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Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery

Hydronephrosis Clinical Trial

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

Clinical Trial Summary

This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Clinical Trial 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. 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. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Transitional Cell
  • 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
  • Kidney Neoplasms
  • Pelvic Neoplasms
  • 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
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Urethral Urothelial Carcinoma
Clinical Trial Details
NCT number NCT02812420
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date March 7, 2017
Completion date December 31, 2024
View Details
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