AzTrials
AzTrials

GliosarcomaPhase 2/3NCT04396860

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

A Phase 2/3 study testing Contrast-enhanced Magnetic Resonance Imaging, Ipilimumab and Nivolumab in people with Gliosarcoma and MGMT-Unmethylated Glioblastoma, run by National Cancer Institute (NCI) at 285 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gliosarcoma, MGMT-Unmethylated Glioblastoma
What is being tested?
Contrast-enhanced Magnetic Resonance Imaging, Ipilimumab and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
285 sitesUnited States
Study dates
1 Sep 2020to 23 Dec 2025
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (partial or complete) is required; a limited biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
  • Note: The central pathology review and central MGMT results determine eligibility. Therefore, patients may be offered the opportunity to consent REGARDLESS of local pathology and MGMT results, and consent can occur BEFORE local pathology interpretation is finalized and BEFORE local MGMT testing is conducted
  • Contrast-enhanced brain MRI within 3 days after surgery
  • 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
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  • 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
  • Note: diagnoses of "Molecular glioblastoma" per the Consortium to Inform Molecular and Practical Approaches to Central Nervous System (CNS) Tumor Taxonomy (c-IMPACT-NOW) criteria or "CNS grade 4" per the World Health Organization (WHO) 2021 criteria are NOT relevant
  • 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.
  • Note: central pathology review and central MGMT results determine eligibility; local pathology or MGMT results cannot be used for eligibility/randomization
  • Note: patients with methylated MGMT may be considered for enrollment on NRG-BN011
  • 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.)
  • Note: this test is not being performed in real time as part of central review and will not be provided to sites from a centrally performed test
  • 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
  • Age >= 18 years
  • Hemoglobin >= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [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) >= 50 mL/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

Who cannot join

  • 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
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  • 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, 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
  • Type I diabetes
  • 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 locations and contacts

285 sites in 1 country.

285 sites in 1 country

United States285 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • MaineHealth Waldo Hospital

    Belfast, Maine, 04915

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

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

    Clive, Iowa, 50325

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • John Muir Medical Center-Concord

    Concord, California, 94520

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

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

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Island Urology

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Lancaster General Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

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

    New York, New York, 10032

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • AdventHealth Parker

    Parker, Colorado, 80138

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Avera Cancer Institute at Pierre

    Pierre, South Dakota, 57501

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Riverton Hospital

    Riverton, Utah, 84065

  • University of Rochester

    Rochester, New York, 14642

  • Rock Hill Radiation Therapy Center

    Rock Hill, South Carolina, 29730

  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

  • Penobscot Bay Medical Center

    Rockport, Maine, 04856

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

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

    Savannah, Georgia, 31405

  • Maine Medical Partners Neurology

    Scarborough, Maine, 04074

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • VCU Community Memorial Health Center

    South Hill, Virginia, 23970

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Saint George Regional Medical Center

    St. George, Utah, 84770

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Overlook Hospital

    Summit, New Jersey, 07902

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • Torrance Memorial Medical Center

    Torrance, California, 90509

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    Vancouver, Washington, 98684

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

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

    West Branch, Michigan, 48661

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Good Samaritan University Hospital

    West Islip, New York, 11795

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090

  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients With Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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 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.

  1. 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:

  1. 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. Patients also undergo contrast-enhanced brain magnetic resonance imaging (MRI) throughout the trial.

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. Patients also undergo contrast-enhanced brain MRI throughout the trial.

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.

Being tested
Contrast-enhanced Magnetic Resonance Imaging, Ipilimumab, Nivolumab, NovoTTF-100A Device, Quality-of-Life Assessment
Medical subject headings
Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery

    Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast

    Undergo contrast-enhanced brain MRI

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016

    Given IV

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • NovoTTF-100A DeviceDevice

    Also called NovoTTF-100A, NovoTTF-100A System, NovoTTF-100A system (Optune), NovoTTFields

    Wear Optune device

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

  • TemozolomideDrug

    Also called CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831

    Given PO

Study groups in NCT04396860
Study groupRoleWhat they receive
Arm I (radiation therapy, temozolomide)Active comparatorPatients 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. Patients also undergo contrast-enhanced brain MRI throughout the trial.
Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Device: NovoTTF-100A Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Drug: Temozolomide
Arm II (radiation therapy, ipilimumab, nivolumab)ExperimentalPatients 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. Patients also undergo contrast-enhanced brain MRI throughout the trial.
Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Biological: Ipilimumab; Biological: Nivolumab; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) (Phase II)

    Disease progression was confirmed by central review and defined using an adaptation of the Response Assessment in Neuro-Oncology criteria (Wen et al, J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15) with modification such that the first MRI performed following completion of radiotherapy is the baseline MRI for determination of radiographic disease. Progression-free survival time is defined as time from randomization to the date of first progression, death, or the last progression assessment with no documented progression (censored). Progression-free survival rates were estimated using the Kaplan-Meier method.

    Measured: From randomization to date of progression, death, or last known follow-up, whichever occurs first. Maximum follow-up time was 19.3 months.

  2. Overall Survival (OS) (Phase III)

    Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates were to be estimated by the Kaplan-Meier method.

    Measured: From randomization to date of death or last known follow-up. Maximum follow-up time was 19.3 months.

Secondary outcomes (6)

  1. PFS for the Entire Cohort (Phase II/III)

    Disease progression was confirmed by central review and defined using an adaptation of the Response Assessment in Neuro-Oncology criteria (Wen et al, J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15) with modification such that the first MRI performed following completion of radiotherapy is the baseline MRI for determination of radiographic disease. Progression-free survival time is defined as time from randomization to the date of first progression, death, or the last progression assessment with no documented progression (censored). Progression-free survival rates were estimated using the Kaplan-Meier method.

    Measured: From randomization to date of progression, death, or last known follow-up. Maximum follow-up time was 19.3 months.

  2. Overall Survival at 2 Years

    Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year survival rates were to be estimated by the Kaplan-Meier method.

    Measured: From randomization to two years

  3. Number of Participants by Highest Grade Adverse Event Reported

    Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From randomization to date of last known follow-up. Maximum follow-up time was 19.3 months.

  4. Change in MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) at Six Months (Patient Reported Outcomes)

    The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score is the average of the subscale items, given that a specified minimum numbers of items were completed.

    Measured: Up to 2 years

  5. Neurocognitive Function (NCF)

    Measured: Up to 2 years

  6. Selected Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items

    Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start1 Sep 2020
  3. Primary completion13 Jan 2023
  4. Study completion23 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396860
Sponsor's protocol ID
NCI-2020-03404
Other IDs
NCI-2020-03404, NRG-BN007, NRG-BN007, U10CA180868
Status last verified
Apr 2026
First submitted
20 May 2020
Last updated
22 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Lassman AB, Polley MC, Iwamoto FM, Sloan AE, Wang TJC, Aldape KD, Wefel JS, Gondi V, Gutierrez AN, Manasawala MH, Gilbert MR, Sulman EP, Wolchok JD, Green RM, Neil EC, Lukas RV, Goldlust SA, Snuderl M, Galbraith K, Dignam JJ, Won M, Mehta MP. Dual Immune Check Point Blockade in MGMT-Unmethylated Newly Diagnosed Glioblastoma: NRG Oncology BN007, a Randomized Phase II/III Clinical Trial. J Clin Oncol. 2025 Sep 20;43(27):3032-3040. doi: 10.1200/JCO-25-00618. Epub 2025 Aug 8.

    PubMed 40779733

  • Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

    PubMed 32691060

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Contrast-enhanced Magnetic Resonance Imaging, Ipilimumab and Nivolumab in people with Gliosarcoma and MGMT-Unmethylated Glioblastoma, run by National Cancer Institute (NCI) at 285 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 285 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (Phase II) (time frame: From randomization to date of progression, death, or last known follow-up, whichever occurs first. Maximum follow-up time was 19.3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396860, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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