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Clinical Trials/EUCTR2016-003729-41-GB
EUCTR2016-003729-41-GB
Active, not recruiting
Phase 1

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. - CheckMate 915

Bristol-Myers Squibb International Corporation0 sites2,560 target enrollmentMarch 22, 2017
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DrugsOpdivo(TM)Yervoy (TM)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
2560
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 22, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

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).
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 10
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 1884
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 666

Exclusion Criteria

  • •\_History of ocular/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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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