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.

Inclusion Criteria: 1. Ability to provide written and signed informed consent. 2. Age ≥ 18 years at time of study entry 3. Histologically or cytologically confirmed recurrent or metastatic high grade neuroendocrine carcinoma of the cervix with disease progression confirmed by radiologic imaging during or following prior platinum-based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer 4. Received no more than 2 prior systemic therapies in the recurrent or metastatic setting 5. Not eligible for surgery and/or radiation as treatment options for recurrent disease 6. Measurable lesions according to RECIST v1.1. (A previously irradiated lesion is not considered measurable and cannot be selected as a target lesion.) 7. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 8. Adequate organ function as determined by: 1. Hematological criteria (subjects should not have received either growth factor support or recent transfusions within 7 days prior to starting study treatment): * Absolute neutrophil count (ANC) ≥1.5 × 109/L (1,500/mm3) * Platelet count ≥100 × 109/L (100,000/mm3) * Hemoglobin ≥9.0 g/dL (90 g/L) 2. Renal criteria: \- Serum creatinine \