AK104 for Recurrent or Metastatic Vulvar Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 25, 2023

Primary Completion Date

December 15, 2025

Study Completion Date

December 15, 2025

Conditions
Vulvar Cancer
Interventions
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.

Trial Locations (6)

110042

RECRUITING

Liaoning Cancer Hospital & Insitut, Shenyang

300000

RECRUITING

Tianjin medical university Cancer Institut & Hospital, Tianjin

310022

NOT_YET_RECRUITING

Zhejiang Cancer Hospital, Hangzhou

350000

RECRUITING

Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital, Fuzhou

510000

RECRUITING

Sun Yant-Sen Memorial Hospital, Guangzhou

050000

NOT_YET_RECRUITING

The Fourth Hospital of Hebei Medical University, Shijiangzhuang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Akeso

INDUSTRY