I-MAT MASC 03.18
Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma
Trial summary:
Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma
Receptor status / problem studied:
Stage I-III Merkel Cell Carcinoma
Inclusion criteria
- Histologically confirmed Merkel cell carcinoma (MCC) which is either:
- clinical stage I (pathological stage I MCC patients are not eligible for the study);
- clinical or pathological stage II (including IIA and IIB);
- clinical or pathological stage III (including IIIA and IIIB).
- Absence of distant metastatic disease on baseline 18-Fludeoxyglucose (18FDG) – Positron Emission Tomography (PET) / Computed Tomography (CT) scan.
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) of 0 – 2.
Exclusion criteria
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest significant risk for immune-related adverse events.
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Previous cancer immunotherapy, specifically interferon, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways are not permitted.
- Prior treatment with other immune-modulating agents that was within fewer than 28 days prior to the first dose of Avelumab.
Open for recruitment
Trial Title
I-MAT / MASC 03.18
Diagnosis
Skin cancer – non-melanoma
Type of trial
Collaborative
Type of treatement
Medical Oncology
Phase
II
Locations
Investigators
Principal Investigator