NL-OMON47131
Completed
Phase 3
Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group - EORTC protocol 18071
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ELIGIBILITY CRITERIA
- •To be eligbile to participate in this study, patients must be/ have
- •\* At least 18 years of age
- •\* No mucosal or ocular (eye) melanoma, or melanoma with unknown origin of the
- •\* Complete surgical removal (resection) of Stage III melanoma with cutaneous melanoma spread to lymph node,confirmed by microscopy and classified by the American Joint Committee on Cancer (AJCC, 2002\) as: Stage IIIA with metastasis greater than 1mm thick; any Stage IIIB or IIIC (no in\*transit spread)
- •\* Adequate removal of Stage III lymph nodes per Criteria for adequate surgical procedures for complete lymph node dissection (CLND) as documented on the operating report and pathology report. (Patients without documentation of
- •adequate resection are not eligible).
- •\* General recommendations for surgical and pathological procedures are given in Appendix J of the protocol; a data quality check will be done based on the surgical and pathological reports
- •\* Recommendations for management of the lymph nodes are given in Appendix
- •J of the protocol and should include the following:
Exclusion Criteria
- •This is mentioned in the Eligibility criteria
Outcomes
Primary Outcomes
Not specified
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