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Clinical Trials/EUCTR2016-003729-41-BE
EUCTR2016-003729-41-BE
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 14, 2017
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ConditionsStage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse.MedDRA version: 20.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo(TM)Yervoy (TM)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse.
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
2560
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 14, 2017
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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: 13
  • •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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Phase 1
A Study of Nivolumab in Combination with Ipilimumab Compared toNivolumab Alone in Treatment of Patients After Complete Resection ofStage IIIb/c/d or Stage IV Melanoma.Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanomafollowing complete resection of the lesion(s) with high risk of relapse.MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab or Ipilimumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse.MedDRA version: 19.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.
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A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.
EUCTR2016-003729-41-Outside-EU/EEABristol-Myers Squibb International Corporation1,844
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A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.
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