Actively Recruiting
A Multicenter, Open-label, Phase II Study of AK104 Alone or with Chemotherapy in Treating Recurrent or Metastatic Vulvar Cancer
Led by Akeso · Updated on 2025-03-12
20
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AK104, an anti-PD-1 and CTLA-4 bispecific antibody, alone or combined with chemotherapy, for adults with recurrent or metastatic vulvar cancer that cannot be cured with surgery or radiotherapy. This phase II, open-label study aims to assess the treatment's effectiveness and safety in this specific group of patients. Participants receive either AK104 alone at 15 mg/kg intravenously every 3 weeks until disease progression, unacceptable side effects, completion of 2 years of treatment, or withdrawal, or a combination of AK104 at 10 mg/kg plus chemotherapy drugs paclitaxel and cisplatin or carboplatin intravenously every 3 weeks for up to 6 cycles. After chemotherapy, patients continue maintenance therapy with AK104 10 mg/kg every 3 weeks under the same stopping conditions. During the study, participants will undergo regular assessments including tumor measurements to evaluate response, monitoring for side effects, and blood tests to measure drug levels and antibodies. The primary outcome is the objective response rate measured up to about 1 year. Secondary outcomes include progression-free survival, duration of response, disease control rate, time to response, overall survival, adverse events, and drug-related antibody monitoring for up to about 2 years. The total participation period varies based on treatment duration and follow-up.
CONDITIONS
Brief Title
AK104 for Recurrent or Metastatic Vulvar Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 80 years
- ECOG performance status of 0 or 2
- Life expectancy of at least 3 months
- Histologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the vulva
- Cancer not suitable for curative surgery or radical radiotherapy
- For AK104 monotherapy group, prior failure or intolerance to at least one systemic therapy
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Adequate organ function based on laboratory tests
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
You will not qualify if you...
- Vulvar cancer with histopathological types other than squamous cell or adenosquamous carcinoma, such as melanoma or sarcoma
- Systemic or curative anti-tumor therapy within 4 weeks before first study treatment
- Prior treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Active or potentially recurrent autoimmune disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive AK104 alone or in combination with chemotherapy every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or completion of 2 years of treatment. Those in the combination group receive up to 6 cycles of chemotherapy with AK104 followed by maintenance AK104 monotherapy.
Visits every 3 weeks for treatment administration
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
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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