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

Cannot have received: systemic anticancer therapy

Exception: therapy completed ≥ 4 weeks or 5 half-lives before first dose

Participants who have received prior systemic anticancer therapy (including study drug) within 4 weeks prior to the first dose of study treatment

Cannot have received: immunomodulatory drug

Exception: therapy completed ≥ 2 weeks before randomisation

Received an immunomodulatory drug within 2 weeks prior to randomisation

Cannot have received: radiotherapy

Exception: completed ≥ 2 weeks before first dose; palliative radiotherapy to bone lesions >7 days before first dose allowed

Received radiotherapy within 2 weeks prior to the first dose. For patients who have received radiotherapy prior to 2 weeks before the first dose, all of the following conditions must be met for enrolment: glucocorticosteroids are not required, and radiation pneumonitis, radiation hepatitis, and radiation enteritis are excluded. Patients with palliative radiotherapy to bone lesions more than 7 days from the first dose may be enrolled. Reirradiation of previously treated sites is not permitted.