Cervical Cancer Clinical Trial
Official title:
Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix
This is a Phase 2, single center, open-label, single-arm study designed to evaluate the efficacy, safety, tolerability, and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic high grade neuroendocrine cervical cancer.
Primary Objective: -To estimate progression free survival rate at 6 months (PFS6) in response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix. Secondary Objective: - To evaluate the efficacy of AK104 monotherapy in terms of DoR and DCR in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix. - To evaluate the efficacy of AK104 monotherapy in terms of ORR in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix. - To evaluate the safety and tolerability profile of AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix. - To determine presence of HPV cell free DNA and if levels of HPV cell free DNA may serve as a surrogate for response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix ;
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