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NCT03513952 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma
A Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 9
- Study locations
NCT03513952 is a Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (64% lower). The trial reports 9 study locations across 8 states.
The verdict
NCT03513952, a Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 9
- Study locations
Study Summary
This phase II trial studies how well atezolizumab when given with glycosylated recombinant human interleukin-7 (CYT107) works in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced), cannot be removed by surgery (inoperable), or has spread 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. CYT107 is a biological product naturally made by the body that may stimulate the immune system to destroy tumor cells. Giving atezolizumab and CYT107 may work better in treating patients with locally advanced, inoperable, or metastatic urothelial carcinoma compared to atezolizumab alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Atezolizumab
- PROCEDURE Biopsy
- BIOLOGICAL Glycosylated Recombinant Human Interleukin-7
Study Locations (9)
Hawaii
- Straub Clinic and Hospital - Honolulu
- University of Hawaii Cancer Center - Honolulu
California
- Kaiser Permanente-Riverside - Riverside
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Louisiana
- East Jefferson General Hospital - Metairie
Missouri
- Washington University School of Medicine - St Louis
New York
- Roswell Park Cancer Institute - Buffalo
Washington
- FHCC South Lake Union - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03513952
The ClinicalTrials.gov registry entry for NCT03513952 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (64% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03513952 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Hawaii, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03513952 about?
NCT03513952 is a clinical study titled "Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma". This phase II trial studies how well atezolizumab when given with glycosylated recombinant human interleukin-7 (CYT107) works in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced), cannot be removed by surgery (inoperable), or has spread to...
What is the current status of trial NCT03513952?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2019-06-05. Estimated completion is 2024-04-01.
What conditions does trial NCT03513952 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma.
What interventions are being tested in trial NCT03513952?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Biopsy (PROCEDURE), Glycosylated Recombinant Human Interleukin-7 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03513952?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513952 being conducted?
This trial has 9 study locations across California, Florida, Hawaii, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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