Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05824494
Brief Summary:
This is a phase II trial of combination therapy of cadonilimab(Bispecific Anti-PD-1/CTLA-4 Antibody) plus nab-Paclitaxel in patients with recurrent or metastatic cervical cancer that had failed PD-1/PD-L1 blockade therapy. As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by antagonizing CTLA-4, but also block PD-1 and PD-L1/L2 combination. Thereby restoring the killing function of T cells to tumor cells and reducing the exhaustion of T cells.The hypothesis is the combination of cadonilimab and nab-Paclitaxel will overcome PD-1/PD-L1 blockade-resistance to enhance the response of patients with persistant, recurrent or metastatic cervical cancer.
Detailed Description:
Primary objective:
Objective response rate for cadonilimab in combination with nab-paclitaxel in the treatment of persistent, recurrent, or metastatic cervical cancer previously treated with immune checkpoint inhibitors.
Secondary objective:
To evaluate duration of response (DoR) and disease control rate (DCR) of cardinirimab combined with nab-paclitaxel in the treatment of persistent, recurrent or metastatic cervical cancer who have previously received immune checkpoint inhibitor therapy based on RECIST v1.1 and time to response (TTR).
To evaluate the progression-free survival (PFS) and overall survival (OS) of patients with persistent, recurrent or metastatic cervical cancer who had previously received immune checkpoint inhibitor therapy with cardonilimab combined with nab-paclitaxel.
To evaluate the safety and tolerability of this combination therapy.
Exploratory objective:
To search for potential indicators in tumor tissue or peripheral blood of subjects that can predict the efficacy of cardonirimab combined with nab-paclitaxel.
Study:
NCT05824494
Study Brief:
Protocol Section:
NCT05824494