NCT03520491View on ClinicalTrials.gov

A Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

April 25, 2018

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Bladder Cancer
Interventions
DRUG

Nivolumab

Nivolumab 3 mg/kg or Nivolumab 1 mg/kg

DRUG

Ipilimumab

Ipilimumab 3 mg/kg

PROCEDURE

Radical cystectomy

RC-PLND is to take place within 60 days from the last dose of treatment.(After week 10 for cohort 1, after week 11 for cohort 2, and after week 9 for cohort 3.)

Trial Locations (7)

10065

RECRUITING

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

10604

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack (All protocol activities), Commack

07920

RECRUITING

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

07748

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER