Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer

May 28, 2026 updated by: National Cancer Institute (NCI)

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan 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. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine).

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in the standard treatment arm to the experimental treatment arm in this population.

II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR), both confirmed and unconfirmed, complete and partial responses (CR and PR), in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

III. To compare duration of response (DOR) in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

IV. To compare disease control rate (DCR) in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive 1 of the 4 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel intravenously (IV) on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice D: Patients receive sacituzumab govitecan IV on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. (EFFECTIVE NOVEMBER 18, 2024: sacituzumab govitecan is no longer included in Arm 1 for newly enrolled patients).

ARM II: Patients receive eribulin IV over 2-5 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL)

ARM III: Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

All patients undergo computed tomography (CT), magnetic resonance imaging (MRI) throughout the trial and may undergo bone scan at the discretion of the treating physician. Patients also undergo blood and urine sample collection on the trial.

After completion of study treatment, patients are followed up every 6 months for 2 years from the date of registration, then every 12 months until death or 3 years from the date of registration

Study Type

Interventional

Enrollment (Estimated)

184

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, United States, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Mercy Hospital Fort Smith
  - Hot Springs, Arkansas, United States, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Arroyo Grande, California, United States, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Irvine, California, United States, 92612
    - UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90020
    - Keck Medicine of USC Koreatown
  - Los Angeles, California, United States, 90033
    - Los Angeles General Medical Center
  - Marysville, California, United States, 95901
    - Fremont - Rideout Cancer Center
  - Newport Beach, California, United States, 92663
    - USC Norris Oncology/Hematology-Newport Beach
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Pasadena, California, United States, 91105
    - Keck Medical Center of USC Pasadena
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - San Luis Obispo, California, United States, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - Santa Maria, California, United States, 93444
    - Mission Hope Medical Oncology - Santa Maria
- Colorado
  - Aurora, Colorado, United States, 80045
    - UCHealth University of Colorado Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80206
    - UCHealth - Cherry Creek
  - Denver, Colorado, United States, 80210
    - AdventHealth Porter
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - CommonSpirit Cancer Center Mercy
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Cancer Care and Hematology-Fort Collins
  - Greeley, Colorado, United States, 80631
    - UCHealth Greeley Hospital
  - Highlands Ranch, Colorado, United States, 80129
    - UCHealth Highlands Ranch Hospital
  - Lakewood, Colorado, United States, 80228
    - CommonSpirit Saint Anthony Hospital Cancer Center
  - Littleton, Colorado, United States, 80122
    - AdventHealth Littleton
  - Lone Tree, Colorado, United States, 80124
    - UCHealth Lone Tree Health Center
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80538
    - Medical Center of the Rockies
  - Parker, Colorado, United States, 80138
    - AdventHealth Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
- Connecticut
  - Derby, Connecticut, United States, 06418
    - Smilow Cancer Hospital-Derby Care Center
  - Fairfield, Connecticut, United States, 06824
    - Smilow Cancer Hospital Care Center-Fairfield
  - Glastonbury, Connecticut, United States, 06033
    - Smilow Cancer Hospital Care Center at Glastonbury
  - Greenwich, Connecticut, United States, 06830
    - Smilow Cancer Hospital Care Center at Greenwich
  - Guilford, Connecticut, United States, 06437
    - Smilow Cancer Hospital Care Center - Guilford
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - New Haven, Connecticut, United States, 06520
    - Yale University
  - North Haven, Connecticut, United States, 06473
    - Yale-New Haven Hospital North Haven Medical Center
  - Stamford, Connecticut, United States, 06902
    - Smilow Cancer Hospital Care Center at Long Ridge
  - Torrington, Connecticut, United States, 06790
    - Smilow Cancer Hospital-Torrington Care Center
  - Trumbull, Connecticut, United States, 06611
    - Smilow Cancer Hospital Care Center-Trumbull
  - Waterbury, Connecticut, United States, 06708
    - Smilow Cancer Hospital-Waterbury Care Center
  - Waterford, Connecticut, United States, 06385
    - Smilow Cancer Hospital Care Center - Waterford
- Florida
  - Aventura, Florida, United States, 33180
    - Mount Sinai Comprehensive Cancer Center at Aventura
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Emmett, Idaho, United States, 83617
    - Walter Knox Memorial Hospital
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
- Illinois
  - Alton, Illinois, United States, 62002
    - OSF Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, United States, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Danville, Illinois, United States, 61832
    - Carle at The Riverfront
  - DeKalb, Illinois, United States, 60115
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, United States, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Melrose Park, Illinois, United States, 60160
    - Marjorie Weinberg Cancer Center at Loyola-Gottlieb
  - Mount Vernon, Illinois, United States, 62864
    - SSM Health Good Samaritan
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Rockford, Illinois, United States, 61114
    - UW Health Carbone Cancer Center Rockford
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Springfield, Illinois, United States, 62781
    - Springfield Memorial Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Washington, Illinois, United States, 61571
    - Illinois CancerCare - Washington
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Richmond, Indiana, United States, 47374
    - Reid Health
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic - Ames
  - Ankeny, Iowa, United States, 50023
    - UI Health Care Mission Cancer and Blood - Ankeny Clinic
  - Boone, Iowa, United States, 50036
    - McFarland Clinic - Boone
  - Carroll, Iowa, United States, 51401
    - Saint Anthony Regional Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Council Bluffs, Iowa, United States, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, United States, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic - Trinity Cancer Center
  - Fort Dodge, Iowa, United States, 50501
    - UI Healthcare Mission Cancer and Blood - Fort Dodge
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic - Marshalltown
  - Waukee, Iowa, United States, 50263
    - UI Health Care Mission Cancer and Blood - Waukee Clinic
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Garden City, Kansas, United States, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, United States, 67530
    - Central Care Cancer Center - Great Bend
  - Hays, Kansas, United States, 67601
    - HaysMed
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Olathe, Kansas, United States, 66061
    - The University of Kansas Cancer Center - Olathe
  - Overland Park, Kansas, United States, 66210
    - University of Kansas Cancer Center-Overland Park
  - Overland Park, Kansas, United States, 66211
    - University of Kansas Hospital-Indian Creek Campus
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - University of Kansas Hospital-Westwood Cancer Center
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Flaget Memorial Hospital
  - Corbin, Kentucky, United States, 40701
    - Commonwealth Cancer Center-Corbin
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - London, Kentucky, United States, 40741
    - Saint Joseph London
  - Louisville, Kentucky, United States, 40202
    - Jewish Hospital
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, United States, 40215
    - Saints Mary and Elizabeth Hospital
  - Shepherdsville, Kentucky, United States, 40165
    - Jewish Hospital Medical Center South
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Louisiana Hematology Oncology Associates LLC
  - Metairie, Louisiana, United States, 70002
    - Mary Bird Perkins Cancer Center - Metairie
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Rogel Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, United States, 48116
    - University of Michigan - Brighton Center for Specialty Care
  - Brighton, Michigan, United States, 48114
    - Trinity Health Medical Center - Brighton
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health Medical Center - Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Chelsea, Michigan, United States, 48118
    - Chelsea Hospital
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital-Clinton Township
  - Dearborn, Michigan, United States, 48126
    - Henry Ford Medical Center-Fairlane
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Henry Ford Health Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Henry Ford River District Hospital
  - Escanaba, Michigan, United States, 49829
    - OSF Saint Francis Hospital and Medical Group
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48503
    - Cancer Hematology Centers - Flint
  - Grand Rapids, Michigan, United States, 49503
    - Corewell Health Grand Rapids Hospitals - Butterworth Hospital
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Henry Ford Saint John Hospital - Academic
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Henry Ford Saint John Hospital - Breast
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Henry Ford Saint John Hospital - Van Elslander
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49009
    - Beacon Kalamazoo Cancer Center
  - Lansing, Michigan, United States, 48912
    - University of Michigan Health - Sparrow Lansing
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Livonia, Michigan, United States, 48154
    - Hope Cancer Clinic
  - Macomb, Michigan, United States, 48044
    - Henry Ford Warren Hospital - Breast Macomb
  - Macomb, Michigan, United States, 48044
    - Henry Ford Saint John Hospital - Macomb Medical
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Niles, Michigan, United States, 49120
    - Corewell Health Lakeland Hospitals - Niles Hospital
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center-Columbus
  - Pontiac, Michigan, United States, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Pontiac, Michigan, United States, 48341
    - Michigan Healthcare Professionals Pontiac
  - Royal Oak, Michigan, United States, 48073
    - Corewell Health William Beaumont University Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saginaw, Michigan, United States, 48601
    - MyMichigan Medical Center Saginaw
  - Shelby, Michigan, United States, 48315
    - Henry Ford Macomb Health Center - Shelby Township
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, United States, 48764
    - MyMichigan Medical Center Tawas
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Troy, Michigan, United States, 48085
    - Corewell Health Beaumont Troy Hospital
