The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,093
Specified dose on specified days
Specified dose on specified days
Recurrence Free Survival (RFS)
RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
Time frame: Approximately 27.5 Months
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause.
Time frame: Approximately 27.5 Months
Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first.
Time frame: Approximately 27.5 Months
Progression Free Survival on Next-Line Systemic Therapy (PFS2)
PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first.
Time frame: Approximately 27.5 Months
Number of Participants With Safety Related Events
Safety related events encompass the following measures: Adverse events (AEs), Serious AEs, AEs leading to discontinuation, Drug-Related AEs and Deaths. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An SAE is an AE which: * Results in death * Is life threatening * Requires hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event
Time frame: Approximately 27.5 Months
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Local Institution - 0176
Birmingham, Alabama, United States
Local Institution - 0164
Springdale, Arkansas, United States
Local Institution - 0200
Los Angeles, California, United States
Local Institution - 0185
Palo Alto, California, United States
Local Institution - 0162
San Francisco, California, United States
Saint John's Cancer Institute
Santa Monica, California, United States
Local Institution - 0138
Aurora, Colorado, United States
Local Institution - 0166
Washington D.C., District of Columbia, United States
Local Institution - 0243
Miami, Florida, United States
Washington University School Of Medicine
Miami, Florida, United States
...and 174 more locations
Number of Participants With Select AEs
Select AEs will be reported as AEs per organ class. Organ classes which will be reported: * Gastrointestinal * Hepatic * Pulmonary * Renal * Skin * Hypersensitivity/Infusion reaction
Time frame: Approximately 27.5 Months
Number of Participants With Endocrine Related Immune Mediated AEs
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Time frame: Approximately 27.5 Months
Number of Participants With Non-endocrine Related Immune Mediated AEs
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Time frame: Approximately 27.5 Months
Laboratory Abnormalities for Specific Thyroid Tests
Number of participants with laboratory abnormalities in specific thyroid tests.
Time frame: Approximately 27.5 Months