Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder

PHASE2TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

February 16, 2017

Primary Completion Date

July 24, 2020

Study Completion Date

September 7, 2021

Conditions
Carcinoma in Situ of BladderBladder Cancer
Interventions
DRUG

Durvalumab

Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.

PROCEDURE

Cystoscopy with Biopsy

Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.

Trial Locations (2)

33140

Mount Sinai Medical Center Miami, Miami Beach

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER