Atezolizumab +/− Eribulin Mesylate for Bladder Cancer
Recruiting in Palo Alto (17 mi)
+21 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Adults over 18 with recurrent, locally advanced or metastatic urothelial cancer who've had platinum-based treatment within the last year. They must have recovered from previous treatments' side effects, have a life expectancy of at least 12 weeks, and measurable disease. HIV-positive patients can join if they meet certain criteria. Exclusions include autoimmune diseases, severe heart or liver conditions, recent major surgery or vaccinations, current serious infections, history of lung problems like pneumonitis, and prior bone marrow or organ transplants.Inclusion Criteria
My cancer is advanced and cannot be removed by surgery.
I can take care of myself and am up and about more than half of my waking hours.
My cancer can be measured by tests.
Exclusion Criteria
I do not have any unmanaged ongoing illnesses.
I have had a bone marrow or organ transplant.
I have previously received specific immunotherapies or experimental drugs.
I have a history of serious heart problems.
I have had lung conditions like pulmonary fibrosis or pneumonitis.
I had a major surgery recently.
I have a significant liver condition.
Participant Groups
The trial is testing how well Atezolizumab works alone versus combined with Eribulin Mesylate in treating urothelial cancer that has returned after treatment or spread to other parts of the body. Atezolizumab is an immunotherapy drug while Eribulin Mesylate is a chemotherapy drug; both aim to stop cancer growth by different mechanisms.
2Treatment groups
Experimental Treatment
Group I: Arm II (atezolizumab, eribulin mesylate)Experimental Treatment5 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle and eribulin mesylate IV over 2-3 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and CT with contrast throughout the trial. Patients may undergo biopsy during screening and on study.
Group II: Arm I (atezolizumab)Experimental Treatment4 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and CT with contrast throughout the trial. Patients may undergo biopsy during screening and on study.
Atezolizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
🇪🇺 Approved in European Union as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Kansas Clinical Research CenterFairway, KS
University of Kansas Cancer Center-Overland ParkOverland Park, KS
City of Hope at Irvine LennarIrvine, CA
USC / Norris Comprehensive Cancer CenterLos Angeles, CA
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor