Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder
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|ClinicalTrials.gov Identifier: NCT02901548|
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma in Situ of Bladder Bladder Cancer||Drug: Durvalumab Procedure: Cystoscopy with Biopsy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Check Point Inhibitor, Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refractory Urothelial Carcinoma in Situ (CIS) of the Bladder|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
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.
Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.
Other Name: Medi4736
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.
- Complete Response Rate at 6 Months [ Time Frame: 6 Months ]Complete Response Rate at month six based on the week 26 mapping biopsy in BCG refractory CIS urothelial bladder cancer. The absence of CIS of bladder on the mapping biopsies after pathological review would be considered complete response to treatment.
- Complete Response Rate at 24 Months [ Time Frame: 24 Months ]Complete Response Rate at month 24 based on the week 104 mapping biopsy in BCG refractory CIS urothelial bladder cancer. The absence of CIS of bladder on the mapping biopsies after pathological review would be considered complete response to treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901548
|Contact: Jingsong Zhang, M.D., Ph.D.||email@example.com|
|United States, Florida|
|Mount Sinai Medical Center Miami||Recruiting|
|Miami Beach, Florida, United States, 33140|
|Contact: Jenny Camus firstname.lastname@example.org|
|Principal Investigator: Alan Nieder, MD|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Natalie Burgess 813-745-4075 email@example.com|
|Contact: Jingsong Zhang, M.D., Ph.D. 813-745-1363 firstname.lastname@example.org|
|Principal Investigator: Jingsong Zhang, M.D., Ph.D.|
|Principal Investigator: Wade Sexton, M.D.|
|Sub-Investigator: Mayer Fishman, M.D., Ph.D.|
|Sub-Investigator: Scott Gilbert, M.D.|
|Sub-Investigator: Michael Poch, M.D.|
|Sub-Investigator: Julio Pow-Sang, M.D.|
|Sub-Investigator: Philippe Spiess, M.D.|
|Principal Investigator:||Jingsong Zhang, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|