Clinical trialNCT05092958Active, not recruitingPhase 3Interventional

Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study

SponsorNational Cancer Institute (NCI)Enrollment654Advanced Bladder Urothelial CarcinomaAdvanced Renal Pelvis Urothelial CarcinomaAdvanced Ureter Urothelial CarcinomaAdvanced Urethral Urothelial CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Renal Pelvis Urothelial Carcinoma+12 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Shilpa Gupta
Alliance for Clinical Trials in Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

275 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada

United States

Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Sutter Solano Medical Center/cancer Center
Vallejo, California, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants Pa
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Uf Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Cleveland Clinic-Weston
Weston, Florida, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Illinois Cancercare-Bloomington
Bloomington, Illinois, United States
Illinois Cancercare-Canton
Canton, Illinois, United States
Illinois Cancercare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush Md Anderson Cancer Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Amg Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at the Riverfront
Danville, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States

235 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Avelumab →Cabozantinib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Jun 2022
Primary completion: 15 Jul 2029
Completion: 15 Jul 2029
Last update posted: 26 Oct 2026
Registered enrollment: 654
Registry id: NCT05092958

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.