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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

NCT03068455

Description:

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

Related Conditions:
  • Melanoma
Recruiting Status:

Completed

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03068455

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-915
  • SECONDARY ID: 2016-003729-41
  • NCT ID: NCT03068455

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
nivolumabOpdivo, BMS-936558nivolumab
ipilimumabYervoy, BMS-734016nivolumab + ipilimumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
nivolumab + ipilimumabExperimentalSpecified Dose on Specified Days
  • nivolumab
  • ipilimumab
nivolumabExperimentalSpecified Dose on Specified Days
  • nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence-free Survival (RFS) - All Randomized Participants
Time Frame:From randomization to Primary Completion Date (up to approximately 3 years)
Safety Issue:
Description: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. Statistical analysis was performed upon reaching the number of recurrence events specified in the protocol to obtain a statistically significant difference in RFS between the treatment arms with approximately 90% power when the average hazard ratio (HR) of the nivolumab plus ipilimumab arm to the nivolumab arm is 0.76.

Secondary Outcome Measures

Measure:Overall Survival (OS) - All Randomized Participants
Time Frame:From randomization to date of death
Safety Issue:
Description:OS is defined as the time between the date of randomization and the date of death.
Measure:Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
Time Frame:From randomization to date of death
Safety Issue:
Description:OS is defined as the time between the date of randomization and the date of death.
Measure:Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
Time Frame:From randomization to Primary Completion Date (up to approximately 3 years)
Safety Issue:
Description: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.
Measure:Time to Next Therapies - All Randomized Participants
Time Frame:From randomization to start of next therapy or second next therapy
Safety Issue:
Description: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.
Measure:Duration of Treatment on Next-line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
Time Frame:From randomization to start of next therapy or second next therapy
Safety Issue:
Description: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
Measure:Time From Next Therapy to Second Next Therapy - All Randomized Participants
Time Frame:From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Safety Issue:
Description: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.
Measure:Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Time Frame:From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Safety Issue:
Description: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.
Measure:Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
Time Frame:From randomization to progression event
Safety Issue:
Description: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.
Measure:Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Time Frame:From randomization to progression event
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Bristol-Myers Squibb

Last Updated

July 22, 2021