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Monoclonal Antibodies

Atezolizumab +/− Eribulin Mesylate for Bladder Cancer

Phase 2

Waitlist Available

Led By David I Quinn

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically- or cytologically-confirmed diagnosis of locally advanced/unresectable or metastatic transitional cell urothelial cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Must not have

Uncontrolled intercurrent illness

Prior allogeneic bone marrow transplantation or solid organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing atezolizumab with or without eribulin mesylate to see if it can help people with urothelial cancer that has come back or spread to other parts of the body.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Atezolizumab may cause immune-related reactions affecting organs and infusion responses. Eribulin Mesylate might lead to fatigue, low blood cell counts increasing infection risk and bleeding issues, numbness in extremities (neuropathy), hair loss (alopecia), nausea and constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced and cannot be removed by surgery.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer can be measured by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I have had a bone marrow or organ transplant.

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I have previously received specific immunotherapies or experimental drugs.

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I have a history of serious heart problems.

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I have had lung conditions like pulmonary fibrosis or pneumonitis.

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I had a major surgery recently.

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I have a significant liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (Safety/Run-In)

Overall response rate (probability of complete response [CR] or partial response [PR]) (Phase II)

Secondary study objectives

Analysis based on PD-L1 expression

Best overall response rate (immune-related best overall response [irBOR] rate) using the immune-related response criteria

Disease control rate (DCR: CR + PR + stable disease)

+4 more

Other study objectives

Analysis of baseline tumor

Changes in tumor based on biopsies, radiomics and circulating tumor cells

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Biospecimen Collection

2004

Completed Phase 3

~2030