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Thomas Flaig, MD


Phase II INSPIRE Study: Can Chemoradiation Plus Durvalumab Improve Outcomes in Bladder Cancer?

By: Vanessa A. Carter, BS
Posted: Friday, April 8, 2022

Monika Joshi, MD, of the Penn State Cancer Institute, Hershey, Pennsylvania, and colleagues plan to combine bladder-sparing chemoradiation therapy with the monoclonal antibody durvalumab in patients with clinical stage III, node-positive urothelial carcinoma. Presented during the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (Abstract TPS594), the phase II INSPIRE trial will focus on both short-term and long-term outcomes for bladder-sparing in this population and may potentially define a new treatment strategy for stage III bladder cancer.

“Given the promise of immunotherapy in advanced bladder cancer and potential synergy between immunotherapy and radiation, INSPIRE was designed to determine the role of concurrent and adjuvant durvalumab in this patient population when treated with induction chemotherapy followed by concurrent chemoradiotherapy,” stated the investigators.

This study plans to enroll 114 patients with stage III, node-positive urothelial carcinoma who received at least three previous chemotherapy cycles without disease progression. Participants whose disease does not progress on induction chemotherapy will be randomly assigned to receive chemoradiotherapy with or without durvalumab using the following stratification factors: time of induction chemotherapy, cisplatin versus non-cisplatin regimen, lymph node size, induction chemotherapy response, and extent of transurethral resection of bladder tumor.

Primary endpoints of this study include clinical complete response, negative cystoscopy, and a bladder biopsy 8 to 10 weeks after study treatment. Secondary endpoints consist of progression-free survival, bladder-intact event-free survival, overall survival, salvage cystectomy, and toxicity rate. Individuals in the combination therapy arm who achieve a complete response or clinical benefit will receive adjuvant durvalumab for nine doses, whereas those on chemoradiotherapy alone will undergo observation. Notably, this study has been designed to determine an absolute improvement of 25% in clinical complete response between both treatment arms.

Disclosure: For full disclosures of the study authors, visit

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