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NCT03237780 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer
A Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT03237780: Active Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03237780 is a Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants, below the 120-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03237780, a Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Tables will be created to summarize the numbers of patients who experienced toxicities by arm, toxicity system, type, grade and attribution. If helpful, cumulative incidence curves will be constructed to summarize the onset of selected adverse events.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Atezolizumab
- PROCEDURE Biopsy Procedure
- PROCEDURE Computed Tomography with Contrast
- DRUG Eribulin Mesylate
Study Locations (20)
California
- Keck Medicine of USC Buena Park - Buena Park
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- Keck Medicine of USC Koreatown - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
- City of Hope Upland - Upland
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Missouri
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital - North Kansas City
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-07-20 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What the registry record for NCT03237780 still lists
NCT03237780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 120-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (40% lower).
The record links to 10 conditions, with Metastatic Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03237780 names 20 study sites across 4 states, led by California, Kansas, Missouri.
Frequently Asked Questions
What is clinical trial NCT03237780 about?
NCT03237780 is a clinical study titled "Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer". 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...
What is the current status of trial NCT03237780?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2018-07-20. Estimated completion is 2027-06-30.
What conditions does trial NCT03237780 study?
This clinical trial studies the following conditions: Metastatic Bladder Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma.
What interventions are being tested in trial NCT03237780?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Atezolizumab (DRUG), Biopsy Procedure (PROCEDURE), Computed Tomography with Contrast (PROCEDURE), Eribulin Mesylate (DRUG).
Who is sponsoring clinical trial NCT03237780?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03237780 being conducted?
This trial has 20 study locations across Alabama, California, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03237780's enrollment target sits among peer trials
72 6th of 13 higher than 8 of 13 other Metastatic Bladder Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Bladder Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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