Purpose

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, 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. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION: - No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered) - Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin & eosin (H&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 23. If tissue cannot be received by postoperative calendar day 23, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 6 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be conveyed to NRG Oncology within 10 business days of receipt of tissue. Note: In the event of an additional tumor resection(s), tissue must be received within 23 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis - Contrast-enhanced brain MRI within 3 days after surgery - Magnetic resonance imaging (MRI) with Axial T2 weighted FLAIR {preferred} or T2 turbo spin echo (TSE)/fast spin echo (FSE) and 3-dimensional (3D) contrast-enhanced T1 sequences are required - 3D pre contrast-enhanced T1 sequences are strongly suggested - Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use an adequate method of contraception hormonal or barrier method of birth control; or abstinence during and after treatment - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry - PRIOR TO STEP 2 REGISTRATION: - Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review - MGMT promoter without methylation confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or methylated MGMT promoter are excluded - IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at step 2.) - History/physical examination within 28 days prior to step 2 registration - Karnofsky Performance Status (KPS) >= 70 within 28 days prior to step 2 registration - Neurologic function assessment within 28 days prior to step 2 registration - Hemoglobin >= 10 g/dl (Note: the use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable) (within 7 days prior to Step 2 registration) - Leukocytes >= 2,000/mm^3 (within 7 days prior to Step 2 registration) - Absolute neutrophil count >= 1,500/mm^3 (within 7 days prior to Step 2 registration) - Platelets >= 100,000/mm^3 (within 7 days prior to Step 2 registration) - Total bilirubin =< 1.5 x institutional/lab upper limit of normal (ULN) (within 7 days prior to Step 2 registration) - Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x ULN (within 7 days prior to Step 2 registration) - Alanine transferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (within 7 days prior to Step 2 registration) - Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50mL/min (if using the Cockcroft-Gault formula) (within 7 days prior to Step 2 registration) - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - For women of childbearing potential (WOCBP), negative serum or urine pregnancy test within 7 days prior to step 2 registration. Note that it may need to be repeated if not also within 3 days prior to treatment start - Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes

Exclusion Criteria

  • Prior therapy for tumor except for resection. For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is prior Laser interstitial thermal therapy (LITT), Gliadel wafer, radiotherapy, radiosurgery, gamma knife, cyber knife, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery; - Note that 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent - Current or planned treatment with any other investigational agents for the study cancer - Definitive clinical or radiologic evidence of metastatic disease outside the brain - Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years - Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields - Pregnancy and nursing females due to the potential teratogenic effects and potential risk for adverse events in nursing infants - History of severe hypersensitivity reaction to any monoclonal antibody - History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab, nivolumab, or temozolomide - On any dose of any systemically administered (oral, rectal, intravenous) corticosteroid within 3 days prior to step 2 registration. Inhaled, topical, and ocular corticosteroids are allowed without limitation but must be recorded. Note that treatment with systemically administered corticosteroid after initiating study treatment is allowed as needed - Patients with known immune impairment who may be unable to respond to anti-CTLA 4 antibody - History of interstitial lung disease including but not limited to sarcoidosis or pneumonitis - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, defined as New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, are excluded, as are patients on active immunosuppressive therapy. These include but are not limited to: patients with a history of immune-related neurologic disease, central nervous system (CNS) or motor neuropathy, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as autoimmune vasculitis [e.g., Wegener's Granulomatosis]), systemic lupus erythematosus (SLE), connective tissue diseases (e.g., systemic progressive sclerosis), scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome, Hashimoto's thyroiditis, autoimmune hepatitis are excluded because of the risk of recurrence or exacerbation of disease - Exceptions: patients with a history of the following conditions are not excluded, unless receiving active immunosuppressive therapy: - Vitiligo - Endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids - Rheumatoid arthritis and other arthropathies - Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA) - Anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible - Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation are also excluded - Current or planned therapy with warfarin

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (radiation therapy, temozolomide)
Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity.
  • Device: NovoTTF-100A Device
    Wear Optune device
    Other names:
    • NovoTTF-100A
    • NovoTTF-100A System
    • NovoTTFields
    • NovoTumor Treatment Fields
    • Optune
    • Optune Device
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
  • Drug: Temozolomide
    Given PO
    Other names:
    • CCRG-81045
    • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
    • M & B 39831
    • M and B 39831
    • Methazolastone
    • RP-46161
    • SCH 52365
    • Temcad
    • Temodal
    • Temodar
    • Temomedac
    • TMZ
Experimental
Arm II (radiation therapy, ipilimumab, nivolumab)
Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression.
  • Biological: Ipilimumab
    Given IV
    Other names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS-734016
    • Ipilimumab Biosimilar CS1002
    • MDX-010
    • MDX-CTLA4
    • Yervoy
  • Biological: Nivolumab
    Given IV
    Other names:
    • BMS-936558
    • CMAB819
    • MDX-1106
    • NIVO
    • Nivolumab Biosimilar CMAB819
    • ONO-4538
    • Opdivo
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Anaheim
Anaheim, California 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

John Muir Medical Center-Concord Campus
Concord, California 94520
Contact:
Site Public Contact
925-674-2580

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Loma Linda University Medical Center
Loma Linda, California 92354
Contact:
Site Public Contact
909-558-4050

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
Contact:
Site Public Contact
925-941-4246

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

Porter Adventist Hospital
Denver, Colorado 80210
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

Littleton Adventist Hospital
Littleton, Colorado 80122
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

Parker Adventist Hospital
Parker, Colorado 80138
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

Hartford Hospital
Hartford, Connecticut 06102
Contact:
Site Public Contact
860-545-5363

The Hospital of Central Connecticut
New Britain, Connecticut 06050
Contact:
Site Public Contact
860-224-5660

Beebe South Coastal Health Campus
Frankford, Delaware 19945
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

Beebe Health Campus
Rehoboth Beach, Delaware 19971
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7468

AdventHealth Orlando
Orlando, Florida 32803
Contact:
Site Public Contact
407-303-2090
FH.Cancer.Research@flhosp.org

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Memorial Health University Medical Center
Savannah, Georgia 31404
Contact:
Site Public Contact
912-350-7887
Lorraine.OHara@hcahealthcare.com

Lewis Hall Singletary Oncology Center
Thomasville, Georgia 31792
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Hawaii Cancer Care - Savio
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-539-2273
info@hawaiicancercare.com

The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-678-9000

Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-524-6115
i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-532-0315

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333

Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-531-8521

The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-547-6881

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Contact:
Site Public Contact
808-983-6090

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Illinois
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046

Carle on Vermilion
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Elmhurst Memorial Hospital
Elmhurst, Illinois 60126
Contact:
Site Public Contact
630-758-5460
Jrohde@emhc.org

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Edward Hospital/Cancer Center
Naperville, Illinois 60540
Contact:
Site Public Contact
630-646-6075

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

IU Health Methodist Hospital
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
515-643-2196
cancerresearch@mercydesmoines.org

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
515-643-2196
cancerresearch@mercydesmoines.org

Jennie Edmundson Memorial Hospital
Council Bluffs, Iowa 51502
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Heartland Oncology and Hematology LLP
Council Bluffs, Iowa 51503
Contact:
Site Public Contact
712-322-4136

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
515-643-2196
cancerresearch@mercydesmoines.org

Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-643-2196
cancerresearch@mercydesmoines.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-643-2196
cancerresearch@mercydesmoines.org

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
515-643-2196
cancerresearch@mercydesmoines.org

Tulane University Health Sciences Center
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-988-6121

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-842-8084
Elisemarie.curry@ochsner.org

Eastern Maine Medical Center
Bangor, Maine 04401
Contact:
Site Public Contact
207-973-4274

MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Waldo County General Hospital
Belfast, Maine 04915
Contact:
Site Public Contact
207-338-2500

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565

Penobscot Bay Medical Center
Rockport, Maine 04856
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
Contact:
Site Public Contact
207-459-1600

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

Maine Medical Partners Neurology
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

Maine Medical Partners - South Portland
South Portland, Maine 04106
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010

Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
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734-712-3671
stephanie.couch@stjoeshealth.org

Beaumont Hospital - Dearborn
Dearborn, Michigan 48124
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248-551-7695

Genesys Hurley Cancer Institute
Flint, Michigan 48503
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734-712-3671
stephanie.couch@stjoeshealth.org

Hurley Medical Center
Flint, Michigan 48503
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734-712-3671
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Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
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616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
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616-391-1230
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West Michigan Cancer Center
Kalamazoo, Michigan 49007
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616-391-1230
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Saint Mary Mercy Hospital
Livonia, Michigan 48154
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734-712-3671
stephanie.couch@stjoeshealth.org

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
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734-712-3671
stephanie.couch@stjoeshealth.org

William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
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248-551-7695

Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
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734-712-3671
stephanie.couch@stjoeshealth.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
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Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
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734-712-3671
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William Beaumont Hospital - Troy
Troy, Michigan 48085
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248-551-7695

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
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734-712-3671
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Metro Health Hospital
Wyoming, Michigan 49519
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616-391-1230
crcwm-regulatory@crcwm.org

IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
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734-712-3671
stephanie.couch@stjoeshealth.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
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218-333-5000
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Mercy Hospital
Coon Rapids, Minnesota 55433
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952-993-1517
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Fairview Southdale Hospital
Edina, Minnesota 55435
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952-993-1517
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Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
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952-993-1517
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
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952-993-1517
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Regions Hospital
Saint Paul, Minnesota 55101
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952-993-1517
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United Hospital
Saint Paul, Minnesota 55102
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952-993-1517
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University of Mississippi Medical Center
Jackson, Mississippi 39216
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601-815-6700

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
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573-334-2230
sfmc@sfmc.net

Billings Clinic Cancer Center
Billings, Montana 59101
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800-996-2663
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Saint James Community Hospital and Cancer Treatment Center
Butte, Montana 59701
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406-723-2621

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
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406-969-6060
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Kalispell Regional Medical Center
Kalispell, Montana 59901
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406-969-6060
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Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
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402-559-6941
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Cancer Partners of Nebraska - Pine Lake
Lincoln, Nebraska 68516
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402-327-7363
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Southeast Nebraska Cancer Center - 68th Street Place
Lincoln, Nebraska 68516
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402-327-7363
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Nebraska Methodist Hospital
Omaha, Nebraska 68114
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402-354-5144

Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
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402-559-5600

University of Nebraska Medical Center
Omaha, Nebraska 68198
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402-559-6941
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Hackensack University Medical Center
Hackensack, New Jersey 07601
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201-996-2879

Capital Health Medical Center-Hopewell
Pennington, New Jersey 08534
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609-394-4130
clinicaltrials@capitalhealth.org

Overlook Hospital
Summit, New Jersey 07902
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908-522-2043

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
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CancerTrials@nyulangone.org

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
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212-305-6361
nr2616@cumc.columbia.edu

NYP/Weill Cornell Medical Center
New York, New York 10065
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212-746-1848

University of Rochester
Rochester, New York 14642
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585-275-5830

State University of New York Upstate Medical University
Syracuse, New York 13210
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315-464-5476

Good Samaritan Hospital Medical Center
West Islip, New York 11795
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631-376-4444

Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
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800-804-9376

Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina 28210
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980-442-2000

Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
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800-804-9376

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
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701-323-5760
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Sanford Broadway Medical Center
Fargo, North Dakota 58122
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701-323-5760
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Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
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701-234-6161
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Summa Health System - Akron Campus
Akron, Ohio 44304
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330-375-4221
cancerresearch@summahealth.org

Case Western Reserve University
Cleveland, Ohio 44106
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800-641-2422
CTUReferral@UHhospitals.org

Riverside Methodist Hospital
Columbus, Ohio 43214
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614-566-4475
sheree@columbusccop.org

Dublin Methodist Hospital
Dublin, Ohio 43016
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800-752-9119
sheree@columbusccop.org

Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
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503-215-2614
CanRsrchStudies@providence.org

Legacy Mount Hood Medical Center
Gresham, Oregon 97030
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503-413-2150

Providence Newberg Medical Center
Newberg, Oregon 97132
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503-215-2614
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Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
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800-220-4937
cancer@lhs.org

Providence Portland Medical Center
Portland, Oregon 97213
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503-215-2614
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Providence Saint Vincent Medical Center
Portland, Oregon 97225
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503-215-2614
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Kaiser Permanente Northwest
Portland, Oregon 97227
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503-335-2400
information@kpchr.org

Legacy Meridian Park Hospital
Tualatin, Oregon 97062
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503-413-1742

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
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stephanie.couch@stjoeshealth.org

Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania 19008
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610-284-8237
Jolene.garney@crozer.org

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
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302-623-4450
mhayden@christianacare.org

Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania 17601
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717-544-0511

Lancaster General Hospital
Lancaster, Pennsylvania 17602
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717-544-5511

Forbes Hospital
Monroeville, Pennsylvania 15146
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412-858-7746

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
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215-600-9151
ONCTrialNow@jefferson.edu

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
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877-284-2000

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
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412-647-8073

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
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Dawnmarie.DeFazio@ahn.org

Rock Hill Radiation Therapy Center
Rock Hill, South Carolina 29730
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800-804-9376

Avera Cancer Institute at Pierre
Pierre, South Dakota 57501
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605-322-3095
OncRegulatory@avera.org

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
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605-312-3320
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Avera Cancer Institute
Sioux Falls, South Dakota 57105
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605-322-3095
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
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605-312-3320
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Memorial Hermann Texas Medical Center
Houston, Texas 77030
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713-792-3245

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
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210-450-3800
phoresearchoffice@uthscsa.edu

Dixie Medical Center Regional Cancer Center
Saint George, Utah 84770
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435-688-4167
officeofresearch@imail.org

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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888-424-2100
cancerinfo@hci.utah.edu

Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
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802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
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802-656-4101
rpo@uvm.edu

Inova Schar Cancer Institute
Fairfax, Virginia 22031
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703-720-5210
Stephanie.VanBebber@inova.org

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
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CTOclinops@vcu.edu

VCU Community Memorial Health Center
South Hill, Virginia 23970
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434-774-2442
sherman.baker@vcuhealth.org

Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
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oncologyresearch@lhs.org

Legacy Salmon Creek Hospital
Vancouver, Washington 98686
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503-413-2150

Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia 26003
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304-243-6442

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
Contact:
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952-993-1517
mmcorc@healthpartners.com

More Details

NCT ID
NCT04396860
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES: I. To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs progression-free survival (PFS) versus adding temozolomide to radiotherapy in patients with newly diagnosed glioblastoma (GBM) without MGMT promoter methylation. (Phase II) II. To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs overall survival (OS) versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation. (Phase III) SECONDARY OBJECTIVES: I. To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs PFS versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation for the phase III part of the study. II. To determine if adding ipilimumab and nivolumab to radiotherapy significantly increases the 2-year overall survival (OS) rate versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation. III. To evaluate the safety of adding ipilimumab and nivolumab to radiotherapy via comparative frequency between arms of specific adverse events of interest and frequency summaries for all adverse event types. IV. To evaluate the effect of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on patient reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM without MGMT promoter methylation. V. To evaluate the effect of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on selected Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in patients with newly diagnosed GBM without MGMT promoter methylation. VI. To evaluate the impact of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on neurocognitive function (NCF) in patients with newly diagnosed GBM without MGMT promoter methylation. EXPLORATORY OBJECTIVES: I. To explore biomarkers in pre-treatment archival tumor tissue that may predict efficacy of ipilimumab and nivolumab as measured by OS, PFS, and 2-year OS rate, such as but not limited to: Ia. PDL1 expression Ib. Mutational burden II. To explore (in the two treatment separately) whether the MGMT protein expression correlates with clinical outcomes including OS, PFS, and 2-year OS rate. III. To evaluate if MGMT protein expression may be predictive of differential treatment effects between the two treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide orally (PO) daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. ARM 2: Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab intravenously (IV) over 90 minutes once every 4 weeks (Q4W) for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. After completion of study treatment, patients are followed up every 3 months for year 1, then every 4 months for year 2, and then every 6 months thereafter.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.