The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).
Histologically proven diagnosis of Merkel cell carcinoma (MCC).
Clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence. This includes patients with a previous diagnosis of clinical Stage I-II who present with local or regional disease recurrence.
Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy. If sentinel biopsy is determined to not be clinically indicated then it would not be required to be completed and only the tumor excision would be required.
Patients with stage III to stage IV (M0) CSCC of the head/neck, extremity, or trunk, and selected patients with stage II CSCC (≥3 cm longest diameter lesion in an aesthetically-sensitive region), for whom surgery is planned.
Concurrent malignancy other than localized CSCC and/or history of malignancy other than Merkel cell carcinoma within 3 years of date of registration on the study, except for tumors with negligible risk of metastasis or death, such as adequately treated (BCC) of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low- risk early stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score ≤6 and prostate-specific antigen (PSA) ≤10 ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of >12 months for which the management plan is active surveillance.
Patients with hematologic malignancies (eg, chronic lymphocytic leukemia [CLL]).
Ongoing or recent (within 5 years of registration date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). Further, patients requiring chronic immune-suppressive therapy are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
Pregnancy or lactation.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Sanofi-Synthelabo
Collaborator