Chemoimmunotherapy for Glioblastoma

Overseen By Donald Miller, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Louisville

Must be taking: Temozolomide

Must not be taking: Immunotherapy

Disqualifiers: Prior malignancy, Stroke, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 13

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to test the safety of Pembrolizumab and Temozolomide in treating recurrent glioblastoma and to characterize the effect of this treatment on the participants tumor and immune system..

Research Team

Donald Miller, MD

Principal Investigator

University of Louisville/James Graham Brown Cancer Ctr.

Eligibility Criteria

This trial is for adults with confirmed glioblastoma, limited to the brain's upper part, who have completed standard chemoradiation. They must have adequate blood counts and organ function, no more than three prior treatments for high-grade glioma, and be able to consent. Women of childbearing age must test negative for pregnancy and use birth control; men also need contraception.

Inclusion Criteria

I have had 3 or fewer treatments for my high-grade brain tumor.

The original tumor sample from my diagnosis is available for review.

I can understand and am willing to sign the consent form.

Exclusion Criteria

I have previously received immunotherapy, like a vaccine or dendritic cell vaccine.

I have not had cancer (other than non-melanoma skin cancer) in the last 3 years.

Severe, active co-morbidity: Transmural myocardial infarction or unstable angina within the last 6 months prior to registration, History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months prior to registration, Significant vascular disease, Known history of Tuberculosis or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, Patients with active autoimmune disease or history of autoimmune disease that might recur, Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy, Is pregnant or breastfeeding, Has received prior therapy with an anti-Programmed Death 1 (PD-1), anti- Programmed Death-ligand 1 (PD-L1), or anti- Programmed Death-ligand 1 (PD-L2) agent, Patient must have < 1.5 cm midline shift pre-operative, History of severe hypersensitivity reaction to any monoclonal antibody including pembrolizumab, Patients who cannot safely undergo MRI due to non-MRI compatible pacemaker, or other reason

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Neoadjuvant Treatment

Participants receive one cycle of Temozolomide and Pembrolizumab prior to tumor removal

3 weeks

1 visit (in-person)

Post-surgical Treatment

Participants receive three weekly cycles of Temozolomide and Pembrolizumab until progression

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Every 8 weeks

Treatment Details

Interventions

• Pembrolizumab
• Temozolomide

Trial Overview The study tests Pembrolizumab combined with Temozolomide's safety in treating recurrent glioblastoma. It aims to understand how this combination affects the tumor and immune system of participants.

Participant Groups

Group I: temozolomide Experimental Treatment 1 Intervention

Participants will take Temozolomide pills at home at a dose determined by body weight. They will take the pills for five days every 3 weeks. It will be dispensed by the pharmacy and must be stored in a closed container at room temperature, away from heat, moisture, and direct light and kept from freezing. It will be kept out of the reach of children. Outdated medicine or medicine no longer needed will be returned to the Brown Cancer Center pharmacy for disposal.

Group II: Pembrolizumab Experimental Treatment 1 Intervention

Pembrolizumab will be administered at a dose of 200 mg as an IV infusion through a freely flowing IV. The diluted solution will be administered intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. Other drugs will not be co-administered through the same infusion line. Pembrolizumab doses will be repeated every three weeks.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+