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Phase II clinical trial of cemiplimab, an anti-PD-1 monoclonal antibody, and ISA101b vaccine in patients with recurrent/metastatic HPV16-positive oropharyngeal cancer (OPC) who have experienced disease progression.
THE PRIMARY OBJECTIVE OF THIS STUDY IS TO 1) EVALUATE THE SAFETY AND TOLERABILITY OF THE COMBINATION OF CEMIPLIMAB AND ISA101B FOR THE TREATMENT OF COF, AND 2) DETERMINE WHETHER THE ADDITION OF ISA101B TO CEMIPLIMAB IMPROVES THE CANCER RESPONSE RATE AND SURVIVAL RATE.
Technical Summary
- PHASE II STUDY OF CEMIPLIMAB, AN ANTI-PD-1 MONOCLONAL ANTIBODY, AND ISA101B VACCINE, IN PATIENTS WITH RECURRENT/METASTATIC HPV16-POSITIVE OROPHARYNGEAL CANCER (COF) WHO HAVE EXPERIENCED DISEASE PROGRESSION WITH PRIOR ANTI-PD-1 TREATMENT. IMMUNOTHERAPY
- Code EudraCT: 2020-003652-32
- Protocol number: ISA101b-OPC-03-19
- Promoter: Isa Therapeutics
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