Phase II Study of AK104 Alone or with Chemotherapy for Recurrent or Metastatic Vulvar Cancer

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 treatments effectiveness and safety in this specific group of patients. Participants receive either AK104 alone at 15 mgkg 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 mgkg 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 mgkg 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.

AK104 for Recurrent or Metastatic Vulvar Cancer