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PhIIEribulin Mesylate Combo w/Atezolizumab to Atezo in Sub w/LocAdv or Met TCUC Where Cis Tx Not Opt

Nataliya Mar


A Study On:

  • Urinary Bladder

Status:

  • Open

Eligibility

Adults

Interested in joining this trial?

Official Title

A Randomized, Phase II 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

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 and lymph nodes (locally advanced), or 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.


Eligibility

You can join if...

Inclusion criteria:

-Histologically- or cytologically-confirmed diagnosis of locally advanced/unresectable (inoperable or not amenable to surgical treatment) and/or metastatic transitional cell urothelial cancer of the renal pelvis, ureter, urinary bladder, or urethra

-May have received up to two prior lines of chemotherapy for advanced disease

-Life expectancy of >= 12 weeks

Exclusion criteria:

-Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

-Patients who have had chemotherapy within 3 weeks or radiotherapy or targeted therapy 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier

-Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents or eribulin

Get in touch with our study team