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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

654

Participants

Timeline

Start Date

June 3, 2022

Primary Completion Date

December 10, 2025

Study Completion Date

December 10, 2025

Conditions
Advanced Bladder Urothelial CarcinomaAdvanced Renal Pelvis Urothelial CarcinomaAdvanced Ureter Urothelial CarcinomaAdvanced Urethral Urothelial CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Renal Pelvis Urothelial CarcinomaMetastatic Ureter Urothelial CarcinomaMetastatic Urethral Urothelial CarcinomaStage III Bladder Cancer AJCC v8Stage III Renal Pelvis and Ureter Cancer AJCC v8Stage III Renal Pelvis Cancer AJCC v8Stage III Ureter Cancer AJCC v8Stage III Urethral Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Stage IV Renal Pelvis and Ureter Cancer AJCC v8Stage IV Renal Pelvis Cancer AJCC v8Stage IV Ureter Cancer AJCC v8Stage IV Urethral Cancer AJCC v8
Interventions
DRUG

Avelumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo collection of blood and urine samples

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (276)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

11794

Stony Brook University Medical Center, Stony Brook

12801

Glens Falls Hospital, Glens Falls

13126

Upstate Cancer Center at Oswego, Oswego

13210

State University of New York Upstate Medical University, Syracuse

13215

SUNY Upstate Medical Center-Community Campus, Syracuse

13478

Upstate Cancer Center at Verona, Verona

14905

Arnot Ogden Medical Center/Falck Cancer Center, Elmira

17111

Penn State Health Medical Group - Andrews Patel Hematology/Oncology East, Harrisburg

18017

Lehigh Valley Hospital - Muhlenberg, Bethlehem

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

19107

Thomas Jefferson University Hospital, Philadelphia

19148

Jefferson Methodist Hospital, Philadelphia

19713

Helen F Graham Cancer Center, Newark

Medical Oncology Hematology Consultants PA, Newark

19967

Beebe South Coastal Health Campus, Millville

19971

Beebe Health Campus, Rehoboth Beach

20010

MedStar Washington Hospital Center, Washington D.C.

