Pembrolizumab + Standard Therapy for Glioblastoma

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 the 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. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.

Research Team

Ian F. Parney, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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.

Inclusion Criteria

Albumin >= 2.5 mg/dL (obtained =< 28 days prior to registration)

Provide written informed consent

My cancer is a Grade IV IDH-mutant astrocytoma.

Exclusion Criteria

I have had skin cancer (not melanoma) or early-stage cervical cancer.

You have used or plan to use the Optune device.

I am currently breastfeeding.

Treatment Details

Interventions

• External Beam Radiation Therapy (Radiation)
• Laboratory Biomarker Analysis (Other)
• Pembrolizumab (Checkpoint Inhibitor)
• Radiation Therapy (Radiation)
• Temozolomide (Alkylating agents)
• Therapeutic Conventional Surgery (Procedure)

Trial Overview 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.

Participant Groups

Group I: Group 2 (pembrolizumab, temozolomide, radiation therapy ) Experimental Treatment 5 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 Treatment 6 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.

External Beam Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+