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ACTIVE NOT RECRUITING 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

NCT05092958 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 654 participants
Start Date 2022-06-03
Est. Completion 2026-06-15
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05092958

The ClinicalTrials.gov registry entry for NCT05092958 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05092958 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Delaware, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05092958?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial