NL-OMON50102
Not yet recruiting
Phase 2
Prospective randomized trial of an adjuvant therapy of completely resected Merkel Cell Carcinoma (MCC) with immune checkpoint blocking antibodies (Nivolumab, Opdivo®; Ipilimumab, Yervoy®) versus observation - ADMEC-O
niversity Hospital Essen0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital Essen
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The patient is willing and able to give written informed consent.
- •2\. Central histological confirmation of diagnosis of Merkel cell carcinoma
- •3\. All MCC manifestations have been completely resected by surgery within 12
- •weeks before enrolment.
- •4\. No currently present metastases (as confirmed by standard imaging studies
- •(e.g. suggested by S2k guidelines).
- •5\. No previous systemic therapy for MCC.
- •6\. Required values for initial laboratory tests: \*
- •WBC \>\= 2000/uL \*
- •ANC \>\= 1000/uL \*
Exclusion Criteria
- •1\. Autoimmune disease: Patients with a history of inflammatory bowel disease,
- •including ulcerative colitis and Crohn\*s Disease, are excluded from this study,
- •as are patients with a history of symptomatic disease requiring systemic
- •steroids (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic
- •lupus erythematosus, autoimmune vasculitis); autoimmune motor neuropathy.
- •2\. Other serious illnesses, e.g., serious infections requiring i.v.
- •antibiotics.
- •3\. The patient is known to be positive for Human Immunodeficiency Virus (HIV)
- •or other chronic infections (HBV, HCV) or has another confirmed or suspected
- •immunosuppressive or immune deficient condition.
Outcomes
Primary Outcomes
Not specified
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