Mamta Parikh is testing Selinexor and Pembrolizumab in patients with cisplatin-ineligible urothelial carcinoma
This phase Ib/II trial finds the best dose of selinexor and its effect with pembrolizumab in treating patients with urothelial carcinoma that are not eligible to receive the chemotherapy drug cisplatin, or have been given cisplatin and the cancer has gotten worse. Patients must also have urothelial carcinoma that has spread locally, near where it started (locally advanced), or has spread to other parts of the body (metastatic). Selinexor may stop the growth of tumor cells by blocking a protein, called XPO1, that is needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving selinexor and pembrolizumab may kill more tumor cells.
It is planned to include 12 participants. Actual study start date is April 8, 2021. The researchers expect to complete the study by May 1, 2024.
One primary outcome measure is Objective response rate (ORR) (Phase II), ORR, calculated as the total number of patients with a confirmed complete response or partial response, will be reported as a percentage of total evaluable patients. Response will be reported using Response Evaluation Criteria in Solid Tumor 1.1 definitions. ORR will be summarized by exact binomial 95% confidence intervals (CI).
The location of the study is Sacramento, United States. Further details, such as inclusion and exclusion criteria, and investigators' details can be found here https://ichgcp.net/clinical-trials-registry/NCT04856189.
