Nivolumab for Brain Tumors

Palo Alto (17 mi)

Fabio M. Iwamoto, MD, Cancer Care - at ...

Overseen byFabio Iwamoto, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fabio Iwamoto, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?The objective of this study is to determine response rates (partial and complete responses) to nivolumab of recurrent or progressive IDH mutant (grades 2, 3 or 4) gliomas with prior exposure to alkylating agents.

Eligibility Criteria

This trial is for adults with recurrent or progressive brain tumors (IDH mutant gliomas grades 2, 3, or 4) who have previously been treated with alkylating agents. Participants must be able to perform daily activities at a reasonable level (KPS of 60+), have measurable disease on MRI, and provide tumor samples. They need normal organ function tests and must consent to study requirements.

Inclusion Criteria

My brain tumor is aggressive, has an IDH mutation, and has worsened despite previous treatments.

I have a tumor in my brain that is visible and measures at least 10mm x 10mm on an MRI.

I am a woman who can have children and have a negative pregnancy test.

I am 18 years old or older.

I can care for myself but may need occasional assistance.

Exclusion Criteria

I have previously used specific inhibitors or checkpoint inhibitors.

I have been treated with bevacizumab or similar drugs before.

Treatment Details

The trial is testing the effectiveness of Nivolumab in treating IDH mutant gliomas that are recurring or worsening despite prior treatment. The main goal is to see how many patients experience partial or complete shrinkage of their tumors after receiving this drug.

1Treatment groups

Experimental Treatment

Group I: NivolumabExperimental Treatment1 Intervention

Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: