EUCTR2016-003729-41-IT
Active, not recruiting
Phase 1
A Phase 3, Randomized Study of Adjuvant Immunotherapy with NivolumabCombined with Ipilimumab Versus Nivolumab Monotherapy after CompleteResection of Stage IIIb/c/d or Stage IV Melanoma. - CheckMate 915
ConditionsStage 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanomafollowing complete resection of the lesion(s) with high risk of relapse.
- Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Enrollment
- 1844
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
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:
- •F.1\.2 Adults (18\-64 years) yes
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
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