NCT05932212

AK104 for Recurrent or Metastatic Vulvar Cancer

A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Akeso · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.

Conditions

• Vulvar Cancer

Interventions

Type	Name	Description
DRUG	AK104	AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.
DRUG	AK104+ Paclitaxel+Cisplatin or Carboplatin	AK104 (10 mg/kg) + paclitaxel (175 mg/m2)+ cisplatin (50 mg/m2) or carboplatin (AUC 4-5) , IV, Q3W, for up to 6 cycles, followed by maintenance therapy of AK104 10 mg/kg Q3W until disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years treatment.

Timeline

• Start date: 2023-08-25
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2023-07-06
• Last updated: 2025-03-12

Locations

6 sites across 1 country: China