CHS-007-01/RTOG 3521 (Transparent trial) is a single-arm, multicenter, Phase IV study assessing the efficacy and safety combination of the anti-PD1 toripalimab and chemotherapy (cisplatin and gemcitabine) in a North America patient population of patients with nasopharyngeal carcinoma who are systemic treatment-naïve in the recurrent/metastatic setting. RTOG 3521trial’s primary objective is objective response rate. A key secondary objective is to assess the duration of response of chemo-immunotherapy followed by adjuvant toripalimab for a total duration of therapy of up to 2 years. The study, currently open to accrual since October 31,2024, aims to include 100 patients, representing various subtypes of nasopharyngeal cancer (EBV-positive or negative, HPV-positive or negative, or double-negative), all of whom are systemic therapy-naïve in the recurrent/metastatic setting. |