An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

Phase 3

Completed

Conditions: Melanoma

Registration Number: NCT03068455

Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1844

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%	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	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 Outcome Measures

Name	Time	Method
Overall Survival (OS) - All Randomized Participants	From randomization to date of death (up to approximately 45 months)	OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%	From randomization to date of death (up to approximately 45 months)	OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
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 from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
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 to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date. Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date.
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 from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
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)	Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date. Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants	From randomization to progression event (up to approximately 45 months)	PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression	From randomization to Study Completion Date (up to approximately 45 months)	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.
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)	PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.

Trial Locations

Locations (70): University of Arizona Cancer Center
🇺🇸
Tucson, Arizona, United States
The Angeles Clinic & Research Institute
🇺🇸
Los Angeles, California, United States
California Pacific Medical Center
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San Francisco, California, United States
University Of Colorado
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Aurora, Colorado, United States
Georgetown University Med Ctr
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Washington, District of Columbia, United States
Mount Sinai Comprehensive Cancer Center
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Miami Beach, Florida, United States
UF Health Cancer Center at Orlando Health
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Orlando, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Winship Cancer Institute
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Atlanta, Georgia, United States
University Of Chicago
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Chicago, Illinois, United States
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University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States