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

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02901548
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.
  • Cystoscopy with Biopsy — PROCEDURE
    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.

Study Details

The purpose of this study is to test if an experimental drug called Durvalumab (Medi4736) given by intravenous (IV) infusion is effective in treating carcinoma in situ (CIS) of the bladder that no longer responds to Bacillus Calmette-Guérin (BCG) and to collect information on the safety of these drugs and whether they cause any side effects.

Key Dates

Start date
Feb 16, 2017
Status verified
Jul 2022
Primary completion
Jul 24, 2020
Completion
Sep 7, 2021

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab Plus Cystoscopy
    Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase.

Primary Outcome Measure

Complete Response Rate at 6 Months [ Time Frame: 6 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mount Sinai Medical Center MiamiMiami BeachFlorida33140-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Miami Beach, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Mount Sinai Medical Center Miami· Miami Beach, FLH. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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