drugset / Trial / NCT05932212

AK104 for Recurrent or Metastatic Vulvar Cancer

NCT05932212 ↗

Phase 2 Recruiting 20 enrolled Akeso
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-25
Primary completion
2025-12-15
Completion
2025-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 10 mg/kg Intravenous
Subject Cadonilimab Monoclonal antibody 15 mg/kg Intravenous
Subject Carboplatin Small molecule 4 unknown Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 50 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous

Indications