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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (Safety/Run-In)

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

Secondary outcome measures

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 outcome measures

Analysis of baseline tumor

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

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

Biospecimen Collection

2004

Completed Phase 2

~1730

Atezolizumab

2017

Completed Phase 3

~5860

Eribulin Mesylate

2014

Completed Phase 4

~3420

Biopsy

2014

Completed Phase 4

~850

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,251 Total Patients Enrolled

David I QuinnPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

1 Previous Clinical Trials

132 Total Patients Enrolled

Anishka A D'SouzaPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03237780 — Phase 2

Urothelial Carcinoma Research Study Groups: Arm II (atezolizumab, eribulin mesylate), Arm I (atezolizumab)

Urothelial Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03237780 — Phase 2

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03237780 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What cancer has Eribulin Mesylate been shown to be the most effective against?

"Eribulin Mesylate is commonly used to treat small cell lung cancer (sclc), but it can also be effective against other conditions such as breast, malignant neoplasms, and rna-binding protein fus."

Answered by AI

Has the government given its okay to Eribulin Mesylate?

"Eribulin Mesylate's safety is tentatively rated a 2. This score comes from it being a Phase 2 trial, where there is less supporting data for both efficacy and safety."

Answered by AI

What is the research history of Eribulin Mesylate?

"Eribulin Mesylate was first studied in 2006. Data from clinical trials shows that it has been investigated 731 times, with 394 active studies as of now. Many of these are located in Buena Park, Kansas."

Answered by AI

Could you inform me as to how many different locations are conducting this trial?

"Patients are currently being recruited from Keck Medicine of USC Buena Park in Buena Park, Kansas, Los Angeles County-USC Medical Center in Overland Park, Pennsylvania, University of Kansas Hospital-Indian Creek Campus in Irvine, Missouri and 16 other locations."

Answered by AI

What purpose does this clinical trial serve?

"The aim of this study, which will run for up to 52 weeks, is to evaluate the incidence of adverse events. Additionally, disease control rate (DCR), progression-free survival (PFS), and duration of response (DOR) will be measured as secondary outcomes. The trial will compare two arms in terms of DCR using a one-sided Mantel-Haenszel test stratified by prior platinum therapy, PD-L1 status, and other variables. PFS and DOR will be estimated using Kaplan-Meier plots."

Answered by AI

Are patients still being sought for this particular research project?

"That is accurate. The information available on clinicaltrials.gov suggests that this study, which was first advertised on 1/19/2018, is still recruiting patients. In total, 16 different medical facilities are participating in the trial and 72 patients are needed for the study."

Answered by AI