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Pembrolizumab + Standard Therapy for Glioblastoma

Phase 2

Waitlist Available

Led By Ian F. Parney, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Histological confirmation of supratentorial glioblastoma (also known as astrocytoma grade IV, gliosarcoma)

Must not have

History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs; NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab in combination with standard therapy (temozolomide and radiation therapy) to see if it can help treat patients with glioblastoma by killing tumor cells.

Who is the study for?

Adults with confirmed glioblastoma or astrocytoma grade IV, who can provide consent and samples for research. They must have adequate organ function, no severe diseases that could interfere with the trial, not be pregnant or nursing, agree to use contraception if of childbearing potential, and be willing to return for follow-up. Excluded are those with recent heart issues, active autoimmune disease requiring treatment in the past 2 years (except certain conditions), current pneumonitis or infections, HIV on antiretroviral therapy, other cancers being treated within 5 years.

What is being tested?

The trial is testing pembrolizumab combined with standard therapies including temozolomide chemotherapy and radiation therapy against glioblastoma tumors. Pembrolizumab is an immunotherapy drug designed to boost the body's immune response against cancer cells.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs like lungs (pneumonitis) or liver (hepatitis), skin reactions, hormone gland problems (like thyroid disorders), infusion reactions; plus typical chemo-radiation side effects like fatigue, nausea/vomiting, hair loss.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My diagnosis is glioblastoma in the brain.

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I have a brain tumor that can be mostly removed by surgery, confirmed by MRI and biopsy.

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I am willing to have brain surgery at Mayo Clinic in Rochester, MN.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My hemoglobin level is at least 9.0 g/dL without recent transfusions or EPO.

Exclusion Criteria

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

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I have not had a heart attack in the last 6 months and do not need ongoing therapy for severe heart rhythm problems.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have had pneumonitis treated with steroids or have it now.

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I understand the study drug's effects on unborn babies are unknown.

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I am not willing to use birth control.

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I am experiencing severe headaches, nausea, or a decrease in consciousness due to increased pressure in my brain.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not taking any experimental drugs for my cancer.

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I have active hepatitis B or C.

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I have an active tuberculosis infection.

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I have not received a live vaccine in the last 30 days.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have not had any other cancer within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of dose limiting toxicities (DLT) (Group 1)

Overall survival (OS) (Group 2)

Secondary study objectives

Incidence of adverse events

Progression-free survival (Group 2)

Time to progression (Group 2)

+4 more

Other study objectives

Biomarkers

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: Group 2 (pembrolizumab, temozolomide, radiation therapy )Experimental Treatment5 Interventions

CONCURRENT (CYCLE 1): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLES 2-6): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 of cycles 2-5 and 1 and 22 of cycle 6 (up to a total of 17 doses). Patients also receive temozolomide PO daily on days 1-5, 29-33, and 57-61 of cycles 2 and 6, days 22-26 and 50-54 of cycle 3, days 15-19 and 43-47 of cycle 4, days 8-12 and 36-40 of cycle 5. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.

Group II: Group 1 (pembrolizumab, surgery, temozolomide, radiation)Experimental Treatment6 Interventions

NEOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1. SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7. CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Pembrolizumab

2017

Completed Phase 3

~3150