Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

Official Title

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)

Summary:

The purpose of this study is to assess the antitumour efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

Trial Description

Primary Outcome:

• Pathologic Complete Response (pCR) Rate
• Event-Free Survival (EFS)

• Overall Survival (OS)
• Disease Free Survival (DFS)
• Pathologic Downstaging (pDS) Rate
• Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
• Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
• Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
• Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
• Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
• Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)
• Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30)
• TTD in the Physical Functioning Scale per EORTC QLQ-C30
• TTD in the Urinary, Bowel and Sexual Domains per BCI
• TTD in the EQ-5D-5L VAS

View this trial on ClinicalTrials.gov