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Phase III Trial to Study Triplet Immunotherapy Regimen in Bladder Cancer

By: Vanessa A. Carter, BS
Posted: Wednesday, April 6, 2022

The phase III VOLGA trial, being conducted by Thomas Powles, MD, PhD, FCRP, of Barts Cancer Centre, Queen Mary University of London, and colleagues, is actively recruiting patients with cisplatin-ineligible muscle-invasive bladder cancer to receive the anti–PD-L1 antibody durvalumab and the monoclonal antibody enfortumab vedotin-ejfv with or without the anti–CTLA-4 antibody tremelimumab. These investigators presented their early study plans during the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (Abstract TPS579).

“Targeted cytotoxic antibody-drug conjugates are known to have the potential to induce immunogenic tumor cell death, which promotes activation and recruitment of immune cells,” the study authors stated. “Thus, we hypothesize that enfortumab vedotin in combination with PD-L1 inhibition, with or without CTLA-4 inhibition, may improve outcomes in patients with muscle-invasive bladder cancer by downstaging of disease before cystectomy and that adjuvant therapy with durvalumab or durvalumab plus tremelimumab may further improve the time to disease relapse.”

This open-label, multicenter trial will enroll approximately 830 adults with cisplatin-ineligible, muscle-invasive bladder cancer who have clinical stage T2 to T4a N0 to N1 M0 disease. Following radical cystectomy, participants will be randomly assigned to one of three arms and receive three cycles of neoadjuvant therapy in the following subgroups: durvalumab plus tremelimumab plus enfortumab vedotin (arm 1); durvalumab plus enfortumab vedotin (arm 2); and no adjuvant treatment (arm 3).

The primary endpoints of this study include pathologic complete response and event-free survival. Secondary endpoints consist of disease-free survival, overall survival, disease-specific survival, immunogenicity, pharmacokinetics, and pathologic downstaging rate to less than stage pT2.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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