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 |
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Recruitment Status :
Completed
First Posted : March 1, 2017
Results First Posted : July 22, 2021
Last Update Posted : July 22, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma | Biological: nivolumab Biological: ipilimumab | Phase 3 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: nivolumab + ipilimumab
Specified Dose on Specified Days
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Biological: nivolumab
Specified Dose on Specified Days
Other Names:
Biological: ipilimumab Specified Dose on Specified Days
Other Names:
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Experimental: nivolumab
Specified Dose on Specified Days
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Biological: nivolumab
Specified Dose on Specified Days
Other Names:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |