Clinical Research Directory
Browse clinical research sites, groups, and studies.
AK104 for Recurrent or Metastatic Vulvar Cancer
Sponsor: Akeso
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.
Official title: A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-08-25
Completion Date
2025-12-15
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
AK104
AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.
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.
Locations (6)
Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yant-Sen Memorial Hospital
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China
Liaoning Cancer Hospital & Insitut
Shenyang, Liaoning, China
Tianjin medical university Cancer Institut & Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China