NCT04099251Active, not recruitingPhase 3
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Bristol-Myers Squibb239 sites in 7 countries790 target enrollmentStarted: October 28, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 790
- Locations
- 239
- Primary Endpoint
- Recurrence Free Survival (RFS)
Study Overview
Brief Summary
The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Had a negative sentinel lymph node biopsy.
- •Participant has not been previously treated for melanoma.
- •ECOG 0 or
- •Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma.
Exclusion Criteria
- •History of ocular or mucosal melanoma.
- •Pregnant or nursing women.
- •Participants with active known or suspected autoimmune disease.
- •Known history of allergy or hypersensitivity to study drug components.
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways.
- •Other protocol defined inclusion/exclusion criteria apply.
Arms & Interventions
Nivolumab
Experimental
Intervention: Nivolumab (Biological)
Placebo
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Recurrence Free Survival (RFS)
Time Frame: From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.
Secondary Outcomes
- Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Progression-Free Survival Through Next-Line Therapy(From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months))
- Number of Participants Experiencing Death(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Distant Metastasis-Free Survival (DMFS)(From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months))
- Duration of Treatment on Next Line Therapy Per Investigator Assessment(From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months))
- Number of Participants Experiencing Adverse Events Leading to Discontinuation(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Number of Participants Experiencing Select Adverse Events(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Number of Participants Experiencing Adverse Events (AEs)(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Number of Participants Experiencing Serious Adverse Events (SAEs)(From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
- Overall Survival (OS)(From randomization up to the date of death or the last date the participant was known to be alive)
Investigators
Study Sites (239)
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