Study on Atezolizumab With or Without Eribulin Mesylate for Treating Recurrent or Advanced Urothelial Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03237780
This clinical trial is exploring the effects of combining atezolizumab, an immunotherapy drug, with or without eribulin mesylate, a chemotherapy drug, to treat urothelial cancer that has returned, spread locally, or metastasized. The study aims to determine if the combination is more effective than atezolizumab alone.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of atezolizumab, an immunotherapy drug, with or without eribulin mesylate, a chemotherapy drug, in treating patients with urothelial cancer that has come back, spread to nearby tissues, or spread to other parts of the body. Atezolizumab helps the immune system attack cancer cells, while eribulin mesylate works by stopping cancer cells from growing and spreading. The study will compare the effects of using both drugs together versus using atezolizumab alone.
Description
The study has two main goals: to ensure that atezolizumab and eribulin mesylate can be safely given together, and to compare how well the combination works against using atezolizumab alone. Researchers will look at how many patients respond to the treatment, how long the response lasts, and how the cancer progresses over time. They will also study the safety and side effects of the drug combination.
Participants will be randomly assigned to one of two groups. One group will receive atezolizumab alone, while the other group will receive both atezolizumab and eribulin mesylate. Both treatments are given through an IV, with atezolizumab administered every 21 days and eribulin mesylate given on specific days of the cycle. Patients will have regular blood tests, scans, and possibly biopsies to monitor their response to the treatment.
After completing the treatment, patients will have follow-up visits every 3 to 6 months for a year to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with advanced or metastatic urothelial cancer that cannot be surgically removed.
- Have at least one measurable tumor.
- Provide a tumor sample for analysis.
- Cancer must have progressed during or after treatment with a platinum-based chemotherapy.
- May have received up to two previous chemotherapy treatments for advanced cancer.
- Must have recovered from any side effects of previous cancer treatments.
- Stable brain metastases are allowed if treated and not requiring steroids.
- Life expectancy of at least 12 weeks.
- Good overall health with specific blood counts and organ function.
- Women must not be pregnant and must use effective birth control during and after the study.
- Men must use condoms and their partners must use effective birth control during and after the study.
- HIV-positive patients are allowed if they meet specific health criteria.
- Willing to sign informed consent and comply with study requirements.
Exclusion Criteria
- Previous bone marrow or organ transplants.
- Recent chemotherapy or radiation therapy.
- Prior treatment with certain immunotherapy drugs.
- Active infections or other serious medical conditions.
- Known brain cancer or untreated brain metastases.
- Severe allergic reactions to similar drugs.
- Other active cancers requiring treatment.
- Significant heart disease or autoimmune diseases.
- Pregnant or breastfeeding women.
- Recent major surgery or live vaccinations.
- Uncontrolled illnesses that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Keck Medicine of USC Buena Park | 90621 | Buena Park | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| Keck Medicine of USC Koreatown | 90020 | Los Angeles | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Keck Medical Center of USC Pasadena | 91105 | Pasadena | California |
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