Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])

PROCEDURE2 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Bladder CancerUrinary Bladder Cancer, Muscle-invasive

Phase 3

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Active, not recruitingNCT03924895

Merck Sharp & Dohme LLCUrinary Bladder Cancer, Muscle-invasive

Start: 2019-07-24End: 2027-12-15Updated: 2026-06-30

Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

CompletedNCT03924856

Merck Sharp & Dohme LLCBladder Cancer

Start: 2019-06-13End: 2026-06-11Updated: 2026-07-22

Related Papers

Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study.

Journal of Clinical Oncology2026-05-27

Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants with cisplatin-ineligible muscle-invasive bladder cancer (MIBC): An analysis of clinically relevant subgroups in KEYNOTE-905.

Journal of Clinical Oncology2026-05-27

Perioperative Enfortumab Vedotin and Pembrolizumab in Bladder Cancer.

2026-02-18

Managing potential adverse events during treatment with enfortumab vedotin + pembrolizumab in patients with advanced urothelial cancer

Frontiers in Oncology2024-04-2221 citations

Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3

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Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial

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KEYNOTE-905/EV-303: A phase 3 study to evaluate the efficacy and safety of perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC).

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Phase 3 KEYNOTE-905/EV-303: Perioperative pembrolizumab (pembro) or pembro + enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC).

Journal of Clinical Oncology2023-02-2021 citations

Enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC): Subgroup analyses of confirmed objective response rate (cORR) from EV-103 cohort K.

Journal of Clinical Oncology2023-02-2010 citations

Perioperative Pembrolizumab Therapy in Muscle-Invasive Bladder Cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303

Future Oncology2021-05-1963 citations

KEYNOTE-905/EV-303: Perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) and cystectomy compared to cystectomy alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Journal of Clinical Oncology2021-02-2021 citations

Phase Ib/II neoadjuvant (N-) pembrolizumab (P) and chemotherapy for locally advanced urothelial cancer (laUC): Final results from the cisplatin (C)- eligible cohort of HCRN GU14-188.

Journal of Clinical Oncology2020-05-2049 citations

Phase III study of perioperative pembrolizumab (pembro) plus neoadjuvant chemotherapy (chemo) versus placebo plus neoadjuvant chemo in cisplatin-eligible patients (pts) with muscle-invasive bladder cancer (MIBC): KEYNOTE-866.

Journal of Clinical Oncology2020-02-1919 citations

Phase III study of perioperative pembrolizumab (pembro) plus cystectomy versus cystectomy alone in cisplatin-ineligible patients (pts) with muscle-invasive bladder cancer (MIBC): KEYNOTE-905.

Journal of Clinical Oncology2020-02-192 citations