A Phase II And Phase III Peri-Operative Trial Of Fianlimab And Cemiplimab Compared With Anit-PD1 Alone In Patients With Resectable Stage III and IV Melanoma

Phase II objective is to compare the treatment effect of the combination of fianlimab and cemiplimab to cemiplimab alone as peri-operative therapy in patients with resectable melanoma.
Phase III objective is to assess the EFS for the combination of fianlimab and cemiplimab vs pembrolizumab alone as peri-operative therapy in patients with resectable melanoma. 

For more information, visit: https://clinicaltrials.gov/study/NCT06190951

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

•  At least 18 years of age on the date of providing informed consent
• Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative  margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization.
• All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization.  Imaging must include a CT scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain MRI (or brain CT with contrast allowed if MRI is contraindicated).

•  Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
• Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion.
• Primary uveal melanoma