A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer
To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment.
• Voluntary enrolment in the study with written informed consent and ability to comply with protocol requirements visits and related procedures as specified in the protocol.
• Age≥18 \& ≤75.
• Recurrent or metastatic vulvar and vaginal carcinoma not amenable to curative treatment, diagnosed histologically or cytologically, with a pathological type of squamous, adenocarcinoma or adenosquamous carcinoma.
• Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. Lesions located in previously irradiated areas are considered measurable if they show progression in such lesions.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Prior immunotherapy, targeted therapies are permitted if treatment has not been discontinued due to a grade ≥2 adverse event.
• The end of prior systemic therapy must be ≥ 4 weeks or 5 half-lives, whichever is shorter, from the first dose of this study. and the treatment-related AE returned to CTCAE 5.0 ≤ Grade 1 (except alopecia and malaise).
• All participants must provide an archived tumour tissue sample (formalin-fixed paraffin-embedded \[FFPE\] tissue wax block or a minimum of 5 unstained tumour tissue section samples, preferably newly obtained tumour tissue samples) within 2 years prior to randomisation.
⁃ Has adequate organ function.
⁃ Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
⁃ Ability to understand and sign written informed consent and to comply with programme visits and related procedures.