NCT02812420View on ClinicalTrials.gov

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

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

March 7, 2017

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
HydronephrosisInfiltrating Bladder Urothelial Carcinoma Sarcomatoid VariantInfiltrating Bladder Urothelial Carcinoma, Micropapillary VariantInfiltrating Bladder Urothelial Carcinoma, Plasmacytoid VariantInfiltrating Renal Pelvis Urothelial Carcinoma, Sarcomatoid VariantRenal Pelvis Urothelial CarcinomaStage II Bladder Urothelial Carcinoma AJCC v6 and v7Stage II Renal Pelvis Cancer AJCC v7Stage II Ureter Cancer AJCC v7Stage II Urethral Cancer AJCC v7Stage III Bladder Urothelial Carcinoma AJCC v6 and v7Stage III Renal Pelvis Cancer AJCC v7Stage III Ureter Cancer AJCC v7Stage III Urethral Cancer AJCC v7Stage IV Renal Pelvis Cancer AJCC v7Stage IV Ureter Cancer AJCC v7Stage IV Urethral Cancer AJCC v7Ureter Urothelial CarcinomaUrethral Urothelial Carcinoma
Interventions
BIOLOGICAL

Durvalumab

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo cystectomy with pelvic lymph node dissection

BIOLOGICAL

Tremelimumab

Given IV

Trial Locations (1)

77030

M D Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER