Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
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|ClinicalTrials.gov Identifier: NCT02812420|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hydronephrosis Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Infiltrating Renal Pelvis Urothelial Carcinoma, Sarcomatoid Variant Renal Pelvis Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 Stage II Renal Pelvis Cancer AJCC v7 Stage II Ureter Cancer AJCC v7 Stage II Urethral Cancer AJCC v7 Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Renal Pelvis Cancer AJCC v7 Stage III Ureter Cancer AJCC v7 Stage III Urethral Cancer AJCC v7 Stage IV Renal Pelvis Cancer AJCC v7 Stage IV Ureter Cancer AJCC v7 Stage IV Urethral Cancer AJCC v7 Ureter Urothelial Carcinoma Urethral Urothelial Carcinoma||Biological: Durvalumab Procedure: Therapeutic Conventional Surgery Biological: Tremelimumab||Phase 1|
I. To evaluate the safety and tolerability of durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer who are ineligible for neoadjuvant cisplatin-containing chemotherapies.
I. To assess immunologic/molecular responses (e.g. peripheral blood cluster of differentiation [CD] 4+inducible T-cell co-stimulator [ICOS]+ T cells) to durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer who are ineligible for neoadjuvant cisplatin-containing chemotherapies.
II. To evaluate pathologic T0 rate after neoadjuvant treatment with durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer comparing to historical data (about 10% in patients with high-risk disease).
III. To evaluate relapse-free survival (RFS) and overall survival (OS).
Patients receive tremelimumab intravenously (IV) over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.
After completion of study treatment, patients are followed up at 90 days, and then every 3 months for up 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab) Plus Anti-CTLA-4 (Tremelimumab) in Patients With Muscle-Invasive, High-Risk Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Neoadjuvant Chemotherapy|
|Actual Study Start Date :||March 7, 2017|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Treatment (tremelimumab, durvalumab)
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.
Procedure: Therapeutic Conventional Surgery
Undergo cystectomy with pelvic lymph node dissection
- Incidence of adverse events determined by extreme toxicity [ Time Frame: Up to 90 days after last dose of treatment ]
- Change in immune and molecular responses in peripheral blood and tumor tissues [ Time Frame: Baseline to 17 weeks ]
- Pathologic down-staging to T0 disease [ Time Frame: Up to 1 year ]
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): NCT02812420
|Contact: Jianjun Gaoemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jianjun Gao 713-792-2830|
|Principal Investigator: Jianjun Gao|
|Principal Investigator:||Jianjun Gao||M.D. Anderson Cancer Center|