A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 1844
- Locations
- 70
- Primary Endpoint
- Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
- •Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
- •No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
Exclusion Criteria
- •History of uveal melanoma
- •Patients with active, known or suspected autoimmune disease
- •Prior treatment with interferon (if complete \< 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Other protocol defined inclusion/exclusion criteria could apply
Outcomes
Primary Outcomes
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
Time Frame: From randomization to Primary Completion Date (up to approximately 3 years)
RFS was 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 (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates.
Recurrence-free Survival (RFS) - All Randomized Participants
Time Frame: From randomization to Primary Completion Date (up to approximately 3 years)
RFS was 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 (from any cause), whichever occurred first. Median values based on Kaplan-Meier Estimates.
Secondary Outcomes
- Overall Survival (OS) - All Randomized Participants(From randomization to date of death (up to approximately 45 months))
- Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%(From randomization to date of death (up to approximately 45 months))
- Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%(From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months))
- Time to Next-Line Therapies - All Randomized Participants(From randomization to start of next therapy or second next therapy (up to approximately 45 months))
- Time From Next Therapy to Second Next Therapy - All Randomized Participants(From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months))
- Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%(From randomization to start of next therapy or second next therapy (up to approximately 45 months))
- Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants(From randomization to progression event (up to approximately 45 months))
- Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression(From randomization to Study Completion Date (up to approximately 45 months))
- Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%(From randomization to progression event (up to approximately 45 months))