Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

February 10, 2016

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Bladder Cancer
Interventions
BIOLOGICAL

Pembrolizumab

Participants with CIS with or without papillary tumors (Cohort A) and participants with papillary tumors only, without CIS (Cohort B) receive pembrolizumab 200mg via IV infusion once every 3 weeks for up to 35 administrations

BIOLOGICAL

Pembrolizumab/vibostolimab coformulation

Participants with CIS with or without papillary tumors (Cohort C) receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion once every 3 weeks for up to 35 administrations

BIOLOGICAL

Favezelimab/pembrolizumab coformulation

Participants with CIS with or without papillary tumors (Cohort C) receive favezelimab/pembrolizumab (coformulation of 800mg favezelimab and 200 mg pembrolizumab) via IV infusion once every 3 weeks for up to 35 administrations

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY