Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

January 13, 2023

Study Completion Date

September 11, 2026

Conditions
GliosarcomaMGMT-Unmethylated Glioblastoma
Interventions
PROCEDURE

Contrast-enhanced Magnetic Resonance Imaging

Undergo contrast-enhanced brain MRI

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

DEVICE

NovoTTF-100A Device

Wear Optune device

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Temozolomide

Given PO

Trial Locations (285)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

NYP/Weill Cornell Medical Center, New York

11795

Good Samaritan University Hospital, West Islip

13210

State University of New York Upstate Medical University, Syracuse

14642

University of Rochester, Rochester

15090

Wexford Health and Wellness Pavilion, Wexford

15146

Forbes Hospital, Monroeville

15212

Allegheny General Hospital, Pittsburgh

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

UPMC-Shadyside Hospital, Pittsburgh

17601

Lancaster General Ann B Barshinger Cancer Institute, Lancaster

17602

Lancaster General Hospital, Lancaster

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

19008

Crozer-Keystone Regional Cancer Center at Broomall, Broomall

19107

Thomas Jefferson University Hospital, Philadelphia

19317

Christiana Care Health System-Concord Health Center, Chadds Ford

19611

Reading Hospital, West Reading

19713

Delaware Clinical and Laboratory Physicians PA, Newark

Helen F Graham Cancer Center, Newark

Medical Oncology Hematology Consultants PA, Newark

19718

Christiana Care Health System-Christiana Hospital, Newark

19958

Beebe Medical Center, Lewes

19967

Beebe South Coastal Health Campus, Millville

19971

Beebe Health Campus, Rehoboth Beach

21014

UM Upper Chesapeake Medical Center, Bel Air

21044

Central Maryland Radiation Oncology in Howard County, Columbia

21061

UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

22031

Inova Schar Cancer Institute, Fairfax

23298

VCU Massey Comprehensive Cancer Center, Richmond

23970

VCU Community Memorial Health Center, South Hill

26003

Wheeling Hospital/Schiffler Cancer Center, Wheeling

28025

Atrium Health Cabarrus/LCI-Concord, Concord

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28210

Atrium Health Pineville/LCI-Pineville, Charlotte

29730

Rock Hill Radiation Therapy Center, Rock Hill

30912

Augusta University Medical Center, Augusta

31404

Memorial Health University Medical Center, Savannah

31405

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah

31792

Lewis Hall Singletary Oncology Center, Thomasville

32207

Baptist MD Anderson Cancer Center, Jacksonville

32803

AdventHealth Orlando, Orlando

35233

University of Alabama at Birmingham Cancer Center, Birmingham

38017

Baptist Memorial Hospital and Cancer Center-Collierville, Collierville

38120

Baptist Memorial Hospital and Cancer Center-Memphis, Memphis

38671

Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven

39216

University of Mississippi Medical Center, Jackson

40536

University of Kentucky/Markey Cancer Center, Lexington

43016

Dublin Methodist Hospital, Dublin

43214

Riverside Methodist Hospital, Columbus

44106

Case Western Reserve University, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44304

Summa Health System - Akron Campus, Akron

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

IU Health Methodist Hospital, Indianapolis

48073

Corewell Health William Beaumont University Hospital, Royal Oak

48085

Corewell Health Beaumont Troy Hospital, Troy

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

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

48124

Corewell Health Dearborn Hospital, Dearborn

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

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

MyMichigan Medical Center Saginaw, Saginaw

48604

Oncology Hematology Associates of Saginaw Valley PC, Saginaw

48661

Saint Mary's Oncology/Hematology Associates of West Branch, West Branch

48764

MyMichigan Medical Center Tawas, Tawas City

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49048

Beacon Kalamazoo, Kalamazoo

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

49519

University of Michigan Health - West, Wyoming

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

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

51503

Heartland Oncology and Hematology LLP, Council Bluffs

Methodist Jennie Edmundson Hospital, Council Bluffs

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53022

Aurora Health Care Germantown Health Center, Germantown

53024

Aurora Cancer Care-Grafton, Grafton

53038

University of Wisconsin Carbone Cancer Center - Johnson Creek, Johnson Creek

53066

Aurora Medical Center in Summit, Summit

53081

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan

53105

Aurora Cancer Care-Southern Lakes VLCC, Burlington

53142

Aurora Cancer Care-Kenosha South, Kenosha

53209

Aurora Cancer Care-Milwaukee, Milwaukee

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

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

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

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

54548

Marshfield Medical Center - Minocqua, Minocqua

54904

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh

55082

Lakeview Hospital, Stillwater

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

55337

Fairview Ridges Hospital, Burnsville

Minnesota Oncology - Burnsville, Burnsville

55369

Fairview Clinics and Surgery Center Maple Grove, Maple Grove

55415

Hennepin County Medical Center, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55454

Health Partners Inc, Minneapolis

56601

Sanford Joe Lueken Cancer Center, Bemidji

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

57105

Avera Cancer Institute, Sioux Falls

57501

Avera Cancer Institute at Pierre, Pierre

58122

Sanford Broadway Medical Center, Fargo

Sanford Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

59101

Billings Clinic Cancer Center, Billings

59405

Benefis Sletten Cancer Institute, Great Falls

59701

Saint James Community Hospital and Cancer Treatment Center, Butte

59715

Bozeman Health Deaconess Hospital, Bozeman

59901

Logan Health Medical Center, Kalispell

60026

NorthShore University HealthSystem-Glenbrook Hospital, Glenview

60035

NorthShore University HealthSystem-Highland Park Hospital, Highland Park

60068

Advocate Lutheran General Hospital, Park Ridge

60115

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60126

Elmhurst Memorial Hospital, Elmhurst

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60540

Edward Hospital/Cancer Center, Naperville

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Northwestern University, Chicago

60612

University of Illinois, Chicago

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

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

61571

Illinois CancerCare - Washington, Washington

61615

Illinois CancerCare-Peoria, 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

63703

Saint Francis Medical Center, Cape Girardeau

68114

Nebraska Methodist Hospital, Omaha

68118

Nebraska Medicine-Village Pointe, Omaha

68123

Nebraska Medicine-Bellevue, Bellevue

68198

University of Nebraska Medical Center, Omaha

68516

Cancer Partners of Nebraska, Lincoln

70112

Tulane University School of Medicine, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73505

Cancer Centers of Southwest Oklahoma Research, Lawton

77030

Memorial Hermann Texas Medical Center, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

80122

AdventHealth Littleton, Littleton

80138

AdventHealth Parker, Parker

80210

AdventHealth Porter, Denver

80907

Penrose-Saint Francis Healthcare, Colorado Springs

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

Saint Luke's Cancer Institute - Meridian, Meridian

83687

Saint Alphonsus Cancer Care Center-Nampa, Nampa

Saint Luke's Cancer Institute - Nampa, Nampa

83712

Saint Luke's Cancer Institute - Boise, Boise

84003

American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork

84065

Riverton Hospital, Riverton

84107

Intermountain Medical Center, Murray

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84321

Logan Regional Hospital, Logan

84403

McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center, Provo

84720

Sandra L Maxwell Cancer Center, Cedar City

84770

Saint George Regional Medical Center, St. George

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90505

Torrance Memorial Physician Network - Cancer Care, Torrance

90509

Torrance Memorial Medical Center, Torrance

91761

Kaiser Permanente-Ontario, Ontario

92093

UC San Diego Moores Cancer Center, La Jolla

92354

Loma Linda University Medical Center, Loma Linda

92806

Kaiser Permanente-Anaheim, Anaheim

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

94520

John Muir Medical Center-Concord, Concord

94598

John Muir Medical Center-Walnut Creek, Walnut Creek

95602

Sutter Auburn Faith Hospital, Auburn

95603

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn

95661

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

Sutter Roseville Medical Center, Roseville

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96701

Hawaii Cancer Care - Westridge, ‘Aiea

Pali Momi Medical Center, ‘Aiea

Queen's Cancer Center - Pearlridge, ‘Aiea

The Cancer Center of Hawaii-Pali Momi, ‘Aiea

96734

Castle Medical Center, Kailua

96766

Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue

96813

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu

Island Urology, Honolulu

Queen's Cancer Cenrer - POB I, Honolulu

Queen's Medical Center, Honolulu

Straub Clinic and Hospital, Honolulu

University of Hawaii Cancer Center, Honolulu

96817

Hawaii Cancer Care Inc-Liliha, Honolulu

Queen's Cancer Center - Kuakini, Honolulu

The Cancer Center of Hawaii-Liliha, Honolulu

96826

Kapiolani Medical Center for Women and Children, Honolulu

97015

Clackamas Radiation Oncology Center, Clackamas

Providence Cancer Institute Clackamas Clinic, Clackamas

97030

Legacy Mount Hood Medical Center, Gresham

97062

Legacy Meridian Park Hospital, Tualatin

97132

Providence Newberg Medical Center, Newberg

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

97227

Kaiser Permanente Northwest, Portland

98101

Virginia Mason Medical Center, Seattle

98684

Legacy Cancer Institute Medical Oncology and Day Treatment, Vancouver

98686

Legacy Salmon Creek Hospital, Vancouver

06102

Hartford Hospital, Hartford

06050

The Hospital of Central Connecticut, New Britain

04401

Eastern Maine Medical Center, Bangor

04530

MaineHealth Coastal Cancer Treatment Center, Bath

04915

MaineHealth Waldo Hospital, Belfast

04412

Lafayette Family Cancer Center-EMMC, Brewer

04102

MaineHealth Maine Medical Center - Portland, Portland

04856

Penobscot Bay Medical Center, Rockport

04073

MaineHealth Cancer Care Center of York County, Sanford

04074

Maine Medical Partners Neurology, Scarborough

MaineHealth Maine Medical Center- Scarborough, Scarborough

04106

MaineHealth Cancer Care and IV Therapy - South Portland, South Portland

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

07039

Saint Barnabas Medical Center, Livingston

07960

Morristown Medical Center, Morristown

07753

Jersey Shore Medical Center, Neptune City

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

08534

Capital Health Medical Center-Hopewell, Pennington

07902

Overlook Hospital, Summit

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05401

University of Vermont Medical Center, Burlington

05405

University of Vermont and State Agricultural College, Burlington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NRG Oncology

OTHER

lead

National Cancer Institute (NCI)

NIH