Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine
Dates
study started
completion around

Description

Summary

This phase II trial studies the side effects of atezolizumab with or without eribulin mesylate and how well they work in treating patients with urothelial cancer that has come back (recurrent), spread to nearby tissues or lymph nodes (locally advanced), or spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab and eribulin mesylate may work better at treating urothelial cancer compared to atezolizumab alone.

Official Title

A Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Eribulin Mesylate in Combination With Atezolizumab Compared to Atezolizumab Alone in Subjects With Locally Advanced or Metastatic Transitional Cell Urothelial Cancer Where Cisplatin-Based Treatment is Not an Option

Details

Keywords

Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urethral Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Recurrent Bladder Urothelial Carcinoma, Recurrent Renal Pelvis Urothelial Carcinoma, Recurrent Ureter Urothelial Carcinoma, Recurrent Urethral Urothelial Carcinoma, Stage III Bladder Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8, Stage III Ureter Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Renal Pelvis Cancer AJCC v8, Stage IV Ureter Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Unresectable Bladder Urothelial Carcinoma, Unresectable Renal Pelvis Urothelial Carcinoma, Unresectable Ureter Urothelial Carcinoma, Unresectable Urethral Urothelial Carcinoma, Carcinoma, Urinary Bladder Neoplasms, Transitional Cell Carcinoma, Urethral Neoplasms, Ureteral Neoplasms, Kidney Neoplasms, Pelvic Neoplasms, Recurrence, Atezolizumab, Halichondrin B, Monoclonal Antibodies, Biopsy, Biospecimen Collection, Computed Tomography with Contrast, Eribulin Mesylate, atezolizumab, eribulin mesylate

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
Links
Related Info
ID
NCT03237780
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 72 study participants
Last Updated