ClinicalTrials.gg
CompletedNCT03174197Updated Sep 23, 2026Results posted

Atezolizumab in Combination With Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

A Phase 1/2 interventional study of Atezolizumab and Radiation Therapy in Glioblastoma and Gliosarcoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase I/II trial studies the side effects and how well atezolizumab works in combination with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. 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. Drugs used in chemotherapy, 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. It is not yet known how well atezolizumab works in combination with temozolomide and radiation therapy in treating patients with glioblastoma.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the safety of atezolizumab in combination with radiation and temozolomide during the concurrent stage and in combination with temozolomide during the adjuvant stage. (Phase I) II. To evaluate the overall survival (OS) of atezolizumab in combination with radiation and temozolomide and in combination with temozolomide at onset of treatment. (Phase II)

SECONDARY OBJECTIVES:

I. To evaluate the overall response rate (ORR), duration of response, and progression free survival (PFS) of atezolizumab in combination with radiation and temozolomide during the treatment period.

CORRELATIVE OBJECTIVES:

I. Profiling tumor immune cell populations (example: immunohistochemistry [IHC] analyses of CD4, CD8, programmed death-1 [PD-1], programmed death-ligand 1 [PD-L1], and PD-L2).

II. Profiling of tumor deoxyribonucleic acid (DNA), messenger ribonucleic acid (mRNA), microRNA and epigenetic profiling (DNA methylation) and evaluation of whole exome sequencing, RNA sequencing, microRNA sequencing and cell-free circulating tumor DNA (ctDNA).

III. Peripheral blood collection for evaluation of circulating chemokines/cytokines.

OUTLINE: This is a phase I study followed by a phase II study.

PHASE I (CONCURRENT PHASE): Patients receive temozolomide orally (PO) daily on days 1-42 and atezolizumab intravenously (IV) over 30-60 minutes on day 1, 15, 29, and 42. Patients undergo radiation therapy (RT) 5 days per week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.

PHASE II (ADJUVANT PHASE): Patients receive temozolomide PO on days 1-5 and atezolizumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months.

02

Conditions studied

  • Glioblastoma
  • Gliosarcoma
03

In context

Glioblastoma

2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.

This study's enrollment of 60 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed form (ICF).
  • Ability and willingness to comply with the requirements of the study protocol.
  • Have confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma). will be required for diagnosis confirmation. Receipt of archival tissue is not required for the start of treatment.
  • Patients must have undergone surgery and must not have had any further treatment following surgery.
  • Have a performance status of >= 60 on the performance status (KPS).
  • A baseline brain magnetic resonance imaging (MRI) obtained no more than 14 days prior to study enrollment on a stable or tapering dose of no greater than 4 mg a day of dexamethasone for at least 5 days.
  • Patients must start treatment within 6 weeks of definitive resection.
  • (ANC) >= 1,500 /mcL.
  • >= 100,000 /mcL.
  • >= 9 g/dL or >= 5.6 mmol/L.
  • Serum creatinine OR measured or calculated ( [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) =\< 1.5 x (ULN) OR >= 60 mL/min for subject with creatinine levels > 1.5 x institutional ULN.
  • Serum total =\< 1.5 x ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels > 1.5 ULN.
  • (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x ULN.
  • (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) \</=1.5 x ULN.
  • All screening labs should be performed within 14 days (+ 3 working days) of treatment initiation.
  • Female subject of should have a negative serum pregnancy test within 14 days (+ 3 working days) of study enrollment.
  • Female subjects of childbearing potential should be willing to use 2 methods of or be surgically sterile, or abstain from heterosexual activity for the duration of the study. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male subjects should agree to use an adequate method of contraception during the course of the study.

Exclusion criteria

Exclusion Criteria:

  • Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded. Prior treatment with the Optune device will be excluded.
  • Is currently participating or has participated in any other newly diagnosed therapeutic trial before or after chemoradiation.
  • Any serious medical condition that interferes with adherence to study procedures.
  • Patients may not receive concomitant chemotherapy, hormonal therapy, immunotherapy, or radiotherapy while patients are on study.
  • other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0).
  • Has known , gliomatosis cerebri, extracranial disease, or multifocal disease. Subject has multifocal glioblastoma (GBM), defined as discrete sites of contrast enhancing disease without contiguous T2/fluid attenuated inversion recovery (FLAIR) abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit.
  • for undergoing MRIs.
  • Inability to comply with study and follow-up procedures.
  • History or risk of disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations; rash must cover less than 10% of body surface area (BSA); disease is well controlled at baseline and only requiring low potency topical (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%); no acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • History of (HIV) infection or active (chronic or acute) or infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. Patients will be sampled for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and will be referred to a virologist to monitor for HBV re-activation. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
  • Active tuberculosis.
  • Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1.
  • Received oral or IV antibiotics within 2 weeks prior to cycle 1, day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or ) are eligible.
  • Anticipation of need for a major surgical procedure during the course of the study.
  • Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to cycle 1, day 1 or at any time during the study and for 5 months after last dose of atezolizumab.
  • Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =\< 6, and prostate-specific antigen [PSA] =\< 10 mg/mL, etc.)
  • Prior treatment with , or anti-PD-L1 therapeutic antibody or pathway targeting agents.
  • Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-a or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1.
  • Treatment with systemic medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1. Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  • History of severe allergic, anaphylactic, or other reactions to chimeric or humanized antibodies or fusion proteins.
  • Patients with prior bone marrow transplantation or prior solid organ transplantation.
Terms in these criteria, in plain language(30)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Adjuvant phase (temozolomide, atezolizumab)

    Patients receive temozolomide PO on days 1-5 and atezolizumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

    Drug: Atezolizumab · Drug: Temozolomide

  • Experimental
    Concurrent phase (temozolomide, atezolizumab, RT)

    Patients receive temozolomide PO daily on days 1-42 and atezolizumab IV over 30-60 minutes on day 1, 15, 29, and 42. Patients undergo RT 5 days per week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.

    Drug: Atezolizumab · Radiation: Radiation Therapy · Drug: Temozolomide

Interventions

  • Given IV

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

  • RadiationRadiation Therapy

    Undergo RT

    Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

  • Given PO

    Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    The primary endpoint is overall survival. The historical median for similar patients was about 15 months.

    Time frame: Baseline to 21 months, follow up for 9 months.

  2. Dose-limiting Toxicities (DLTs) (Phase I)

    Will monitor time to DLT continuously using a Bayesian method that assumes the median time to DLT follows an Inverse gamma distribution and that the individual times to DLT follow an exponential distribution.

    Time frame: Up to 10 weeks

07

Results

Posted Sep 23, 2026

Participant flow

This study began enrollment in the NeuroOncology clinic at the MD Anderson Cancer Center on 30-Jun-2017.

Participant flow — Overall Study
MilestonePhase 1Phase 2
Started1050
Completed948
Not completed12
Withdrew: Adverse event02
Withdrew: Dose limiting toxicity10

Outcome measures

PrimaryOverall Survival (OS)

The primary endpoint is overall survival. The historical median for similar patients was about 15 months.

Time frame:
Baseline to 21 months, follow up for 9 months.
Reported as:
Median · Months
Overall Survival (OS)
MonthsPhase I & Phase II
Overall Survival (OS)18 (14.2 to 25.0)
PrimaryDose-limiting Toxicities (DLTs) (Phase I)

Will monitor time to DLT continuously using a Bayesian method that assumes the median time to DLT follows an Inverse gamma distribution and that the individual times to DLT follow an exponential distribution.

Time frame:
Up to 10 weeks
Reported as:
Count of participants · Participants
Dose-limiting Toxicities (DLTs) (Phase I)
ParticipantsPhase 1Phase 2
Dose-limiting Toxicities (DLTs) (Phase I)10

Adverse events

Collected over From baseline to study completion, participants were followed up with every 3 months after the last dose until deceased, or off study, up to 21 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 19/10 (90%)5/10 (50%)10/10 (100%)
Phase 242/50 (84%)15/50 (30%)50/50 (100%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventPhase 1Phase 2
Alanine aminotransferase increasedInvestigations1/101/50
Back painMusculoskeletal and connective tissue disorders1/100/50
Edema CerebralNervous system disorders1/102/50
Gait disturbanceGeneral disorders1/101/50
Generalized muscle weaknessMusculoskeletal and connective tissue disorders1/101/50
HyperglycemiaMetabolism and nutrition disorders1/101/50
PneumonitisRespiratory, thoracic and mediastinal disorders1/101/50
Wound infectionInfections and infestations1/100/50
Thromboembolic eventVascular disorders1/101/50
SeizureNervous system disorders0/104/50
Most frequent other events
Showing 10 of 153
Most frequent other events
EventPhase 1Phase 2
FatigueGeneral disorders10/1043/50
Lymphocyte count decreasedInvestigations6/1046/50
HyperglycemiaMetabolism and nutrition disorders3/1038/50
Alanine aminotransferase increasedInvestigations5/1031/50
ConstipationGastrointestinal disorders6/1027/50
NauseaGastrointestinal disorders6/1023/50
White blood cell decreasedInvestigations0/1028/50
HeadacheNervous system disorders2/1026/50
Memory impairmentNervous system disorders5/106/50
SeizureNervous system disorders5/1017/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase 1Phase 2Total
<=18 years011
Between 18 and 65 years83240
>=65 years21719
Age, Continuous
Age, Continuous(years)Phase 1Phase 2Total
Mean54.8 ± 16.458.4 ± 1257.8 ± 12.7
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1Phase 2Total
Female31619
Male73441
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1Phase 2Total
Hispanic or Latino055
Not Hispanic or Latino104353
Unknown or Not Reported022
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1Phase 2Total
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American000
White104656
More than one race000
Unknown or Not Reported033
Region of Enrollment
Region of Enrollment(participants)Phase 1Phase 2Total
United States105060
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Sep 2025, 98 months.

Results were first posted in Sep 2026, 1 year after primary completion.

Of 84 non-industry phase 1/2 interventional studies under Glioblastoma, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 102. This study's 98 months is above that.

Counting every sponsor, half of 137 studies reached it within 66 months; a quarter within 45 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2017
First posted
Jun 2, 2017
StartActual
Jun 30, 2017
Primary completionActual
Sep 17, 2025
CompletionActual
Sep 17, 2025
Results first posted
Sep 23, 2026
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03174197
Responsible party
Sponsor
First posted
Jun 2, 2017
Start date
Jun 30, 2017
Primary completion
Sep 17, 2025
Completion
Sep 17, 2025
Results posted
Sep 23, 2026
Last update
Sep 23, 2026

Study contacts

Shiao-Pei S Weathers
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Atezolizumab · Temozolomide

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