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NCT05092958 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
A Phase 3 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 654
- Enrollment target
- 20
- Study locations
NCT05092958: Active Phase 3 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05092958 is a Phase 3 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 654 participants, above the 75-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (772% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05092958, a Phase 3 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 654 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.
Primary Outcome
Subgroup analyses will be done using a stratified Cox model that includes the treatment arm assignment as an explanatory variable and a separate model will be generated for each level for the subgroup of interest.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- DRUG Cabozantinib S-malate
- DRUG Avelumab
Study Locations (20)
California
- Sutter Auburn Faith Hospital - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Palo Alto Medical Foundation-Fremont - Fremont
- Memorial Medical Center - Modesto
- Palo Alto Medical Foundation-Camino Division - Mountain View
- Palo Alto Medical Foundation Health Care - Palo Alto
- Sutter Roseville Medical Center - Roseville
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- California Pacific Medical Center-Pacific Campus - San Francisco
- Palo Alto Medical Foundation-Santa Cruz - Santa Cruz
- Palo Alto Medical Foundation-Sunnyvale - Sunnyvale
- Sutter Solano Medical Center/Cancer Center - Vallejo
Delaware
- Beebe South Coastal Health Campus - Millville
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Beebe Health Campus - Rehoboth Beach
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2022-06-03 |
| Est. Completion | 2026-06-15 |
| Phase | Phase 3 |
What the registry record for NCT05092958 still lists
NCT05092958 is an interventional study that assigns participants to a tested intervention. The registered 654 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (772% higher).
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.
NCT05092958 names 20 study sites across 5 states, led by California, Delaware, Arizona.
Frequently Asked Questions
What is clinical trial NCT05092958 about?
NCT05092958 is a clinical study titled "Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study". This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocki...
What is the current status of trial NCT05092958?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2022-06-03. Estimated completion is 2026-06-15.
What conditions does trial NCT05092958 study?
This clinical trial studies the following conditions: Metastatic Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Stage III Bladder Cancer AJCC v8, Metastatic Renal Pelvis Urothelial Carcinoma.
What interventions are being tested in trial NCT05092958?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Cabozantinib S-malate (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT05092958?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05092958 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05092958's enrollment target sits among peer trials
654 1st of 13 higher than 13 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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