Indiana University cancer specialists just helped put Indianapolis on the global oncology map, serving as authors and investigators on a landmark clinical trial that underpins a new perioperative therapy for muscle‑invasive bladder cancer. The study tested a one‑two punch of the antibody‑drug conjugate enfortumab vedotin with the immunotherapy pembrolizumab and found far bigger survival gains than surgery alone for patients who cannot receive cisplatin. IU oncologist Nabil Adra is listed among the study’s investigators and co‑authors.
Study shows large survival gains
The results, published in The New England Journal of Medicine, found that perioperative enfortumab vedotin plus pembrolizumab significantly reduced the risk of recurrence, progression or death, roughly a 60% reduction, and cut the risk of death by about half, while producing a pathologic complete response rate of 57.1% versus 8.6% with surgery alone. The trial, known as KEYNOTE‑905/EV‑303, enrolled patients at dozens of sites around the world and delivered results that have already started to change how clinicians talk about perioperative care for this disease.
IU’s role in the trial
ClinicalTrials.gov lists the Indiana University Melvin and Bren Simon Comprehensive Cancer Center as an enrolling site for KEYNOTE‑905/EV‑303, and IU oncologist Nabil Adra appears among the paper’s authors, as noted on IU’s faculty pages. The hometown angle was also called out by the Indianapolis Business Journal, which reported on IU physicians’ role in recruiting patients and helping run the trial.
What this means for patients
The KEYNOTE‑905/EV‑303 findings helped set the stage for a regulatory milestone: the FDA approved PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a perioperative option for cisplatin‑ineligible muscle‑invasive bladder cancer in November 2025, according to a Pfizer press release. For some patients, the combination offers a potential bladder‑sparing alternative, but the study also reported substantial rates of grade‑3 and serious adverse events. That safety profile highlights the importance of receiving this regimen at experienced centers, as noted by Urology Times in its coverage of the trial.
Where Hoosiers can get care
Indiana University Health and the IU Simon Comprehensive Cancer Center are among the local centers providing bladder‑cancer care and access to clinical trials, with treatment overviews and open studies listed on IU Health patient pages. Patients who want to know whether they or a family member might benefit from the new regimen, or from trial enrollment, are urged to speak with a genitourinary oncologist to go over eligibility, potential benefits and possible risks.
What’s next
Researchers are already testing related combinations in cisplatin‑eligible patients and designing head‑to‑head comparisons that could reshape treatment guidelines, with more data expected at upcoming oncology meetings, according to coverage by Targeted Oncology. With IU physicians listed among the authors on the pivotal paper, Indianapolis is one of the cities directly involved in generating evidence that could influence bladder‑cancer care across Indiana and beyond.
