GlioblastomaPhase 2NCT04817254
Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
A Phase 2 study testing TMZ, ipilimumab 3mg/kg and Nivolumab in people with Glioblastoma and Gliosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma, Malignant Glioma
- What is being tested?
- TMZ, ipilimumab 3mg/kg and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2021to 20 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Participants must have newly diagnosed histologically confirmed primary glioblastoma or gliosarcoma
- Participants must have undergone an extensive resection of unifocal, confined to the supratentorial compartment, tumor.
- Participant must have completed chemoradiation (external beam radiation with concurrent temozolomide) a maximum of 5 weeks prior to initiation of study therapy. Potential participants who have a limited short term, reversable, unrelated to their underlying disease, concurrent illness, the initiation of treatment may be delayed up to 14 days, if the participant meet all other I/E criteria at that time.
- Age greater than or equal to 18 years.
- Karnofsky greater than or equal to 70%
- Participants must have adequate organ and marrow function as defined below:
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- Absolute neutrophil count greater than or equal to 1,500/mcL
- Platelet Count >100,000/mcL
- Hemoglobin > 9.0 g/dL (may be transfused to achieve this level)
- BUN less than or equal to 30 mg/dL
- Serum creatinine less than or equal to 1.7 mg/dL or creatinine clearance as measured by 24 hour urine collection as > 60 ml/min.
- Total bilirubin (except participants with Gilbert s Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) less than or equal to 2.0 mg/dL
- ALT and AST less than or equal to 2.5x institutional upper limit of normal.
- The effects of study treatment on the developing human fetus are unknown. For this reason, participants of reproductive potential must agree to abstinence or use adequate contraception which includes a combination of TWO of the following:
- Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm, or cervical cap with spermicide
- IUD
- Hormone-based contraceptive
- Tubal ligation
- Note: Consider use in individuals of child-bearing potential (IOCBP) only or both individuals who can father children and IOCBP starting from the enrollment and for the duration of study treatment and up to 6 months (IOCBP) after the last dose of study drug and 6 months (if individual can father children) after the last dose of temozolomide. Should a IOCBP become pregnant or suspect pregnancy while the individual or partner is participating in this study, the individual should inform the treating physician immediately.
- -The participant must be able to understand and be willing to sign a written informed consent document.
Who cannot join
- Definitive clinical or radiologic evidence of progressive disease.
- Prior placement of Gliadel wafer or local brachytherapy. Note: Tumor Treating Fields are allowed.
- Participants who are receiving any other investigational agents.
- Participants who have a history of receiving immune therapy, such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, ipilimumab or temozolomide.
- History of allergic reactions attributed to gadolinium contrast.
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- History of severe hypersensitivity reaction to any monoclonal antibody.
- Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants 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. These include but are not limited to participants with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or CIDP, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease
- (IBD), Crohn s, ulcerative colitis, and hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome. Such diseases should be excluded because of the risk of recurrence or exacerbation of disease.
- Note: Participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Participants with rheumatoid arthritis and other arthropathies, Sjogren s syndrome, psoriasis controlled with topical medication, and participants with positive serology, such as antinuclear antibodies (ANA) and anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
- The participant must not be currently on a corticosteroid dose greater than physiologic replacement dosing defined as 30 mg of cortisone per day or its equivalent. Participants must have stopped corticosteroids above this threshold at least 7 days prior to initiation of study treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (within timeframes identified in the bullets below) that
- would limit compliance with study requirements.
- Individual who are pregnant are excluded from this study because study treatment potential for teratogenic or abortifacient effects is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to study treatment of the mother, breastfeeding should be discontinued.
- Known active, chronic, or history of hepatitis infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Trial Evaluating the Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
Background:
Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more.
Read more
Objective:
To study people with newly diagnosed GBM or gliosarcoma to look at the changes in immune cells in the blood of those who take ipilimumab and nivolumab, along with temozolomide.
Eligibility:
Adults ages 18 and older with newly diagnosed GBM or gliosarcoma, who have had surgical removal of their tumor and have completed standard initial chemotherapy and radiation therapy.
Design:
Participants will be screened with the following:
Medical record review
Medical history
Physical exam
Tests to assess their nervous system and their ability to do typical activities
Blood tests
Tumor assessment. For this, they will have magnetic resonance imaging (MRI). They may get a contrast dye through an intravenous (IV) catheter. The MRI scanner makes noise. They will get earplugs.
Electrocardiogram. It measures heart rate and rhythm. They will lie still. Sticky pads will be placed on their chest, arms, and legs.
Screening tests will be repeated during the study.
Treatment will be given in cycles. Each cycle lasts 4 weeks. Participants will get nivolumab and ipilimumab via IV. They will take temozolomide by mouth. They will keep a pill diary.
Participants will fill out surveys about their symptoms.
Participants will have follow-up visits about 60 days and 100 days after treatment ends. Then they will be contacted every 6 months for the rest of their life.
Read the detailed description
Background:
Glioblastoma (GBM) represents an aggressive malignancy with limited therapeutic options. The immunosuppressive nature of GBM may be reversible with immune checkpoint inhibitor (ICI) treatment, however, initial studies have yet to demonstrate this. It is postulated that trafficking of peripherally activated lymphocytes may play a role in generating a robust intracranial immune response. Therefore, a blood-based assay to identify peripheral blood response may both predict response and better identify the ideal patient populations for future ICI clinical trials.
Objectives:
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes.
Eligibility:
Histologically confirmed, newly diagnosed primary glioblastoma or gliosarcoma;
Age greater than or equal to 18 years;
Adequate organ function;
Karnofsky performance score greater than or equal to 70;
Subjects must recently complete resection and chemoradiation;
Subjects must not have prior immunotherapy, other current investigational agents, or corticosteroid treatment > 30mg cortisone-equivalents per day.
Design:
Open-label, investigator-initiated exploratory study of newly-diagnosed GBM who have completed resection and chemoradiation.
Participants will be randomized to be treated in Arm 1 or 2, consistent of adjuvant chemotherapy (temozolomide (TMZ)) and immunotherapy (nivolumab + ipilimumab):
TMZ (150-200 mg/m2 PO on days 1-5 q28 days for cycles 1-6)
Arm 1:
Nivolumab (1 mg/kg IV q2weeks for cycles 1-4, then 480 mg IV q4weeks for cycles 5-16) + ipilimumab (1 mg/kg IV q4 weeks for cycles 1-4)
Arm 2:
Nivolumab (1 mg/kg IV q2weeks for cycles 1-4, then 480 mg IV q4weeks for cycles 5-16) + ipilimumab (3 mg/kg IV q4 weeks for cycles 1-4)
For the primary objective, serial examination of peripheral blood, including comprehensive flow cytometric analysis of leukocyte populations and cytokines, and Interferon- >= (IFN- >=) ELISPOT functional analysis of CD4+/8+ response to common recall antigens will be used to determine systemic response to ICI treatment.
For the secondary objectives, correlative studies assess peripheral blood T cells' ability to respond to an in vitro stimulation paradigm, including nivolumab and ipilimumab, in a microbead-based model. The T cell response to pretreatment in vitro stimulation would be compared to post-treatment in vivo stimulation to determine if this in vitro model can predict in vivo response.
Additional exploratory studies are planned to characterize the in vivo immune response to adjuvant chemotherapy and immunotherapy, including but not limited to:
Phospho-flow functional analysis of NK cell response to IFN/IL-15 stimulation.
- Conditions
- Glioblastoma, Gliosarcoma, Malignant Glioma
- Being tested
- TMZ, ipilimumab 3mg/kg, Nivolumab, ipilimumab 1mg/kg
- Keywords
- Brain Cancer, Quality of Life
- Medical subject headings
- Glioblastoma, Gliosarcoma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMZDrug
150 mg/m2 on days 1-5 of cycles 1-6
ipilimumab 3mg/kgDrug
3 mg/kg q 4 weeks for cycles 1-4
NivolumabDrug
1 mg/kg IV q2weeks for cycles 1-4, then 480 mg q 4 weeks for cycles 5-16
ipilimumab 1mg/kgDrug
1 mg/kg q 4 weeks for cycles 1-4
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Nivolumab + Ipilimumab 1mg/kg + TMZ Receives: Drug: TMZ; Drug: Nivolumab; Drug: ipilimumab 1mg/kg |
| Arm 2 | Experimental | Nivolumab + Ipilimumab 3mg/kg + TMZ Receives: Drug: TMZ; Drug: ipilimumab 3mg/kg; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes.
Correlation between the Median amount of time subject survives after therapy and quantitative analysis of peripheral blood T lymphocytes.
Measured: death
Secondary outcomes (5)
Determine if the T cell response measured by the ex vivo tosylactivated bead assay correlates with subsequent systemic response to treatment with immune checkpoint inhibitors.
Correlation between T cell response to immune checkpoint inhibitors and survival
Measured: Baseline, Day 1 of each Cycle and 60 day and 100 day post treatment
Determine if T cell response to immune checkpoint inhibitors measuring the change in the pre-treatment and post-treatment blood correlates with progression-free survival
Measurement of pretreatment and posttreatment blood correlates and its correlation T cell response to checkpoint inhibitors.
Measured: disease progression
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with progression-free survival, evaluating 2 different dosing regimens of the ICIs.
Correlation between T cell response with varying dose regimen of immune checkpoint inhibitors and disease progression
Measured: disease progression
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with overall survival, evaluating 2 different dosing regimens of the ICIs.
Correlation between T cell response with varying dose regimen of immune checkpoint inhibitors and death
Measured: death
Evaluate changes in patient reported outcome measures using self-reported symptom severity and interference with daily activities using the MDASI-BT with treatment response and progression-free and overall survival.
Proportion of patients that have an improvement in quality of life
Measured: Study Calendar, last collection of QOL Questioner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start8 Dec 2021
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817254
- Sponsor's protocol ID
- 210015
- Other IDs
- 21-C-0015
- Status last verified
- 15 Apr 2026
- First submitted
- 25 Mar 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@CTA: All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Evaluating the Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
- ClinicalTrials.gov ID
- NCT04817254
- Acronym / sponsor ID
- 210015
- Conditions
- Glioblastoma, Gliosarcoma, Malignant Glioma
- Keywords
- Brain Cancer, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more.
Objective:
To study people with newly diagnosed GBM or gliosarcoma to look at the changes in immune cells in the blood of those who take ipilimumab and nivolumab, along with temozolomide.
Eligibility:
Adults ages 18 and older with newly diagnosed GBM or gliosarcoma, who have had surgical removal of their tumor and have completed standard initial chemotherapy and radiation therapy.
Design:
Participants will be screened with the following:
Medical record review
Medical history
Physical exam
Tests to assess their nervous system and their ability to do typical activities
Blood tests
Tumor assessment. For this, they will have magnetic resonance imaging (MRI). They may get a contrast dye through an intravenous (IV) catheter. The MRI scanner makes noise. They will get earplugs.
Electrocardiogram. It measures heart rate and rhythm. They will lie still. Sticky pads will be placed on their chest, arms, and legs.
Screening tests will be repeated during the study.
Treatment will be given in cycles. Each cycle lasts 4 weeks. Participants will get nivolumab and ipilimumab via IV. They will take temozolomide by mouth. They will keep a pill diary.
Participants will fill out surveys about their symptoms.
Participants will have follow-up visits about 60 days and 100 days after treatment ends. Then they will be contacted every 6 months for the rest of their life.
Detailed description
Background:
Glioblastoma (GBM) represents an aggressive malignancy with limited therapeutic options. The immunosuppressive nature of GBM may be reversible with immune checkpoint inhibitor (ICI) treatment, however, initial studies have yet to demonstrate this. It is postulated that trafficking of peripherally activated lymphocytes may play a role in generating a robust intracranial immune response. Therefore, a blood-based assay to identify peripheral blood response may both predict response and better identify the ideal patient populations for future ICI clinical trials.
Objectives:
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes.
Eligibility:
Histologically confirmed, newly diagnosed primary glioblastoma or gliosarcoma;
Age greater than or equal to 18 years;
Adequate organ function;
Karnofsky performance score greater than or equal to 70;
Subjects must recently complete resection and chemoradiation;
Subjects must not have prior immunotherapy, other current investigational agents, or corticosteroid treatment > 30mg cortisone-equivalents per day.
Design:
Open-label, investigator-initiated exploratory study of newly-diagnosed GBM who have completed resection and chemoradiation.
