NCT06292689

A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment.

Conditions

• Vulvar and Vaginal Cancer

Interventions

Type	Name	Description
DRUG	Cardunolizumab	1. Not systematically treated: Cardunolizumab (10mg/kg) + Cisplatinum (50mg/m2)/ Carboplatinum (AUC 4-5) + Paclitaxel (175mg/m2) ± Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and then Cardunolizumab ± Bevacizumab Q3W maintenance treatment. 2. Previous systematic treatment: Cardunolizumab (10mg/kg) + Chemotherapy regimen selected by the investigator ± Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and then Cardunolizumab ± Bevacizumab Q3W maintenance treatment.

Timeline

• Start date: 2024-03-22
• Primary completion: 2026-03-22
• Completion: 2027-03-22
• First posted: 2024-03-05
• Last updated: 2024-11-21

Locations

1 site across 1 country: China