Study on Nivolumab and Stereotactic Radiosurgery With or Without Ipilimumab for Treating Recurrent Grade II-III Meningioma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03604978

Provider View

This clinical trial is exploring the safety and effectiveness of combining nivolumab, a type of immunotherapy, with a specialized radiation treatment for patients with grade II-III meningioma that has returned after previous treatment. The study also examines if adding another immunotherapy drug, ipilimumab, improves outcomes.

Patient Parameters

Program Overview

This study aims to find the best dose and assess the safety of nivolumab when used with a precise form of radiation therapy called multi-fraction stereotactic radiosurgery. It also evaluates how well this combination works, with or without the addition of ipilimumab, in treating patients with recurrent grade II-III meningioma. These immunotherapy drugs may help the immune system attack cancer cells and prevent them from growing and spreading. The radiation therapy targets the tumor with high precision, potentially causing less damage to surrounding healthy tissue.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of nivolumab when combined with stereotactic radiosurgery, with or without ipilimumab, for treating recurrent high-grade meningioma. In Phase II, the focus will be on how well this treatment works in shrinking tumors.

Participants will be divided into two groups:

  • Cohort A: Patients receive nivolumab through an IV every 28 days for up to a year, along with stereotactic radiosurgery on specific days.
  • Cohort B: Patients receive nivolumab every two weeks for six months, then every four weeks for another six months, along with ipilimumab every six weeks for four doses. They also undergo stereotactic radiosurgery on specific days.

Throughout the study, participants will have regular brain scans and blood tests to monitor their health and the treatment's effects. An echocardiogram may be performed if needed. After completing the treatment, patients will be followed up for 100 days to check on their progress.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of grade II-III meningioma that has returned after previous radiation treatment.
  • Have at least one measurable tumor on a brain MRI.
  • Have had at least one prior surgery with available tumor samples.
  • Be 18 years or older.
  • Be in good overall health with a performance status score of 0 to 2.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Agree to use effective contraception during the study and for a specified period after treatment.
  • Be able to understand and sign a consent form, or have a legally authorized representative do so.

Exclusion Criteria

  • Have had chemotherapy or radiation therapy within a certain period before the study.
  • Have not fully recovered from previous cancer treatments.
  • Are currently receiving other investigational treatments.
  • Have a history of severe allergic reactions to similar drugs.
  • Are using immunosuppressive medications, with some exceptions.
  • Have uncontrolled illnesses or infections.
  • Are pregnant or breastfeeding.
  • Have active or a history of certain autoimmune diseases.
  • Have had an organ transplant.
  • Have other severe medical conditions that could interfere with the study.
  • Have received a live vaccine recently.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.