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 : Active, not recruiting

First Posted : March 1, 2017

Last Update Posted : October 9, 2018

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

Study Description

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


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2000 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 :	November 8, 2020
Estimated Study Completion Date :	February 17, 2023

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Melanoma

MedlinePlus related topics: Melanoma

Drug Information available for: Ipilimumab Nivolumab

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

Recurrence-free survival (RFS) [ Time Frame: Approximately 30 months ]
measured by time

Secondary Outcome Measures :

Overall Survival (OS) [ Time Frame: Up to 5 years ]
measured by time
PD-L1 expression [ Time Frame: Approximately 3 years ]
measured by immunoassay

Eligibility Criteria

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

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

Show 123 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS Clinical Trial Patient Recruiting This link exits the ClinicalTrials.gov site

Investigator Inquiry Form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site


Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT03068455 History of Changes
Other Study ID Numbers:	CA209-915 2016-003729-41 ( EudraCT Number )
First Posted:	March 1, 2017 Key Record Dates
Last Update Posted:	October 9, 2018
Last Verified:	October 2018


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue	Nevi and Melanomas Nivolumab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs

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