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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03068455
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1943 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 7, 2017
Estimated Primary Completion Date : June 11, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-free survival (RFS) [ Time Frame: Approximately 30 months ]
    measured by time


Secondary Outcome Measures :
  1. Overall Survival (OS); Objective response rates (if applicable); Duration of treatment on next-line therapies: PFS2, End-of-next-line-treatment [ Time Frame: Up to 5 years ]
    OS: measured by time; Second recurrence/objective disease progression (PFS2)

  2. PD-L1 expression [ Time Frame: Approximately 3 years ]
    measured by immunoassay


Eligibility Criteria
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Information from the National Library of Medicine

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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

Contacts and Locations
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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
More Information
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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
Last Update Posted: May 13, 2020
Last Verified: May 2020

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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