Spots Global Cancer Trial Database for Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix

Official Title: Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix

Study ID: NCT05063916

Conditions

Carcinomas

Cervix Cancer

Cervical Cancer

Interventions

AK104

Study Description

Brief Summary: 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.

Detailed Description: 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