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An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab or Ipilimumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma (CheckMate 915)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03068455
First received: February 27, 2017
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab or Ipilimumab 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 Intervention Phase
Melanoma Biological: nivolumab Biological: ipilimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Ipilimumab or Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Recurrence-free survival (RFS) [ Time Frame: Approximately 3 years ]
    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


Estimated Enrollment: 1125
Actual Study Start Date: April 7, 2017
Estimated Study Completion Date: January 20, 2023
Estimated Primary Completion Date: December 9, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: ipilimumab
Specified Dose on Specified Days
Biological: ipilimumab
Specified Dose on Specified Days
Other Names:
  • Yervoy
  • BMS-734016

  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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
  • Weight less than or equal to 40 kg
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03068455

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 82 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03068455     History of Changes
Other Study ID Numbers: CA209-915
2016-003729-41 ( EudraCT Number )
Study First Received: February 27, 2017
Last Updated: April 19, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017