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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
NameTimeMethod
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 ParticipantsFrom 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
NameTimeMethod
Overall Survival (OS) - All Randomized ParticipantsFrom 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 ParticipantsFrom 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 ParticipantsFrom 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 ParticipantsFrom 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 ExpressionFrom 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

🇺🇸

San Francisco, California, United States

University Of Colorado

🇺🇸

Aurora, Colorado, United States

Georgetown University Med Ctr

🇺🇸

Washington, District of Columbia, United States

Mount Sinai Comprehensive Cancer Center

🇺🇸

Miami Beach, Florida, United States

UF Health Cancer Center at Orlando Health

🇺🇸

Orlando, Florida, United States

H. Lee Moffitt Cancer Center

🇺🇸

Tampa, Florida, United States

Winship Cancer Institute

🇺🇸

Atlanta, Georgia, United States

University Of Chicago

🇺🇸

Chicago, Illinois, United States

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University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States

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