab Biological: Nivolumab | Phase 2 Phase 3 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Relatlimab + Nivolumab
Combination
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Biological: Relatlimab
Specified dose on specified day Biological: Nivolumab Specified dose on specified days |
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Experimental: Arm B: Nivolumab
Monotherapy
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Biological: Nivolumab
Specified dose on specified days |
- 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.
- 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).
- 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.
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.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cancer Advanced Cancer |
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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 |