  - Warren, Michigan, United States, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, United States, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, United States, 48093
    - Henry Ford Madison Heights Hospital - Breast
  - Warren, Michigan, United States, 48093
    - Henry Ford Health Warren Hospital
  - Warren, Michigan, United States, 48093
    - Henry Ford Warren Hospital - GLCMS
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Wyandotte, Michigan, United States, 48192
    - Henry Ford Wyandotte Hospital
  - Wyoming, Michigan, United States, 49519
    - University of Michigan Health - West
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology - Burnsville
  - Cambridge, Minnesota, United States, 55008
    - Cambridge Medical Center
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Marshall, Minnesota, United States, 56258
    - Avera Cancer Institute at Marshall
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Princeton, Minnesota, United States, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Thief River Falls, Minnesota, United States, 56701
    - Sanford Thief River Falls Medical Center
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Worthington, Minnesota, United States, 56187
    - Sanford Cancer Center Worthington
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Mercy Oncology and Hematology - Clayton-Clarkson
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Mercy Cancer Center - Cape Girardeau
  - Columbia, Missouri, United States, 65212
    - MU Health - University Hospital/Ellis Fischel Cancer Center
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, United States, 65109
    - MU Health Care Goldschmidt Cancer Center
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, United States, 64108
    - University Health Truman Medical Center
  - Kansas City, Missouri, United States, 64116
    - University of Kansas Cancer Center - Briarcliff
  - Lee's Summit, Missouri, United States, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - North Kansas City, Missouri, United States, 64116
    - University of Kansas Cancer Center at North Kansas City Hospital
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Rolla, Missouri, United States, 65401
    - Phelps Health Delbert Day Cancer Institute
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, United States, 63109
    - Mercy Infusion Center - Chippewa
  - St Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - BJC Outpatient Center at Sunset Hills
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Sletten Cancer Institute
  - Kalispell, Montana, United States, 59901
    - Logan Health Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Center
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Nebraska Cancer Specialists/Oncology Hematology West PC
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Papillion, Nebraska, United States, 68046
    - Midlands Community Hospital
- Nevada
  - Carson City, Nevada, United States, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Henderson, Nevada, United States, 89074
    - Las Vegas Urology - Green Valley
  - Henderson, Nevada, United States, 89074
    - Las Vegas Urology - Pebble
  - Henderson, Nevada, United States, 89074
    - Urology Specialists of Nevada - Green Valley
  - Henderson, Nevada, United States, 89074
    - Oncology Las Vegas - Henderson
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89109
    - Sunrise Hospital and Medical Center
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, United States, 89074
    - Las Vegas Urology - Pecos
  - Las Vegas, Nevada, United States, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, United States, 89103
    - Hope Cancer Care of Nevada
  - Las Vegas, Nevada, United States, 89106
    - Urology Specialists of Nevada - Central
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Prostate Cancer Center
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Urology - Sunset
  - Las Vegas, Nevada, United States, 89128
    - Las Vegas Urology - Cathedral Rock
  - Las Vegas, Nevada, United States, 89128
    - Las Vegas Urology - Smoke Ranch
  - Las Vegas, Nevada, United States, 89128
    - Urology Specialists of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89169
    - University Cancer Center
  - Las Vegas, Nevada, United States, 89113
    - Urology Specialists of Nevada - Southwest
  - Las Vegas, Nevada, United States, 89128
    - Oncology Las Vegas - Tenaya
  - Las Vegas, Nevada, United States, 89183
    - OptumCare Cancer Care at Fort Apache
  - Pahrump, Nevada, United States, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
- New York
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Camillus, New York, United States, 13031
    - Hematology Oncology Associates of CNY at Camillus
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
- North Carolina
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58103
    - Sanford South University Medical Center
  - Fargo, North Dakota, United States, 58103
    - Southpointe-Sanford Medical Center Fargo
  - Fargo, North Dakota, United States, 58104
    - Sanford Medical Center Fargo
- Ohio
  - Avon, Ohio, United States, 44011
    - UH Seidman Cancer Center at UH Avon Health Center
  - Beachwood, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Beavercreek, Ohio, United States, 45431
    - Indu and Raj Soin Medical Center
  - Boardman, Ohio, United States, 44512
    - Saint Elizabeth Boardman Hospital
  - Centerville, Ohio, United States, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cincinnati, Ohio, United States, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, United States, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, United States, 45415
    - Dayton Physician LLC - Englewood
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, United States, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, United States, 45840
    - Orion Cancer Care
