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Completed

NCT Number: NCT03068455

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

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, North Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified Dose on Specified Days

Other names: Opdivo, BMS-936558

Ipilimumab

Biological

Specified Dose on Specified Days

Other names: Yervoy, BMS-734016

Primary outcomes

  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.

  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.

Secondary outcomes

  1. Overall Survival (OS) - All Randomized Participants

    Time frame: 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.

  2. Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%

    Time frame: 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.

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

    Time frame: 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.

  4. Time to Next-Line Therapies - All Randomized Participants

    Time frame: 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.

  5. Time to 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 (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

  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 (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.

  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 (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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: CheckMate 915

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 1, 2017
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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