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RECRUITING
NCT05932212
PHASE2

AK104 for Recurrent or Metastatic Vulvar Cancer

Sponsor: Akeso

View on ClinicalTrials.gov

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

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.

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