20892

National Institutes of Health Clinical Center, Bethesda

22601

Shenandoah Oncology PC, Winchester

23114

Bon Secours Saint Francis Medical Center, Midlothian

23116

Bon Secours Memorial Regional Medical Center, Mechanicsville

23226

Bon Secours Saint Mary's Hospital, Richmond

23229

Virginia Cancer Institute, Richmond

23235

VCU Massey Cancer Center at Stony Point, Richmond

23298

VCU Massey Comprehensive Cancer Center, Richmond

23970

VCU Community Memorial Health Center, South Hill

25304

West Virginia University Charleston Division, Charleston

27157

Wake Forest University Health Sciences, Winston-Salem

27534

Southeastern Medical Oncology Center-Goldsboro, Goldsboro

28025

Atrium Health Cabarrus/LCI-Concord, Concord

28092

Atrium Health Lincoln/LCI-Lincolnton, Lincolnton

28150

Atrium Health Cleveland/LCI-Cleveland, Shelby

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28211

Levine Cancer Institute-SouthPark, Charlotte

28262

Atrium Health University City/LCI-University, Charlotte

28277

Levine Cancer Institute-Ballantyne, Charlotte

28328

Southeastern Medical Oncology Center-Clinton, Clinton

28546

Southeastern Medical Oncology Center-Jacksonville, Jacksonville

29316

Prisma Health Cancer Institute - Spartanburg, Boiling Springs

29425

Medical University of South Carolina, Charleston

29605

Prisma Health Cancer Institute - Butternut, Greenville

Prisma Health Cancer Institute - Faris, Greenville

Prisma Health Greenville Memorial Hospital, Greenville

29615

Prisma Health Cancer Institute - Eastside, Greenville

29640

Prisma Health Cancer Institute - Easley, Easley

29650

Prisma Health Cancer Institute - Greer, Greer

29672

Prisma Health Cancer Institute - Seneca, Seneca

29732

Levine Cancer Institute-Rock Hill, Rock Hill

32610

University of Florida Health Science Center - Gainesville, Gainesville

33331

Cleveland Clinic-Weston, Weston

37701

University Cancer Specialists - Alcoa, Alcoa

37920

University of Tennessee - Knoxville, Knoxville

40207

Baptist Health Louisville, Louisville

43623

Toledo Clinic Cancer Centers-Toledo, Toledo

44111

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland

44122

South Pointe Hospital, Warrensville Heights

44124

Hillcrest Hospital Cancer Center, Mayfield Heights

44136

Cleveland Clinic Cancer Center Strongsville, Strongsville

44195

Cleveland Clinic Foundation, Cleveland

44307

Cleveland Clinic Akron General, Akron

44691

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster

44870

North Coast Cancer Care, Sandusky

44906

Cleveland Clinic Cancer Center Mansfield, Mansfield

45331

Miami Valley Cancer Care and Infusion, Greenville

45373

Upper Valley Medical Center, Troy

45409

Premier Blood and Cancer Center, Dayton

45415

Dayton Physician LLC - Englewood, Dayton

Miami Valley Hospital North, Dayton

45429

Kettering Medical Center, Kettering

45459

Miami Valley Hospital South, Centerville

46307

Northwest Cancer Center - Main Campus, Crown Point

46311

Northwest Oncology LLC, Dyer

46312

Saint Catherine Hospital, Indianapolis

46321

The Community Hospital, Munster

Women's Diagnostic Center - Munster, Munster

46342

Northwest Cancer Center - Hobart, Hobart

Saint Mary Medical Center, Hobart

46383

Northwest Cancer Center - Valparaiso, Valparaiso

48044

Henry Ford Saint John Hospital - Macomb Medical, Macomb

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

Huron Gastroenterology PC, Ypsilanti

48114

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

Trinity Health Medical Center - Brighton, Brighton

48118

Chelsea Hospital, Chelsea

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea

48154

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48188

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton

Trinity Health Medical Center - Canton, Canton

48197

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti

48341

Hope Cancer Center, Pontiac

Michigan Healthcare Professionals Pontiac, Pontiac

Newland Medical Associates-Pontiac, Pontiac

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac

48346

Hematology Oncology Consultants-Clarkston, Clarkston

Newland Medical Associates-Clarkston, Clarkston

48503

Cancer Hematology Centers - Flint, Flint

Genesee Hematology Oncology PC, Flint

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48912

University of Michigan Health - Sparrow Lansing, Lansing

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49009

Beacon Kalamazoo Cancer Center, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49085

