NCT03504163 - Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)] | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 27, 2018

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions

Bladder Cancer

Interventions

DRUG

Pembrolizumab (MK-3475)

Pembrolizumab (MK-3475) will be administered as a 400 mg intravenous (IV) infusion at 6- week intervals for 9 doses over a 48-week.

DRUG

Bacillus Calmette-Guérin (BCG)

Intravesical BCG will be administrated once per week over a 6-week period as induction therapy, followed by maintenance BCG consistent with standard clinical practice

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering West Harrison (All Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack (All protocol activities), Commack

07748

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (All protocol activities), Montvale

All Listed Sponsors

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER