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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 (CheckMate 915)

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ClinicalTrials.gov Identifier: NCT03068455
Recruitment Status : Completed
First Posted : March 1, 2017
Results First Posted : July 22, 2021
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Melanoma Biological: nivolumab Biological: ipilimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1844 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: nivolumab + ipilimumab
Specified Dose on Specified Days
Biological: nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Biological: ipilimumab
Specified Dose on Specified Days
Other Names:
  • Yervoy
  • BMS-734016

Experimental: nivolumab
Specified Dose on Specified Days
Biological: nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558




Primary Outcome Measures :
  1. 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. 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.


  2. 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. 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 :
  1. Overall Survival (OS) - All Randomized Participants [ Time Frame: From randomization to date of death ]
    OS is defined as the time between the date of randomization and the date of death.

  2. Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1% [ Time Frame: From randomization to date of death ]
    OS is defined as the time between the date of randomization and the date of death.

  3. Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression [ 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.


  4. Time to Next Therapies - All Randomized Participants [ Time Frame: From randomization to start of next therapy or second next therapy ]

    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.


  5. 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 ]

    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


  6. 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) ]
    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.

  7. 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) ]
    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.

  8. Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants [ Time Frame: From randomization to progression event ]
    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.

  9. Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1% [ Time Frame: From randomization to progression event ]
    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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068455


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] March 11, 2019
Statistical Analysis Plan  [PDF] August 23, 2019

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03068455    
Other Study ID Numbers: CA209-915
2016-003729-41 ( EudraCT Number )
First Posted: March 1, 2017    Key Record Dates
Results First Posted: July 22, 2021
Last Update Posted: July 22, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents