A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

March 17, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Bladder Urothelial CarcinomaStage III Bladder Cancer AJCC v8
Interventions
PROCEDURE

Biopsy of Bladder

Undergo bladder biopsy

PROCEDURE

Biospecimen Collection

Undergo tumor tissue and blood sample collection

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Cystoscopy

Undergo cystoscopy

BIOLOGICAL

Durvalumab

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mitomycin

Given IV

OTHER

Patient Observation

Undergo observation

RADIATION

Radiation Therapy

Undergo radiation therapy

Trial Locations (216)

18017

Lehigh Valley Hospital - Muhlenberg, Bethlehem

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

18301

Pocono Medical Center, East Stroudsburg

19317

Christiana Care Health System-Concord Health Center, Chadds Ford

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

20016

Sibley Memorial Hospital, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

24112

Sovah Health Martinsville, Martinsville

29303

Spartanburg Medical Center, Spartanburg

29341

Gibbs Cancer Center-Gaffney, Gaffney

29379

SMC Center for Hematology Oncology Union, Union

29651

Gibbs Cancer Center-Pelham, Greer

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

33140

Mount Sinai Medical Center, Miami Beach

33308

Holy Cross Hospital, Fort Lauderdale

37920

University of Tennessee - Knoxville, Knoxville

40202

Jewish Hospital, Louisville

40207

Baptist Health Louisville, Louisville

40245

UofL Health Medical Center Northeast, Louisville

40504

Saint Joseph Radiation Oncology Resource Center, Lexington

40509

Saint Joseph Hospital East, Lexington

45220

Good Samaritan Hospital - Cincinnati, Cincinnati

45242

Bethesda North Hospital, Cincinnati

48093

Henry Ford Health Warren Hospital, Warren

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

48114

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

Trinity Health Medical Center - Brighton, Brighton

48118

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

48236

Henry Ford Health Saint John Hospital, Detroit

48341

Michigan Healthcare Professionals Pontiac, Pontiac

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

MyMichigan Medical Center Saginaw, Saginaw

48912

University of Michigan Health - Sparrow Lansing, Lansing

50010

Mary Greeley Medical Center, Ames

McFarland Clinic - Ames, Ames

50266

Mercy Medical Center-West Lakes, West Des Moines

50309

Iowa Methodist Medical Center, Des Moines

UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines

50314

Broadlawns Medical Center, Des Moines

Mercy Medical Center - Des Moines, Des Moines

UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

50325

Mercy Cancer Center-West Lakes, Clive

UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive

50801

Greater Regional Medical Center, Creston

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

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

54806

Duluth Clinic Ashland, Ashland

Northwest Wisconsin Cancer Center, Ashland

54868

Marshfield Medical Center-Rice Lake, Rice Lake

55072

Essentia Health Sandstone, Sandstone

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55746

Essentia Health Hibbing Clinic, Hibbing

55792

Essentia Health Virginia Clinic, Virginia

55805

Essentia Health Cancer Center, Duluth

Essentia Health Saint Mary's Medical Center, Duluth

Miller-Dwan Hospital, Duluth

56401

Essentia Health Saint Joseph's Medical Center, Brainerd

56636

Essentia Health - Deer River Clinic, Deer River

59101

Billings Clinic Cancer Center, Billings

59405

Benefis Sletten Cancer Institute, Great Falls

Great Falls Clinic, Great Falls

59715

Bozeman Health Deaconess Hospital, Bozeman

59804

Community Medical Center, Missoula

59901

Logan Health Medical Center, Kalispell

60045

Northwestern Medicine Lake Forest Hospital, Lake Forest

60115

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60141

Edward Hines Jr VA Hospital, Hines

60153

Loyola University Medical Center, Maywood

60504

Rush-Copley Medical Center, Aurora

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Northwestern University, Chicago

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

Illinois CancerCare-Peru, Peru

Valley Radiation Oncology, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg, Galesburg

Western Illinois Cancer Treatment Center, 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

OSF Saint Francis Radiation Oncology at Pekin, Pekin

61615

Illinois CancerCare-Peoria, Peoria

OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61704

Illinois CancerCare-Bloomington, Bloomington

61801

Carle Cancer Center, Urbana

The Carle Foundation Hospital, Urbana

61832

Carle at The Riverfront, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62269

Cancer Care Center of O'Fallon, O'Fallon

62321

Illinois CancerCare-Carthage, Carthage

62401

Carle Physician Group-Effingham, Effingham

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Illinois - Decatur, Decatur

Decatur Memorial Hospital, Decatur

62702

Southern Illinois University School of Medicine, Springfield

Springfield Clinic, Springfield

62781

Springfield Memorial Hospital, Springfield

62801

Centralia Oncology Clinic, Centralia

62864

SSM Health Good Samaritan, Mount Vernon

62902

Memorial Hospital of Carbondale, Carbondale

62918

SIH Cancer Institute, Carterville

63011

Mercy Oncology and Hematology - Clayton-Clarkson, Ballwin

63080

Missouri Baptist Sullivan Hospital, Sullivan

63110

Washington University School of Medicine, St Louis

63127

BJC Outpatient Center at Sunset Hills, Sunset Hills

63128

Mercy Hospital South, St Louis

63129

Siteman Cancer Center-South County, St Louis

63131

Missouri Baptist Medical Center, 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

63640

Parkland Health Center - Farmington, Farmington

63670

Sainte Genevieve County Memorial Hospital, Sainte Genevieve

63703

Mercy Cancer Center - Cape Girardeau, Cape Girardeau

Saint Francis Medical Center, Cape Girardeau

64506

Heartland Regional Medical Center, Saint Joseph

64804

Mercy Hospital Joplin, Joplin

65109

MU Health Care Goldschmidt Cancer Center, Jefferson City

65401

Mercy Clinic-Rolla-Cancer and Hematology, Rolla

Phelps Health Delbert Day Cancer Institute, Rolla

65804

Mercy Hospital Springfield, Springfield

65807

CoxHealth South Hospital, Springfield

68122

Alegent Health Immanuel Medical Center, Omaha

68124

Alegent Health Bergan Mercy Medical Center, Omaha

68130

Alegent Health Lakeside Hospital, Omaha

68131

Creighton University Medical Center, Omaha

68803

Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island

68847

CHI Health Good Samaritan, Kearney

70006

East Jefferson General Hospital, Metairie

LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie

70112

Louisiana State University Health Science Center, New Orleans

University Medical Center New Orleans, New Orleans

71913

CHI Saint Vincent Cancer Center Hot Springs, Hot Springs

72903

Mercy Hospital Fort Smith, Fort Smith

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73120

Mercy Hospital Oklahoma City, Oklahoma City

77802

Saint Joseph Regional Cancer Center, Bryan

80122

AdventHealth Littleton, Littleton

80138

AdventHealth Parker, Parker

80210

AdventHealth Porter, Denver

80228

Saint Anthony Hospital, Lakewood

80501

Longmont United Hospital, Longmont

80907

Penrose-Saint Francis Healthcare, Colorado Springs

Rocky Mountain Cancer Centers-Penrose, Colorado Springs

81004

Saint Mary Corwin Medical Center, Pueblo

82801

Welch Cancer Center, Sheridan

83301

Saint Luke's Cancer Institute - Twin Falls, Twin Falls

83605

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83619

Saint Luke's Cancer Institute - Fruitland, Fruitland

83642

Idaho Urologic Institute-Meridian, Meridian

Saint Luke's Cancer Institute - Meridian, Meridian

83687

Saint Alphonsus Cancer Care Center-Nampa, Nampa

Saint Luke's Cancer Institute - Nampa, Nampa

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

83712

Saint Luke's Cancer Institute - Boise, Boise

83814

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

Kootenai Clinic Cancer Services - Post Falls, Post Falls

87106

University of New Mexico Cancer Center, Albuquerque

91505

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank

94304

VA Palo Alto Health Care System, Palo Alto

97015

Clackamas Radiation Oncology Center, Clackamas

Providence Cancer Institute Clackamas Clinic, Clackamas

97132

Providence Newberg Medical Center, Newberg

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

97420

Bay Area Hospital, Coos Bay

97701

Saint Charles Health System, Bend

98026

Swedish Cancer Institute-Edmonds, Edmonds

98029

Swedish Cancer Institute-Issaquah, Issaquah

98107

Swedish Medical Center-Ballard Campus, Seattle

98122

Swedish Medical Center-First Hill, Seattle

98166

Highline Medical Center-Main Campus, Burien

98201

Providence Regional Cancer Partnership, Everett

98225

PeaceHealth Saint Joseph Medical Center, Bellingham

98284

PeaceHealth United General Medical Center, Sedro-Woolley

98383

Saint Michael Cancer Center, Silverdale

98503

Providence Regional Cancer System-Lacey, Lacey

98508

Anchorage Associates in Radiation Medicine, Anchorage

98520

Providence Regional Cancer System-Aberdeen, Aberdeen

98531

Providence Regional Cancer System-Centralia, Centralia

98632

PeaceHealth Saint John Medical Center, Longview

98664

PeaceHealth Southwest Medical Center, Vancouver

99362

Providence Saint Mary Regional Cancer Center, Walla Walla

99508

Alaska Breast Care and Surgery LLC, Anchorage

Alaska Oncology and Hematology LLC, Anchorage

Alaska Women's Cancer Care, Anchorage

Anchorage Oncology Centre, Anchorage

Katmai Oncology Group, Anchorage

Providence Alaska Medical Center, Anchorage

50266-7700

Methodist West Hospital, West Des Moines

04401

Eastern Maine Medical Center, Bangor

04412

Lafayette Family Cancer Center-EMMC, Brewer

02114

Massachusetts General Hospital Cancer Center, Boston

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH