Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma

NCT04729959 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: NCI-2021-00410NRG-BN010U10CA180868
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 110

Brief Summary

This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6), which is made by white blood cells and other cells in the body as well as certain types of cancer. This may help lower the body's immune response and reduce inflammation. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Fractionated stereotactic radiation therapy uses special equipment to precisely deliver multiple, smaller doses of radiation spread over several treatment sessions to the tumor. The goal of this study is to change a tumor that is unresponsive to cancer therapy into a more responsive one. Therapy with fractionated stereotactic radiotherapy in combination with tocilizumab may suppress the inhibitory effect of immune cells surrounding the tumor and consequently allow an immunotherapy treatment by atezolizumab to activate the immune response against the tumor. Combination therapy with tocilizumab, atezolizumab and fractionated stereotactic radiation therapy may shrink or stabilize the cancer better than radiation therapy alone in patients with recurrent glioblastoma.

Conditions

Diffuse Astrocytoma, IDH-Wildtype; Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (3)

• [Non-surgical Cohort] Maximum-tolerated Dose (Safety Run-In)

  The maximum tolerated dose (MTD) was defined as the highest prespecified dose level with an observed dose-limiting toxicity (DLT) rate of ≤33% of participants. MTD was determined during the safety run-in by testing increasing prespecified dose levels of tocilizumab alone and in combination with atezolizumab in Arms 1-3, with cohorts of 3 to 6 participants enrolled at each dose level. Dose escalation began with tocilizumab 4 mg/kg (Dose Level 1 / Arm 1), followed by tocilizumab 8 mg/kg (Dose Level 2 / Arm 2), and then tocilizumab 8 mg/kg in combination with atezolizumab 1680 mg (Dose Level 3 / Arm 3).

  From first dose of study drug through completion of Cycle 1 (28 days).

• [Non-surgical Cohort, Safety Run-In] Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

  DLTs per NCI CTCAE v5.0 include Grade ≥2 toxicity at least possibly related to study drug(s) that does not resolve to Grade ≤1 within 6 weeks of last dose with optimal management or prevents tapering corticosteroids to baseline (or pre-toxicity dose) within 6 weeks, excluding CNS toxicity due to intratumoral/peritumoral disease or edema that improves to Grade ≤2 within 7 days, cerebral edema improving per protocol, or endocrinopathy controlled by hormone replacement. Additional DLTs include Grade 4 immune-related AEs (excluding controlled endocrinopathy); Grade 3 hepatitis, pneumonitis, nephritis, myocarditis, pericarditis, encephalitis, myasthenia gravis, uveitis, episcleritis, peripheral neuropathy, autoimmune hemolytic anemia, acquired hemophilia, or autonomic neuropathy; recurrent Grade 2 pneumonitis; any-grade transverse myelitis; and hepatic or hematologic toxicity meeting protocol-specified criteria for dose modification or discontinuation.

  From first dose of study drug through completion of Cycle 1 (28 days).

• [Non-surgical Cohort] Objective Radiographic Response Rate (Phase II)

  Objective radiographic response rate (ORR) is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) on magnetic resonance imaging (MRI) using modified Response Assessment in Neuro-Oncology (RANO) criteria, compared with baseline MRI. CR is disappearance of all enhancing disease with no new lesions. PR is ≥50% decrease in enhancing tumor burden. Responses must be sustained for ≥4 weeks.

  Registration to 6 months

Secondary Outcomes (5)

• [Phase II Non-Surgical Cohort] Progression-free Survival

  Time from study enrollment to disease progression, death from any cause, or last evaluable MRI tumor assessment. Maximum follow-up time at time of analysis was 13.5 months.

• [Phase II Non-Surgical Cohort] Overall Survival

  From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months.

• [Surgical Cohort] Progression-free Survival

  Time from study enrollment to disease progression, death from any cause, or last evaluable MRI tumor assessment. Maximum follow-up time at time of analysis was 13.9 months.

• [Surgical Cohort] Overall Survival

  From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.9 months.

• Number of Participants by Highest Grade Adverse Event Reported

  From study enrollment to last follow-up. Maximum follow-up time at time of analysis was 13.5 months for non-surgical cohort Arm 4, 13.9 months for surgical cohort Arms A and B, and 23.5 months for the non-surgical safety run-in Arms 1-3.

Other Outcomes (1)

• [Surgical Cohort] Immune Response

  Baseline and cycle 2, day 1 (1 cycle = 4 weeks)

Study Arms (6)

Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab)

EXPERIMENTAL

The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.

Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Tocilizumab

Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab)

EXPERIMENTAL

Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.

Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Tocilizumab

Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab)

EXPERIMENTAL

The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Tocilizumab

Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab)

EXPERIMENTAL

Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Tocilizumab

Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab

EXPERIMENTAL

The surgical cohort is defined as patients with recurrent glioblastoma with a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days, followed by surgical resection 7-14 days after completion of FSRT. Beginning 21-42 days after surgery, patients receive atezolizumab plus tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study, and blood and tumor tissue are collected on study.

Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Tocilizumab

Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

EXPERIMENTAL

Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.

Biological: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging

Interventions

Atezolizumab BIOLOGICAL

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab); Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab); Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

Biospecimen Collection PROCEDURE

Undergo blood sample and tumor tissue collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab); Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab); Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab); Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab); Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab; Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

Conventional Surgery PROCEDURE

Undergo surgery

Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab); Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab); Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab); Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab); Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab; Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

Fractionated Stereotactic Radiation Therapy RADIATION

Undergo FSRT

Also known as: Fractionated Stereotactic Radiotherapy

Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab); Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab); Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab); Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab); Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab; Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab); Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab); Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab); Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab); Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab; Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

Tocilizumab BIOLOGICAL

Given IV

Also known as: Actemra, Avtozma, IL-6 receptor monoclonal antibodies: tocilizumab, Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer, MRA, R-1569, RoActemra, Tocilizumab-aazg, Tocilizumab-anoh, Tyenne

Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab); Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab); Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab); Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab); Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically proven diagnosis of glioblastoma, OR molecular diagnosis of glioblastoma per Consortium to Inform Molecular and Practical Approaches to Central Nervous System Tumor Taxonomy (c-IMPACT-NOW) criteria ("diffuse astrocytic glioma, IDH-wildtype, with molecular features of glioblastoma, World Health Organization \[WHO\] grade IV"; this requires presence of amplification of EGFR, whole chromosome 7 gain AND whole chromosome 10 loss, or TERT promoter mutation)
• Tumor that is in first recurrence following prior first-line radiation therapy (prior dose \>= 40 Gy)
• Note: Prior temozolomide, prior tumor-treating fields, and/or Gliadel wafers (if placed at initial tumor resection) are allowed, but none of these are required
• Unequivocal radiographic evidence of tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan within 21 days prior to registration
• Per radiation oncologist review of MRI within 21 days prior to registration, must have focus of progressive, contrast-enhancing tumor that is amenable to FSRT, defined as the following:
• At least 1 cm x 1 cm contrast-enhancing tumor that is no greater than 4 cm in largest dimension
• FSRT target is at least 0.5 cm from the optic chiasm and brainstem
• Note, multifocal disease (i.e., other sites of tumor beyond the tumor being targeted for FSRT) is allowed if the above criteria are met for the tumor that is the proposed target for FSRT
• Surgical cohort only (Phase II only):
• Must be a candidate for repeat surgery (significant debulking or gross total resection of the contrast enhancing area) as determined by the neurosurgeon or multidisciplinary team
• Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction \[MSPCR\] or quantitative polymerase chain reaction \[PCR\]) are acceptable)
• The following intervals from previous treatments to registration are required to be eligible:
• If prior radiation was \< 60 Gy, an interval of at least 12 weeks (84 days) must have elapsed since the completion of radiation therapy
• If prior radiation was \>= 60 Gy, an interval of least 6 months (182 days) must have elapsed since the completion of radiation therapy, unless the target lesion for FSRT is outside of the 80% isodose line of the original radiation plan
• At least 21 days from temozolomide

You may not qualify if:

• Known somatic tumor mutation in IDH1 or IDH2 gene. If not previously completed, sequencing of the IDH1 and IDH2 genes is not required to determine trial eligibility
• Known germline DNA repair defect (mismatch repair deficiency, POLE mutation, e.g.). If not previously completed, germline sequencing is not required to determine trial eligibility
• Diffuse leptomeningeal disease
• Known contrast-enhancing tumor in brainstem or spinal cord. If not previously completed, spinal imaging is not required to determine trial eligibility
• Patients with clinically significant mass effect or midline shift (e.g., 1-2 cm of midline shift)
• Prior bevacizumab therapy
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded from this trial. Otherwise, patients with prior or concurrent malignancy are eligible
• Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
• Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or pathway-targeting agents
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon \[IFN\]-alpha or interleukin \[IL\]-2) within 4 weeks prior to registration
• Treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to registration
• Systemic corticosteroids used to treat brain edema and/or related symptoms at a dose of \> 2 mg of dexamethasone (or equivalent) daily within 5 days prior to registration. Patients receiving systemic corticosteroids for other indications are excluded
• Patients with increased risk for gastrointestinal perforations including history of diverticulitis
• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Sponsors & Collaborators

• NRG Oncology: collaborator
• National Cancer Institute (NCI): lead

Study Sites (110)

Kaiser Permanente-Anaheim

Anaheim, California, 92806, United States

Location

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente-Ontario

Ontario, California, 91761, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente-San Diego Zion

San Diego, California, 92120, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

Location

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States

Location

UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States

Location

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

Location

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States

Location

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Logan Health Medical Center

Kalispell, Montana, 59901, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

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

New York, New York, 10032, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, 17901, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

Valley Medical Center

Renton, Washington, 98055, United States

Location

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, 98684, United States

Location

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

Location

Aspirus Cancer Care-Antigo-Volm Cancer Center

Antigo, Wisconsin, 54409, United States

Location

Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

Location

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Aspirus Cancer Care-Wausau

Wausau, Wisconsin, 54401, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

MeSH Terms

Conditions

Astrocytoma; Glioblastoma

Interventions

atezolizumab; Specimen Handling; Magnetic Resonance Spectroscopy; tocilizumab; Immunoglobulin G; Disulfides

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

215-574-3208

Study Officials

• Stephen J Bagley

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: January 29, 2021
• Study Start: March 11, 2022
• Primary Completion: June 15, 2025
• Study Completion (Estimated): August 20, 2027
• Last Updated: September 23, 2026
• Results First Posted: August 7, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (110)