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:	Yes
Cancer Type:	Bladder Cancer	NCT ID:	NCT03924895
Trial Phases:	Phase III	Protocol IDs:	3475-905 (primary) NCI-2019-06415 2018-003809-26 EV-303 KEYNOTE-905 MK-3475-905 PHRR210911-003890
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Merck Sharp & Dohme LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT03924895

Summary

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with
pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with
muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC)
plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in
combination with pembrolizumab plus RC+PLND will achieve superior event-free survival
(EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined
positive score (CPS) were removed.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates
was changed to a secondary outcome measure.

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