A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-866)

Conditions

Cis-eligible 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), Number of Participants Who Discontinued Study Treatment Due to an AE, Number of Participants Who Experienced Perioperative Complications, Change in Patient-Reported Outcomes from Baseline in the Total Score of Functional Assessment of Cancer Therapy – General (FACT-G), Change in Patient-Reported Outcomes from Baseline in the Total Score of FACT-Bladder- (FACT-BI-Cys), Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI), Change in Patient-Reported Outcomes from Baseline in European Quality of Life Questionnaire (EQ-5D-5L) Visual Analog Score (VAS), Time to Deterioration (TTD) in the Total Score of FACT-G, TTD in EQ-5D-5L VAS

Related papers

No related papers found yet.

Interventions

DRUGCISPLATIN

DRUGPlacebo to Keytruda - Normal Saline Solution

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGGEMCITABINE

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), Number of Participants Who Discontinued Study Treatment Due to an AE, Number of Participants Who Experienced Perioperative Complications, Change in Patient-Reported Outcomes from Baseline in the Total Score of Functional Assessment of Cancer Therapy – General (FACT-G), Change in Patient-Reported Outcomes from Baseline in the Total Score of FACT-Bladder- (FACT-BI-Cys), Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI), Change in Patient-Reported Outcomes from Baseline in European Quality of Life Questionnaire (EQ-5D-5L) Visual Analog Score (VAS), Time to Deterioration (TTD) in the Total Score of FACT-G, TTD in EQ-5D-5L VAS	—

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), Number of Participants Who Discontinued Study Treatment Due to an AE, Number of Participants Who Experienced Perioperative Complications, Change in Patient-Reported Outcomes from Baseline in the Total Score of Functional Assessment of Cancer Therapy – General (FACT-G), Change in Patient-Reported Outcomes from Baseline in the Total Score of FACT-Bladder- (FACT-BI-Cys), Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI), Change in Patient-Reported Outcomes from Baseline in European Quality of Life Questionnaire (EQ-5D-5L) Visual Analog Score (VAS), Time to Deterioration (TTD) in the Total Score of FACT-G, TTD in EQ-5D-5L VAS

—

Countries

Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed