NCT06664983

TPC Combined With Cadonilimab VS. TPC Alone in Anti-PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma

A Randomized Phase III Clinical Study Comparing the Combination of TPC Regimen With Cadonilimab Against the TPC Regimen Alone in Anti-PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

With the advancement of large-scale phase III clinical studies such as RATIONALE-309, JUPITER-02, and CAPTAIN-1, the GP regimen combined with immunotherapy has become the recommended first-line treatment for recurrent metastatic nasopharyngeal carcinoma. However, patients receiving first-line chemotherapy plus immunotherapy have a median progression-free survival time of only 9.6 to 21.4 months, indicating that disease progression is still inevitable after first-line chemo-immunotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma. Therefore, second or subsequent line treatment options are crucial for the management of patients with recurrent/metastatic nasopharyngeal carcinoma. In 2021, the International Society for Cancer Immunotherapy reported a multicenter, open-label, single-arm phase II clinical study of cadonilimab in patients with metastatic nasopharyngeal carcinoma who had failed second-line or subsequent chemotherapy. The data showed that among the 20 evaluable patients enrolled, the objective response rate for cadonilimab monotherapy reached 30%, with a disease control rate of 70%, and the median progression-free survival time was 3.71 months. These study results suggest that cadonilimab demonstrates encouraging anti-tumor activity and good safety in patients with metastatic nasopharyngeal carcinoma who have failed second-line or subsequent chemotherapy.

Detailed description

Cadonilimab (AK104) is humanized bispecific antibody that targets to PD-1 and CTLA-4 . Its tetravalent and no Fc binding design contribute to its high binding activity in the tumor microenvironment and improved safety profile . Recent studies have shown encouraging efficacy and manageable toxicity of cadonilimab in several different cancer types. Cadonilimab monotherapy has shown an ORR of 30% and disease control rate (DCR) of 70%, with the median disease-free survival time of 3.71 months in patients with RM-NPC at the second line setting. There is no study available to explore the role of cadonilimab in anti-PD-1 resistant RM NPC patients. Our previous study prospectively proven the superiority of TPC regimen (paclitaxel, cisplatin, and capecitabine) versus cisplatin and fluorouracil (PF) as induction treatment for patients with stage IVA NPC in NPC patients. Besides, after achieved disease control from TPC regimen induce therapy, capecitabine maintenance therapy significantly improved PFS for patients with newly diagnosed metastatic NPC with tolerate toxic . These results suggest the promising application prospect of TPC regimen in RM-NPC patients.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
DRUG	TPC chemotherapy	The TPC regimen included NAB-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle
DRUG	cadonilimab combined TPC chemotherapy	Cadonilimab was intravenously given at dose of 10 mg/kg on day 1. The TPC regimen included NAB-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-10-21
• Completion: 2026-10-21
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: China