Participants will be randomized to be treated in Arm 1 or 2, consistent of adjuvant chemotherapy (temozolomide (TMZ)) and immunotherapy (nivolumab + ipilimumab):
TMZ (150-200 mg/m2 PO on days 1-5 q28 days for cycles 1-6)
Arm 1:
Nivolumab (1 mg/kg IV q2weeks for cycles 1-4, then 480 mg IV q4weeks for cycles 5-16) + ipilimumab (1 mg/kg IV q4 weeks for cycles 1-4)
Arm 2:
Nivolumab (1 mg/kg IV q2weeks for cycles 1-4, then 480 mg IV q4weeks for cycles 5-16) + ipilimumab (3 mg/kg IV q4 weeks for cycles 1-4)
For the primary objective, serial examination of peripheral blood, including comprehensive flow cytometric analysis of leukocyte populations and cytokines, and Interferon- >= (IFN- >=) ELISPOT functional analysis of CD4+/8+ response to common recall antigens will be used to determine systemic response to ICI treatment.
For the secondary objectives, correlative studies assess peripheral blood T cells' ability to respond to an in vitro stimulation paradigm, including nivolumab and ipilimumab, in a microbead-based model. The T cell response to pretreatment in vitro stimulation would be compared to post-treatment in vivo stimulation to determine if this in vitro model can predict in vivo response.
Additional exploratory studies are planned to characterize the in vivo immune response to adjuvant chemotherapy and immunotherapy, including but not limited to:
Phospho-flow functional analysis of NK cell response to IFN/IL-15 stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: TMZ, Drug: Nivolumab, Drug: ipilimumab 1mg/kgNivolumab + Ipilimumab 1mg/kg + TMZ |
| Arm 2 | Experimental | Drug: TMZ, Drug: ipilimumab 3mg/kg, Drug: NivolumabNivolumab + Ipilimumab 3mg/kg + TMZ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must have newly diagnosed histologically confirmed primary glioblastoma or gliosarcoma
- Participants must have undergone an extensive resection of unifocal, confined to the supratentorial compartment, tumor.
- Participant must have completed chemoradiation (external beam radiation with concurrent temozolomide) a maximum of 5 weeks prior to initiation of study therapy. Potential participants who have a limited short term, reversable, unrelated to their underlying disease, concurrent illness, the initiation of treatment may be delayed up to 14 days, if the participant meet all other I/E criteria at that time.
- Age greater than or equal to 18 years.
- Karnofsky greater than or equal to 70%
Key exclusion criteria (16 listed)
- Definitive clinical or radiologic evidence of progressive disease.
- Prior placement of Gliadel wafer or local brachytherapy. Note: Tumor Treating Fields are allowed.
- Participants who are receiving any other investigational agents.
- Participants who have a history of receiving immune therapy, such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, ipilimumab or temozolomide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMZ150 mg/m2 on days 1-5 of cycles 1-6 | Drug | Arm 1, Arm 2 |
| ipilimumab 3mg/kg3 mg/kg q 4 weeks for cycles 1-4 | Drug | Arm 2 |
| Nivolumab1 mg/kg IV q2weeks for cycles 1-4, then 480 mg q 4 weeks for cycles 5-16 | Drug | Arm 1, Arm 2 |
| ipilimumab 1mg/kg1 mg/kg q 4 weeks for cycles 1-4 | Drug | Arm 1 |
Primary outcome
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes.
Time frame: death
Correlation between the Median amount of time subject survives after therapy and quantitative analysis of peripheral blood T lymphocytes.
5 secondary outcomes
Determine if the T cell response measured by the ex vivo tosylactivated bead assay correlates with subsequent systemic response to treatment with immune checkpoint inhibitors.
Time frame: Baseline, Day 1 of each Cycle and 60 day and 100 day post treatment
Determine if T cell response to immune checkpoint inhibitors measuring the change in the pre-treatment and post-treatment blood correlates with progression-free survival
Time frame: disease progression
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with progression-free survival, evaluating 2 different dosing regimens of the ICIs.
Time frame: disease progression
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with overall survival, evaluating 2 different dosing regimens of the ICIs.
Time frame: death
Evaluate changes in patient reported outcome measures using self-reported symptom severity and interference with daily activities using the MDASI-BT with treatment response and progression-free and overall survival.
Time frame: Study Calendar, last collection of QOL Questioner
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@CTA: All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin A Camphausen, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMZ, ipilimumab 3mg/kg and Nivolumab in people with Glioblastoma and Gliosarcoma, run by National Cancer Institute (NCI) at 1 site 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 20 inclusion and 16 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 17 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 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes. (time frame: death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.