Actively Recruiting
AK104 for Recurrent or Metastatic Vulvar Cancer
Led by Akeso · Updated on 2025-03-12
20
Participants Needed
6
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AK104 for Recurrent or Metastatic Vulvar Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 80 years
- ECOG performance status of 0 or 2
- Life expectancy of at least 3 months
- Histologically confirmed vulvar squamous cell carcinoma or adenosquamous carcinoma
- Cancer not suitable for curative surgery or radical radiotherapy
- For Cohort A, prior failure on at least one systemic therapy or intolerance to standard therapy
- At least one measurable tumor lesion per RECIST v1.1
- Adequate organ function based on lab tests
- Negative serum pregnancy test for females of childbearing potential before first treatment
- Agreement to use effective contraception for females of childbearing potential
You will not qualify if you...
- Other histopathological types of vulvar cancer such as melanoma or sarcoma
- Systemic or curative anti-tumor therapy within 4 weeks before first treatment
- Previous treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4)
- Active or potentially recurrent autoimmune disease
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
2
Sun Yant-Sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
The Fourth Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China, 050000
Not Yet Recruiting
4
Liaoning Cancer Hospital & Insitut
Shenyang, Liaoning, China, 110042
Actively Recruiting
5
Tianjin medical university Cancer Institut & Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
T
Ting Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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