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Monoclonal Antibodies

Immunotherapy + Chemotherapy + Radiation for Glioblastoma

Phase 1 & 2

Waitlist Available

Led By Shiao-Pei S Weathers

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have undergone surgery and must not have had any further treatment following surgery

Have a performance status of >= 60 on the Karnofsky performance status (KPS)

Must not have

Received oral or IV antibiotics within 2 weeks prior to cycle 1, day 1

History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy, chemotherapy, and radiation therapy to treat patients with glioblastoma.

Who is the study for?

This trial is for patients with newly diagnosed glioblastoma who have had surgery but no other treatment. They must start treatment within 6 weeks of surgery, have adequate blood counts and organ function, not be pregnant or breastfeeding, agree to use contraception, and have a performance status indicating they can care for themselves.

What is being tested?

The study tests how well the combination of atezolizumab (an immune system-boosting drug), temozolomide (a chemotherapy drug), and radiation therapy works in treating glioblastoma. It's a phase I/II trial to assess side effects and effectiveness.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in organs, infusion-related reactions from atezolizumab; nausea, fatigue, hair loss from temozolomide; and skin irritation or damage to nearby tissues from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery for my condition and have not received any treatment since.

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I am mostly able to care for myself and carry out daily activities.

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My kidney function, measured by creatinine levels, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any antibiotics in the last 2 weeks.

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I have a history of lung scarring or inflammation.

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I have active tuberculosis.

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I expect to need a major surgery during the study.

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I have had cancer treatments directly in the tumor area but not Gliadel wafers or Optune device.

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I am currently being treated for an infection.

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I haven't taken any immune-boosting drugs in the last 6 weeks or five half-lives of the drug.

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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I have been treated with drugs targeting PD-1 or PD-L1.

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I have a history of HIV or active hepatitis B or C.

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I have a lung condition not caused by an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities (DLTs) (Phase I)

Incidence of adverse events

Overall survival (OS) (Phase II)

Secondary study objectives

Duration of response (DoR)

Overall response rate

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Concurrent phase (temozolomide, atezolizumab, RT)Experimental Treatment3 Interventions

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.

Group II: Adjuvant phase (temozolomide, atezolizumab)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Atezolizumab

2016

Completed Phase 3

~5860