A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

Conditions

Muscle Invasive Bladder Cancer

Brief summary

Bladder Intact Event-Free Survival (BI-EFS)

Detailed description

Overall Survival (OS), Metastasis-Free Survival (MFS), Time to Occurrence of Non–Muscle-Invasive Bladder Cancer (NMIBC), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Intervention Due to an AE, Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI), Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L), Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, TTD in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI), TTD in the VAS of the EQ-5D-5L, Time to Cystectomy

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGFLUOROURACIL

DRUGCISPLATIN

DRUGGEMCITABINE

DRUGPlacebo to keytruda - normal saline

DRUGMITOMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Bladder Intact Event-Free Survival (BI-EFS)	—

Secondary

Measure	Time frame
Overall Survival (OS), Metastasis-Free Survival (MFS), Time to Occurrence of Non–Muscle-Invasive Bladder Cancer (NMIBC), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Intervention Due to an AE, Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI), Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L), Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORT	—

Measure

Time frame

Overall Survival (OS), Metastasis-Free Survival (MFS), Time to Occurrence of Non–Muscle-Invasive Bladder Cancer (NMIBC), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Intervention Due to an AE, Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI), Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L), Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORT

—

Countries

Czechia, Estonia, France, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed