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

Study Purpose

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy plus 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. Immunotherapy with monoclonal antibodies, 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. Giving radiation therapy with ipilimumab and nivolumab lengthen the time without brain tumor from returning or growing and extend patients life compared to usual treatment of radiation therapy and chemotherapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 NRG Oncology biospecimen bank 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 and stratification 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
  • - Contrast-enhanced brain MRI within 72 hours 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 72 hours 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 biopsy or 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.
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: - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04396860
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andrew B Lassman
Principal Investigator Affiliation NRG Oncology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIHOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gliosarcoma, MGMT-Unmethylated Glioblastoma
Additional Details

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 over 30 fractions for 5 days per week (Monday-Friday) and 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 over 30 fractions for 5 days per week (Monday-Friday) for 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.

Arms & Interventions

Arms

Active Comparator: Arm I (radiation therapy, temozolomide)

Patients undergo radiation therapy over 30 fractions for 5 days per week (Monday-Friday) and 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.

Experimental: Arm II (radiation therapy, ipilimumab, nivolumab)

Patients undergo radiation therapy over 30 fractions for 5 days per week (Monday-Friday) for 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC San Diego Moores Cancer Center, La Jolla, California

Status

Recruiting

Address

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Site Contact

Site Public Contact

cancercto@ucsd.edu

858-822-5354

Los Angeles, California

Status

Recruiting

Address

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Site Contact

Site Public Contact

clinical.trials@kp.org

800-398-3996

Orange, California

Status

Recruiting

Address

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

Site Contact

Site Public Contact

ucstudy@uci.edu

877-827-8839

Illinois CancerCare-Bloomington, Bloomington, Illinois

Status

Recruiting

Address

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Canton, Canton, Illinois

Status

Recruiting

Address

Illinois CancerCare-Canton

Canton, Illinois, 61520

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Carthage, Carthage, Illinois

Status

Recruiting

Address

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

DeKalb, Illinois

Status

Recruiting

Address

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

Site Contact

Site Public Contact

Donald.Smith3@nm.org

630-352-5360

Illinois CancerCare-Eureka, Eureka, Illinois

Status

Recruiting

Address

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Evanston, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201

Site Contact

Site Public Contact

847-570-2109

Illinois CancerCare-Galesburg, Galesburg, Illinois

Status

Recruiting

Address

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Western Illinois Cancer Treatment Center, Galesburg, Illinois

Status

Recruiting

Address

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

Site Contact

Site Public Contact

309-344-2831

Geneva, Illinois

Status

Recruiting

Address

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

Site Contact

Site Public Contact

Donald.Smith3@nm.org

630-352-5360

Glenview, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026

Site Contact

Site Public Contact

847-570-2109

Highland Park, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035

Site Contact

Site Public Contact

847-570-2109

Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois

Status

Recruiting

Address

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Macomb, Macomb, Illinois

Status

Recruiting

Address

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois

Status

Recruiting

Address

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Pekin, Pekin, Illinois

Status

Recruiting

Address

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Peoria, Peoria, Illinois

Status

Recruiting

Address

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Methodist Medical Center of Illinois, Peoria, Illinois

Status

Recruiting

Address

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

OSF Saint Francis Medical Center, Peoria, Illinois

Status

Recruiting

Address

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Peru, Peru, Illinois

Status

Recruiting

Address

Illinois CancerCare-Peru

Peru, Illinois, 61354

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Illinois CancerCare-Princeton, Princeton, Illinois

Status

Recruiting

Address

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

Site Contact

Site Public Contact

andersonj@illinoiscancercare.com

309-243-3605

Warrenville, Illinois

Status

Recruiting

Address

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

Site Contact

Site Public Contact

Donald.Smith3@nm.org

630-352-5360

Mary Greeley Medical Center, Ames, Iowa

Status

Recruiting

Address

Mary Greeley Medical Center

Ames, Iowa, 50010

Site Contact

Site Public Contact

515-956-4132

McFarland Clinic PC - Ames, Ames, Iowa

Status

Recruiting

Address

McFarland Clinic PC - Ames

Ames, Iowa, 50010

Site Contact

Site Public Contact

ksoder@mcfarlandclinic.com

515-239-4734

Iowa Methodist Medical Center, Des Moines, Iowa

Status

Recruiting

Address

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

515-241-6727

Des Moines, Iowa

Status

Recruiting

Address

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

515-282-2921

Broadlawns Medical Center, Des Moines, Iowa

Status

Recruiting

Address

Broadlawns Medical Center

Des Moines, Iowa, 50314

Site Contact

Site Public Contact

515-282-2200

Tulane University Health Sciences Center, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112

Site Contact

Site Public Contact

504-988-6121

Ochsner Medical Center Jefferson, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Site Contact

Site Public Contact

Gregory.Johnstone@ochsner.org

504-703-8712

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

Site Contact

Site Public Contact

800-888-8823

Columbia, Maryland

Status

Recruiting

Address

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044

Site Contact

Site Public Contact

443-546-1300

Glen Burnie, Maryland

Status

Recruiting

Address

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

Site Contact

Site Public Contact

410-553-8100

Saint Joseph Mercy Hospital, Ann Arbor, Michigan

Status

Recruiting

Address

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Saint Joseph Mercy Brighton, Brighton, Michigan

Status

Recruiting

Address

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Saint Joseph Mercy Canton, Canton, Michigan

Status

Recruiting

Address

Saint Joseph Mercy Canton

Canton, Michigan, 48188

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Saint Joseph Mercy Chelsea, Chelsea, Michigan

Status

Recruiting

Address

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Genesys Hurley Cancer Institute, Flint, Michigan

Status

Recruiting

Address

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Hurley Medical Center, Flint, Michigan

Status

Recruiting

Address

Hurley Medical Center

Flint, Michigan, 48503

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Bronson Methodist Hospital, Kalamazoo, Michigan

Status

Recruiting

Address

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

West Michigan Cancer Center, Kalamazoo, Michigan

Status

Recruiting

Address

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Borgess Medical Center, Kalamazoo, Michigan

Status

Recruiting

Address

Borgess Medical Center

Kalamazoo, Michigan, 49048

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Saint Mary Mercy Hospital, Livonia, Michigan

Status

Recruiting

Address

Saint Mary Mercy Hospital

Livonia, Michigan, 48154

Site Contact

Site Public Contact

stephanie.couch@stjoeshealth.org

734-712-3671

Sanford Joe Lueken Cancer Center, Bemidji, Minnesota

Status

Recruiting

Address

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

Fairview Southdale Hospital, Edina, Minnesota

Status

Recruiting

Address

Fairview Southdale Hospital

Edina, Minnesota, 55435

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Health Partners Inc, Minneapolis, Minnesota

Status

Recruiting

Address

Health Partners Inc

Minneapolis, Minnesota, 55454

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Regions Hospital, Saint Paul, Minnesota

Status

Recruiting

Address

Regions Hospital

Saint Paul, Minnesota, 55101

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Lakeview Hospital, Stillwater, Minnesota

Status

Recruiting

Address

Lakeview Hospital

Stillwater, Minnesota, 55082

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Saint Francis Medical Center, Cape Girardeau, Missouri

Status

Recruiting

Address

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Site Contact

Site Public Contact

sfmc@sfmc.net

573-334-2230

Nebraska Methodist Hospital, Omaha, Nebraska

Status

Recruiting

Address

Nebraska Methodist Hospital

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

402-354-5144

Overlook Hospital, Summit, New Jersey

Status

Recruiting

Address

Overlook Hospital

Summit, New Jersey, 07902

Site Contact

Site Public Contact

908-522-2043

New York, New York

Status

Recruiting

Address

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032

Site Contact

Site Public Contact

nr2616@cumc.columbia.edu

212-305-6361

Sanford Bismarck Medical Center, Bismarck, North Dakota

Status

Recruiting

Address

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

Sanford Broadway Medical Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Sanford Roger Maris Cancer Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Site Contact

Site Public Contact

ou-clinical-trials@ouhsc.edu

405-271-8777

Legacy Mount Hood Medical Center, Gresham, Oregon

Status

Recruiting

Address

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030

Site Contact

Site Public Contact

503-413-2150

Portland, Oregon

Status

Recruiting

Address

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210

Site Contact

Site Public Contact

cancer@lhs.org

800-220-4937

Legacy Meridian Park Hospital, Tualatin, Oregon

Status

Recruiting

Address

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062

Site Contact

Site Public Contact

503-413-1742

Avera Cancer Institute at Pierre, Pierre, South Dakota

Status

Recruiting

Address

Avera Cancer Institute at Pierre

Pierre, South Dakota, 57501

Site Contact

Site Public Contact

OncRegulatory@avera.org

605-322-3095

Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota

Status

Recruiting

Address

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

Site Contact

Site Public Contact

OncologyClinicTrialsSF@sanfordhealth.org

605-312-3320

Avera Cancer Institute, Sioux Falls, South Dakota

Status

Recruiting

Address

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Site Contact

Site Public Contact

OncRegulatory@avera.org

605-322-3095

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota

Status

Recruiting

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

Site Contact

Site Public Contact

OncologyClinicalTrialsSF@SanfordHealth.org

605-312-3320

Memorial Hermann Texas Medical Center, Houston, Texas

Status

Recruiting

Address

Memorial Hermann Texas Medical Center

Houston, Texas, 77030

Site Contact

Site Public Contact

713-792-3245

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Site Contact

Site Public Contact

phoresearchoffice@uthscsa.edu

210-450-3800

Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

Site Contact

Site Public Contact

cancerinfo@hci.utah.edu

888-424-2100

Vancouver, Washington

Status

Recruiting

Address

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, 98684

Site Contact

Site Public Contact

oncologyresearch@lhs.org

Legacy Salmon Creek Hospital, Vancouver, Washington

Status

Recruiting

Address

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686

Site Contact

Site Public Contact

503-413-2150

Cancer Center of Western Wisconsin, New Richmond, Wisconsin

Status

Recruiting

Address

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

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