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph

49444

Trinity Health Muskegon Hospital, Muskegon

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

University of Michigan Health - West, Wyoming

49677

Corewell Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

50010

Mary Greeley Medical Center, Ames

McFarland Clinic - Ames, Ames

50036

McFarland Clinic - Boone, Boone

50129

McFarland Clinic - Jefferson, Jefferson

50158

McFarland Clinic - Marshalltown, Marshalltown

50501

McFarland Clinic - Trinity Cancer Center, Fort Dodge

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53022

Aurora Health Care Germantown Health Center, Germantown

53024

Aurora Cancer Care-Grafton, Grafton

53051

Froedtert Menomonee Falls Hospital, Menomonee Falls

53066

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

Aurora Medical Center in Summit, Summit

53081

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan

53095

Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend

53105

Aurora Cancer Care-Southern Lakes VLCC, Burlington

53142

Aurora Cancer Care-Kenosha South, Kenosha

53149

ProHealth D N Greenwald Center, Mukwonago

53154

Drexel Town Square Health Center, Oak Creek

53188

ProHealth Waukesha Memorial Hospital, Waukesha

UW Cancer Center at ProHealth Care, Waukesha

53209

Aurora Cancer Care-Milwaukee, Milwaukee

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

Aurora Cancer Care-Milwaukee West, Wauwatosa

53227

Aurora West Allis Medical Center, West Allis

53233

Aurora Sinai Medical Center, Milwaukee

53406

Aurora Cancer Care-Racine, Racine

54017

Cancer Center of Western Wisconsin, New Richmond

54143

Aurora Bay Area Medical Group-Marinette, Marinette

54241

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers

54311

Aurora BayCare Medical Center, Green Bay

54449

Marshfield Medical Center-Marshfield, Marshfield

54476

Marshfield Medical Center - Weston, Weston

54482

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54548

Marshfield Medical Center - Minocqua, Minocqua

54701

Marshfield Medical Center-EC Cancer Center, Eau Claire

54868

Marshfield Medical Center-Rice Lake, Rice Lake

54904

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh

55101

Regions Hospital, Saint Paul

55407

Abbott-Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55905

Mayo Clinic in Rochester, Rochester

56201

Rice Memorial Hospital, Willmar

56303

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

56601

Sanford Joe Lueken Cancer Center, Bemidji

57078

Avera Cancer Institute at Yankton, Yankton

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

57105

Avera Cancer Institute, Sioux Falls

57401

Avera Cancer Institute-Aberdeen, Aberdeen

57701

Rapid City Regional Hospital, Rapid City

58122

Sanford Broadway Medical Center, Fargo

Sanford Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

60010

Advocate Good Shepherd Hospital, Barrington

60014

AMG Crystal Lake - Oncology, Crystal Lake

60045

Northwestern Medicine Lake Forest Hospital, Lake Forest

60048

AMG Libertyville - Oncology, Libertyville

Condell Memorial Hospital, Libertyville

60068

Advocate Lutheran General Hospital, Park Ridge

60115

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60123

Advocate Sherman Hospital, Elgin

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60429

Advocate South Suburban Hospital, Hazel Crest

60504

Rush-Copley Medical Center, Aurora

60515

Advocate Good Samaritan Hospital, Downers Grove

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60560

Rush-Copley Healthcare Center, Yorkville

60611

Northwestern University, Chicago

60612

Rush MD Anderson Cancer Center, Chicago

University of Illinois, Chicago

60657

Advocate Illinois Masonic Medical Center, Chicago

61021

Illinois CancerCare-Dixon, Dixon

61114

UW Health Carbone Cancer Center Rockford, Rockford

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

Illinois CancerCare-Peru, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

61520

Illinois CancerCare-Canton, Canton

61530

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

61571

Illinois CancerCare - Washington, Washington

61615

Illinois CancerCare-Peoria, Peoria

61704

Illinois CancerCare-Bloomington, Bloomington

61801

Carle Cancer Center, Urbana

61832

Carle at The Riverfront, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62269

Cancer Care Center of O'Fallon, O'Fallon

Memorial Hospital East, Shiloh

62321

Illinois CancerCare-Carthage, Carthage

62401

Carle Physician Group-Effingham, Effingham

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Illinois - Decatur, Decatur

62702

Southern Illinois University School of Medicine, Springfield

Springfield Clinic, Springfield

62781

Springfield Memorial Hospital, Springfield

62801

Centralia Oncology Clinic, Centralia

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63136

Siteman Cancer Center at Christian Hospital, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

Mercy Hospital Saint Louis, St Louis

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

63703

Saint Francis Medical Center, Cape Girardeau

64086

Saint Luke's East - Lee's Summit, Lee's Summit

64111

Saint Luke's Hospital of Kansas City, Kansas City

65212

MU Health - University Hospital/Ellis Fischel Cancer Center, Columbia

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa

75080

UT Southwestern Clinical Center at Richardson/Plano, Richardson

75237

UT Southwestern Simmons Cancer Center - RedBird, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth

85054

Mayo Clinic Hospital in Arizona, Phoenix

87106

University of New Mexico Cancer Center, Albuquerque

88011

Memorial Medical Center-Las Cruces, Las Cruces

89052

OptumCare Cancer Care at Seven Hills, Henderson

89102

OptumCare Cancer Care at Charleston, Las Vegas

89148

OptumCare Cancer Care at Fort Apache, Las Vegas

94040

Palo Alto Medical Foundation-Camino Division, Mountain View

94086

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale

94115

California Pacific Medical Center-Pacific Campus, San Francisco

94301

Palo Alto Medical Foundation Health Care, Palo Alto

94538

Palo Alto Medical Foundation-Fremont, Fremont

94589

Sutter Solano Medical Center/Cancer Center, Vallejo

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

95065

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz

95355

Memorial Medical Center, Modesto

95602

Sutter Auburn Faith Hospital, Auburn

95661

Sutter Roseville Medical Center, Roseville

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

97030

Legacy Mount Hood Medical Center, Gresham

97062

Legacy Meridian Park Hospital, Tualatin

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

98055

Valley Medical Center, Renton

98684

Legacy Cancer Institute Medical Oncology and Day Treatment, Vancouver

98686

Legacy Salmon Creek Hospital, Vancouver

32224-9980

Mayo Clinic in Florida, Jacksonville

60453-2699

Advocate Christ Medical Center, Oak Lawn

04330

Harold Alfond Center for Cancer Care, Augusta

01655

UMass Memorial Medical Center - University Campus, Worcester

03301

New Hampshire Oncology Hematology PA-Concord, Concord

03103

Solinsky Center for Cancer Care, Manchester

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07601

Hackensack University Medical Center, Hackensack

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

07960

Morristown Medical Center, Morristown

07503

Saint Joseph's Regional Medical Center, Paterson

07902

Overlook Hospital, Summit

45005-1066

Atrium Medical Center-Middletown Regional Hospital, Franklin

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

T6G 1Z2

Cross Cancer Institute, Edmonton

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH