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{{header-clinical-trials-navigation}} A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304) Condition: Muscle Invasive Bladder Cancer Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT04700124 Sponsor: Merck Sharp & Dohme Corp. Phase: Phase 3 Eligibility: Age: […]

(UroToday.com) Following two presentations regarding novel treatment approaches for patients with advanced renal cell carcinoma in the Kidney and Bladder Poster Discussion session at the 2021 American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, Dr. Guillermo de Velasco provided a discussant overview of these data and the rapidly moving disease space of renal cell carcinoma […]

(UroToday.com) The standard of care for patients with muscle-invasive bladder cancer remains neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy and pelvic lymph node dissection (RC+PLND). However, many patients will experience disease recurrence, progression, and bladder cancer-related death following neoadjuvant chemotherapy and RC+PLND. This has led to interest in both adjuvant therapy and improved neoadjuvant therapies.

(UroToday.com) In EV-301, a randomized, open-label phase 3 study, enfortumab vedotin, a Nectin-4–directed therapy, significantly prolonged median overall survival by ̃3.9 months and reduced the risk of death by 30% compared with standard chemotherapy (docetaxel, paclitaxel, or vinflunine) in patients with previously treated locally advanced/metastatic urothelial carcinoma.1 Characterizing patient-reported outcomes using a systematic process with a validated […]

(UroToday.com) Patients undergoing radical surgery for muscle-invasive urothelial carcinoma face a high risk of disease recurrence. Recurrence is associated with worse survival, but its effect on health-related quality of life (HRQoL) is unclear. In the ongoing phase 3 CheckMate 274 trial, adjuvant nivolumab monotherapy significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma who had […]

(UroToday.com) Significant unmet need remains for people with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma. In the first-line setting, carboplatin-based regimens have demonstrated poor tolerability, modest objective response rate, and limited durability. PD-1/PD-L1 inhibitors demonstrate durable responses, however, only a minority of patients achieve a response (ORR 24-29%). Enfortumab vedotin is an antibody-drug conjugate delivering the […]

(UroToday.com) Approximately half of the patients with advanced urothelial carcinoma in the United States are cisplatin-ineligible. Of note, cisplatin-ineligible, platinum-naive patients with locally advanced or metastatic urothelial carcinoma who progress on or after anti-PD-1/L1 treatment have a poor prognosis and few treatment options. Enfortumab vedotin, a Nectin-4-directed antibody-drug conjugate, demonstrated an overall survival benefit in patients […]

(UroToday.com) The phase 3 JAVELIN Bladder 100 trial, which enrolled patients with advanced urothelial carcinoma that had not progressed with first-line platinum-containing chemotherapy, showed that maintenance therapy with avelumab + best supportive care significantly prolonged overall survival (OS) compared with best supportive care alone (HR 0.69, 95% CI 0.56 to 0.86; 1-sided p = 0.0005).1 However, the […]

(UroToday.com) Androgen deprivation therapy (ADT) is a cornerstone of prostate cancer treatment and is usually achieved with luteinizing hormone-releasing hormone (LHRH) agonists or gonadotropin-releasing hormone (GnRH) antagonists. Relugolix is a first-in-class FDA-approved, oral, highly selective, GnRH receptor antagonist that is given once daily with an effective half-life of 25 hours for the treatment of adult men […]

(UroToday.com) Dr. Arul Chinnaiyan, Director, Michigan Center for Translational Pathology, S.P. Hicks Endowed Professor of Pathology was awarded the Science of Oncology Award for facilitating the delivery of precision medicine and advancing the field of cancer genomics and functional biology. In this lecture, Dr. Arul Chinnaiyan highlighted some of the accomplishments of his group over […]