Phase II Study of Cardunolizumab With or Without Chemotherapy for Recurrent or Metastatic Vulvar and Vaginal Cancer in Women Aged 18 to 75

What this Trial Is About

Researchers are evaluating the effectiveness and safety of cardunolizumab combined with or without chemotherapy and bevacizumab in treating recurrent or metastatic vulvar and vaginal cancers that cannot be cured with radical treatment. This phase II, single-arm, multicenter prospective study aims to see how this treatment works in women with these cancers. Participants who have not received systematic treatment will receive cardunolizumab with platinum-based doublet chemotherapy, with or without bevacizumab, every three weeks for six cycles followed by maintenance treatment with cardunolizumab with or without bevacizumab every three weeks. Those previously treated with systemic therapy will receive cardunolizumab with chemotherapy chosen by the investigator and with or without bevacizumab following the same schedule. During the study, participants will undergo assessments to measure tumor response using RECIST 1.1 criteria and will be monitored for progression-free survival, overall survival, disease control rate, and duration of response up to 2 years. Adverse events will be tracked from the first dose until 90 days after the last dose. Women must provide tumor tissue samples before enrollment and will be followed for safety and treatment effects over the course of the trial, which starts in March 2024 and ends in March 2027.

A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer