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)

Conditions

Muscle Invasive Bladder Cancer

Brief summary

Event-Free Survival (EFS)

Detailed description

Pathologic Complete Response (pCR) Rate, 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 Role Functioning Scale per EORTC QLQ-C30, TTD in the Urinary, Bowel and Sexual Domains per BCI, TTD in the EQ-5D-5L VAS

Related papers

No related papers found yet.

Interventions

DRUGENFORTUMAB VEDOTIN

DRUGGEMCITABINE

DRUGCISPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-Free Survival (EFS)	—

Secondary

Measure	Time frame
Pathologic Complete Response (pCR) Rate, 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 Role Functioning Scale per EORTC QLQ-C30, TTD in the Urinary,	—

Measure

Time frame

Pathologic Complete Response (pCR) Rate, 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 Role Functioning Scale per EORTC QLQ-C30, TTD in the Urinary,

—

Countries

Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed