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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

Trial Status: Active

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.

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

California

Anaheim
Kaiser Permanente-Anaheim
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-822-5354
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360

Iowa

Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-703-8712
Tulane University Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-988-6121

Maine

Rockport
Penobscot Bay Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670
Scarborough
Maine Medical Center- Scarborough Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8090
Maine Medical Partners Neurology
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670
South Portland
Maine Medical Partners - South Portland
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-888-8823
Columbia
Central Maryland Radiation Oncology in Howard County
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-546-1300
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-553-8100

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Flint
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Kalamazoo
Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net

Nebraska

Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-996-2879
Summit
Overlook Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 908-522-2043

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-220-4937
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Tualatin
Legacy Meridian Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-1742

Pennsylvania

Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-955-6084
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073

South Dakota

Pierre
Avera Cancer Institute at Pierre
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-322-3095
Sioux Falls
Avera Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-322-3095
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Texas

Houston
Memorial Hermann Texas Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-792-3245
San Antonio
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Washington

Vancouver
Legacy Cancer Institute Medical Oncology and Day Treatment
Status: ACTIVE
Contact: Site Public Contact
Legacy Salmon Creek Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

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.

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Andrew B. Lassman

  • Primary ID NRG-BN007
  • Secondary IDs NCI-2020-03404
  • Clinicaltrials.gov ID NCT04396860