AK104 for Recurrent or Metastatic Vulvar Cancer

Recruiting now · Phase 2

Conditions studied: Vulvar Cancer

In brief

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.

Key facts

Study ID

NCT05932212

Run by

Akeso

People needed

20

Starts

2023-08-25

Expected to finish

2025-12-15

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age >=18 and <=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy.
• For Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy.
• At least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception

You may not qualify if…

• Subjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc.
• Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration.
• Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.).
• Active or potentially recurrent autoimmune disease.

Where it is running

• Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yant-Sen Memorial Hospital — Guangzhou, Guangdong, China (enrolling)
• Liaoning Cancer Hospital & Insitut — Shenyang, Liaoning, China (enrolling)
• Tianjin medical university Cancer Institut & Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiangzhuang, Hebei, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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