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Thomas Flaig, MD


Advanced Bladder Cancer: Combination Therapy of Copanlisib and Avelumab Focus of Phase II Trial

By: Joshua D. Madera, MD
Posted: Friday, July 21, 2023

Current therapeutic interventions for patients with advanced bladder carcinoma, including platinum-based chemotherapy followed by avelumab maintenance immunotherapy, have limited efficacy. Efforts to identify more effective treatment strategies have revealed a potential role for the PI3K inhibitor copanlisib in potentiating the PD-L1 inhibitor in preclinical models, according to a presentation given at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS4610). Therefore, Hizra Farrukh, MBBS, of Brigham and Women’s Hospital, Boston, and colleagues aim to investigate the impact of copanlisib on patients receiving avelumab maintenance therapy.

This phase II study ( identifier NCT05687721) plans to enroll 29 patients with advanced bladder carcinoma from four U.S. Department of Veterans Affairs Medical Centers. All patients will have a history of treatment with platinum-based chemotherapy and no evidence of disease progression. Patients will be administered 60 mg of intravenous copanlisib on days 1, 8, and 15 of their treatment cycle and 800 mg of intravenous avelumab on days 1 and 15. Routine imaging will occur every other treatment cycle for the first year, followed by every three cycles or as clinically necessary.

The investigators plan to focus on progression-free survival as the primary endpoint as well as overall survival, overall response rate, toxicity, and molecular correlative studies as secondary endpoints. In addition, treatment-related adverse events will be monitored regularly. Furthermore, the Response Evaluation Criteria in Solid Tumors version 1.1 criteria will be used to analyze tumor response to treatment.

Disclosure: Dr. Farrukh reported no conflicts of interest. For full disclosures of the other study authors, visit

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