Posted: Tuesday, April 19, 2022
In the randomized phase III KEYNOTE-922 trial, concurrent chemoradiotherapy with the PD-1 inhibitor pembrolizumab is being tested as a treatment option for patients with muscle-invasive bladder cancer who desire bladder preservation. Neal D. Shore, MD, of the Carolina Urologic Research Center, Myrtle Beach, South Carolina, presented the trial design and goals at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract CT564).
The double-blind KEYNOTE-992 study will enroll patients with histologically confirmed cT2–T4a nonmetastatic muscle-invasive bladder cancer. The trial aims to enroll approximately 640 patients older than age 18 who will be randomly assigned 1:1 to receive concurrent chemoradiotherapy using either 400 mg of pembrolizumab or placebo. The pembrolizumab or placebo will be administered intravenously every 6 weeks for up to nine total doses. The radiotherapy regimens allowed in the study will include conventional radiotherapy with 64 Gy at 2 Gy/fraction over 6.5 weeks or hypofractionated radiotherapy with 55 Gy at 2.75 Gy/fraction over 4 weeks. Various radiosensitizing chemotherapy regimens will be used as well, such as cisplatin monotherapy, fluorouracil plus mitomycin, and gemcitabine monotherapy.
Patients will be stratified by Eastern Cooperative Oncology Group performance status score, PD-L1 combined positive score, T stage, and geographic region. Efficacy of the regimens will be determined using cystoscopy with or without biopsy, imaging, and repeat urine cytology studies. The primary endpoint of the study is bladder-intact event-free survival, with a key secondary endpoint of overall survival. Other measures will include metastasis-free survival, time to any non–muscle-invasive bladder cancer, time to cystectomy, and safety.
Disclosure: For a full list of authors’ disclosures, visit abstractsonline.com.