Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Infiltrating Renal Pelvis Urothelial Carcinoma, Sarcomatoid Variant
- Hydronephrosis
- Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
- Stage III Renal Pelvis Cancer AJCC v7
- Stage III Urethral Cancer AJCC v7
- Stage IV Urethral Cancer AJCC v7
- Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
- Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant
- Renal Pelvis Urothelial Carcinoma
- Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
- Urethral Urothelial Carcinoma
- Stage II Renal Pelvis Cancer AJCC v7
- Stage IV Renal Pelvis Cancer AJCC v7
- Stage II Ureter Cancer AJCC v7
- Stage IV Ureter Cancer AJCC v7
- Ureter Urothelial Carcinoma
- Stage II Urethral Cancer AJCC v7
- Stage III Ureter Cancer AJCC v7
- Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. To assess immunologic/molecular responses (e.g. pe...
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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). OUTLINE: 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.
Tracking Information
- NCT #
- NCT02812420
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jianjun Gao M.D. Anderson Cancer Center
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