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Franklin, Ohio, United States, 45005
    - Dayton Physicians LLC-Atrium
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians LLC-Wayne
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Kettering, Ohio, United States, 45409
    - Greater Dayton Cancer Center
  - Mentor, Ohio, United States, 44060
    - UH Seidman Cancer Center at Lake Health Mentor Campus
  - Springfield, Ohio, United States, 45504
    - Springfield Regional Cancer Center
  - Springfield, Ohio, United States, 45504
    - Springfield Regional Medical Center
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, United States, 45373
    - Dayton Physicians LLC - Troy
  - Warren, Ohio, United States, 44484
    - Saint Joseph Warren Hospital
  - Wright-Patterson Air Force Base, Ohio, United States, 45433
    - Wright-Patterson Medical Center
  - Youngstown, Ohio, United States, 44501
    - Saint Elizabeth Youngstown Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Baker City, Oregon, United States, 97814
    - Saint Alphonsus Cancer Care Center-Baker City
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Cancer Care Center-Ontario
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Erie, Pennsylvania, United States, 16505
    - UPMC Hillman Cancer Center Erie
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Harrisburg, Pennsylvania, United States, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Hazleton, Pennsylvania, United States, 18201
    - Lehigh Valley Hospital-Hazleton
  - Mechanicsburg, Pennsylvania, United States, 17050
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Hillman Cancer Center - Monroeville
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Seneca, Pennsylvania, United States, 16346
    - UPMC Cancer Center at UPMC Northwest
  - Washington, Pennsylvania, United States, 15301
    - UPMC Cancer Center-Washington
- Rhode Island
  - Westerly, Rhode Island, United States, 02891
    - Smilow Cancer Hospital Care Center - Westerly
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
- South Dakota
  - Mitchell, South Dakota, United States, 57301
    - Avera Cancer Institute - Mitchell
  - Pierre, South Dakota, United States, 57501
    - Avera Cancer Institute at Pierre
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
  - Yankton, South Dakota, United States, 57078
    - Avera Cancer Institute at Yankton
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Bristol Regional Medical Center
  - Germantown, Tennessee, United States, 38138
    - The West Clinic - Wolf River
  - Kingsport, Tennessee, United States, 37660
    - Ballad Health Cancer Care - Kingsport
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
- Texas
  - Bryan, Texas, United States, 77802
    - Saint Joseph Regional Cancer Center
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Dallas, Texas, United States, 75237
    - UT Southwestern Simmons Cancer Center - RedBird
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Houston, Texas, United States, 77030
    - Michael E DeBakey VA Medical Center
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Richardson, Texas, United States, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
- Virginia
  - Bristol, Virginia, United States, 24201
    - Ballad Health Cancer Care - Bristol
  - Norton, Virginia, United States, 24273
    - Ballad Health Cancer Care - Norton
- Washington
  - Bellevue, Washington, United States, 98004
    - Overlake Medical Center
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Enumclaw, Washington, United States, 98022
    - Saint Elizabeth Hospital
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Silverdale, Washington, United States, 98383
    - Saint Joseph Medical Center Hematology and Oncology - Silverdale
  - Tacoma, Washington, United States, 98405
    - Franciscan Research Center-Northwest Medical Plaza
  - Yakima, Washington, United States, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center
- Wisconsin
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Medical Center - Minocqua
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Saint Vincent Hospital Cancer Center at Sheboygan
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
- Wyoming
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participant must have predominant histologically or cytologically proven urothelial carcinoma in a metastatic site
Participant must have evidence of metastatic urothelial carcinoma based on CT or MRI within 28 days prior to registration
Participant must have had progression of disease following prior therapy at the discretion of the treating investigator
Participants must not require immediate central nervous system (CNS)-specific treatment, in the opinion of the treating investigator if they have active brain metastases (defined as new or progressive brain metastases) or leptomeningeal disease
Participant must have had prior systemic therapy in metastatic setting that:
- Included enfortumab vedotin
- Included a PD1/PDL1 antibody
  - NOTE: Under the discretion of the treating physician, participants who are not candidates for PD1/PDL1 antibody systemic therapy are allowed
- Any systemic therapy provided in adjuvant, neoadjuvant, or chemoradiation settings for urothelial carcinoma can be considered to be in metastatic setting, if the last day of treatment was within 12 months prior to the diagnosis of metastatic disease
Participant must have completed any planned surgery or radiation therapy prior to registration
Participant must not have unresolved toxicities from prior surgeries or radiation therapy > grade 1 at the time of registration
Participant must be ≥ 18 years of age
Participant must have Zubrod performance status 0-2
Participant must have history and physical examination within 28 days prior to registration
