NCT05790200

Cadonilimab (AK104) in the Treatment of Nasopharyngeal Carcinoma

A Phase II Clinical Study of Cadonilimab (AK104) Combined With Chemotherapy in the Treatment of PD-1 Inhibitor Resistant Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II clinical study of Cadonilimab (AK104) combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma.

Detailed description

The purpose is to evaluate the safety and effectiveness of Cadonilimab combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma as the second line and above. This study is a single-arm, phase II clinical study. It is planned to enroll about 30 patients with PD-1 inhibitor resistant nasopharyngeal carcinoma. PD-Ll CPS (\<50% vs\>50%, subjects whose PD-Ll expression could not be evaluated were classified as\<50%) was used as the stratification factor. The study will set up a safety induction period. It is planned to enroll about 6 PD-1 inhibitor resistant subjects first, and the researchers will conduct a preliminary safety assessment. If the safety and tolerability are good, and the preliminary curative effect signal is observed, it will enter the extended group period. When about 15 subjects are selected, effectiveness analysis will be carried out. If 6 of the 15 subjects with severe side effects can not tolerate, the researcher may stop the group of subjects after discussion. In case of poor safety, the researcher decided to revise or stop the study after discussion.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab	Cadonilimab (200 mg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+platinum-based chemotherapy, Q3W, 4-6 cycles), every 3 weeks (21 days) is a treatment cycle.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-09-22
• Completion: 2025-09-22
• First posted: 2023-03-30
• Last updated: 2023-03-30

Locations

1 site across 1 country: China