Participant must have complete blood count (CBC), complete metabolic panel including liver function tests, and lactate dehydrogenase (LDH) obtained within 28 days prior to registration
Participant must have adequate kidney function as evidenced by measured or calculated creatinine clearance >= 20 mL/min within 28 days prior to registration
Participant must have adequate hepatic function documented by either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (IULN) within 28 days prior to registration. If both AST and ALT are performed, both must be =< 3 x IULN. For participants with liver metastases, AST or ALT must be =< 5 x IULN
Participant must be on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration if they are known to have human immunodeficiency virus (HIV)-infection
Participants must have undetectable hepatitis B virus (HBV) viral load within 28 days prior to registration if participant has known chronic hepatitis B virus (HBV) infection
Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within 28 days prior to registration
Participants may have a prior or concurrent malignancy provided the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per the opinion of the treating investigator
Participants must not be planning to take strong or moderate CYP3A or CYP2C8 inhibitors or inducers if randomized to Arm 1 and standard of care (SOC) regimen chosen is paclitaxel or docetaxel. Participants receiving strong or moderate CYP3A- or CYP2C8 inducers must discontinue use at least 2 weeks prior to randomization
Participant must not have a known history of corrected QT (QTc) prolongation
Participants must not be pregnant or nursing due to the risk of harm to a fetus or nursing infant. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study and 6 months (females) or 3.5 months (males) after the last dose. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Participants must be offered the opportunity to participate in specimen banking as outlined
Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (standard of care chemotherapy) See Detailed Description.	Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Drug: Docetaxel Given IV Other Names: Taxotere Docecad RP56976 Taxotere Injection Concentrate RP 56976 RP-56976 Procedure: Computed Tomography Undergo CT Other Names: CT CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT Scan tomography Computerized axial tomography (procedure) Computerized Tomography (CT) scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type Drug: Gemcitabine Hydrochloride Given IV Other Names: Gemzar dFdCyd Difluorodeoxycytidine Hydrochloride Gemcitabine HCI LY-188011 LY188011 LY 188011 Procedure: Biospecimen Collection Undergo blood and urine sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Bone Scan Undergo bone scan Other Names: Bone Scintigraphy Biological: Sacituzumab Govitecan Receive IV Other Names: IMMU-132 Trodelvy Sacituzumab Govitecan-hziy hRS7-SN38 Antibody Drug Conjugate RS7-SN38 IMMU 132 IMMU132 RS7 SN38 RS7SN38
Experimental: Arm II (eribulin) Patients receive eribulin IV over 2-5 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI throughout the trial and may undergo bone scan at the discretion of the treating physician. Patients also undergo blood and urine sample collection on the trial. (CLOSED TO ACCRUAL)	Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Procedure: Computed Tomography Undergo CT Other Names: CT CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT Scan tomography Computerized axial tomography (procedure) Computerized Tomography (CT) scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type Procedure: Biospecimen Collection Undergo blood and urine sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Drug: Eribulin Mesylate Given IV Other Names: Halaven E7389 B1939 Mesylate Halichondrin B Analog ER-086526 Mesylate Procedure: Bone Scan Undergo bone scan Other Names: Bone Scintigraphy
Experimental: Arm III (eribulin, gemcitabine) Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI throughout the trial and may undergo bone scan at the discretion of the treating physician. Patients also undergo blood and urine sample collection on the trial.	Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Procedure: Computed Tomography Undergo CT Other Names: CT CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT Scan tomography Computerized axial tomography (procedure) Computerized Tomography (CT) scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type Drug: Gemcitabine Hydrochloride Given IV Other Names: Gemzar dFdCyd Difluorodeoxycytidine Hydrochloride Gemcitabine HCI LY-188011 LY188011 LY 188011 Procedure: Biospecimen Collection Undergo blood and urine sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Drug: Eribulin Mesylate Given IV Other Names: Halaven E7389 B1939 Mesylate Halichondrin B Analog ER-086526 Mesylate Procedure: Bone Scan Undergo bone scan Other Names: Bone Scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years	From date of registration to date of death due to any cause, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate Time Frame: Up to 3 years	Percentage of patients achieving at least a stable disease as best response on imaging using RECIST 1.1 criteria during treatment.	Up to 3 years
Overall response rate Time Frame: Up to 3 years		Up to 3 years
Progression free survival Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years		From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Duration of response Time Frame: Date from initial documentation of partial response or complete response to progression or death from any cause, whichever comes first, assessed up to 3 years	Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.	Date from initial documentation of partial response or complete response to progression or death from any cause, whichever comes first, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Sarmad Sadeghi, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Estimated)

August 15, 2030

Study Completion (Estimated)

August 15, 2030

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2020-07651 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180888 (U.S. NIH Grant/Contract)
S1937 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Stage IV Renal Cell Cancer AJCC v8 | Sarcomatoid Renal Cell Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Urethral Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Bladder Adenocarcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Bladder... and other conditions

United States, Puerto Rico
National Cancer Institute (NCI)

Active, not recruiting

Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Recurrent Bladder Urothelial Carcinoma | Recurrent Renal Pelvis Urothelial Carcinoma | Recurrent... and other conditions

United States, Canada
M.D. Anderson Cancer Center

Active, not recruiting

ARID1A and/or KDM6A Mutation and CXCL13 Expression

Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Recurrent Bladder Urothelial Carcinoma | Recurrent Renal Pelvis Urothelial Carcinoma | Recurrent... and other conditions

United States
National Cancer Institute (NCI)

Active, not recruiting

Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer

Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Recurrent Bladder Urothelial Carcinoma | Recurrent Renal Pelvis Urothelial Carcinoma | Recurrent Ureter Urothelial Carcinoma and other conditions

United States
National Cancer Institute (NCI)

Active, not recruiting

Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations

Recurrent Bladder Carcinoma | Metastatic Urothelial Carcinoma | Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 | Stage IV Bladder Urothelial Carcinoma AJCC v7 | Locally Advanced Bladder Urothelial Carcinoma | Metastatic Transitional Cell Carcinoma

United States
Emory University
National Cancer Institute (NCI)

Active, not recruiting

Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma

Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Renal Pelvis Cancer AJCC v8 | Stage IV Ureter Cancer... and other conditions

United States

Clinical Trials on Magnetic Resonance Imaging

M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completed

New Magnetic Resonance Imaging and Spectroscopy Software in the Improvement of Image Quality

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm

United States
Abramson Cancer Center of the University of Pennsylvania

Completed

Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma

Brain Tumor

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Terminated

Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery

Thoracic Spine Neoplasm

United States
SWOG Cancer Research Network
National Cancer Institute (NCI)

Recruiting

S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

Extensive Stage Lung Small Cell Carcinoma | Limited Stage Lung Small Cell Carcinoma | Lung Small Cell Carcinoma

United States, Canada, Korea, Republic of, Saudi Arabia, Mexico, Chile, Colombia
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completed

An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver Cancer

Advanced Adult Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma...

United States
University of California, San Francisco

Terminated

Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand

Anatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditions

United States
Mayo Clinic
National Cancer Institute (NCI); National Institute of Neurological Disorders...

Recruiting

Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Glioma | Glioblastoma | Metastatic Malignant Neoplasm in the Brain

United States
M.D. Anderson Cancer Center

Active, not recruiting

Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer

Prostate Adenocarcinoma | Prostate Carcinoma

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Withdrawn

An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases

Colorectal Carcinoma Metastatic in the Liver

United States
Wake Forest University Health Sciences
National Cancer Institute (NCI)

Completed

MRI and Cardio-Pulmonary Exercise Testing in Evaluating Exercise Intolerance in Patients With Stage I-III Breast Cancer After Chemotherapy Treatment

Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy Subject

United States

Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

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