Open-Label Phase II Study of Nivolumab for Adults with Progressive or Returning Meningioma

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02648997

Provider View

This clinical trial is exploring the use of immunotherapy drugs, nivolumab and ipilimumab, to treat meningioma that has returned or is not responding to treatment. The study aims to see if these drugs can help stop the growth of meningioma tumors.

Patient Parameters

Program Overview

This study is testing the safety and effectiveness of the immunotherapy drug nivolumab, either alone or combined with another drug called ipilimumab, in treating meningioma that has come back or is not responding to treatment. Both drugs are antibodies that help the immune system fight cancer cells. While nivolumab is approved for other cancers, it is not yet approved for meningioma. The study will help determine if these drugs can be effective for this type of tumor.

Description

This clinical trial is a Phase II study, which means it is focused on testing how safe and effective the treatment is. The study involves two groups: one group will receive nivolumab alone, and the other group will receive a combination of nivolumab and ipilimumab. These drugs are designed to help the immune system target and destroy cancer cells.

Nivolumab and ipilimumab have been used in other studies and have shown promise in stopping the growth of meningioma cells. Although nivolumab is approved for other types of cancer, it is not yet approved for meningioma, and the combination with ipilimumab is also not approved for this specific condition.

Participants will be monitored closely to see how well the treatment works and to check for any side effects. The study will provide important information about whether these drugs can be a new treatment option for meningioma.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of meningioma (grades I, II, or III) that is growing or has returned. Tumors that have spread are allowed. Grade I tumors must have failed radiation therapy.
  • No limit on the number of previous surgeries, radiation treatments, or other therapies.
  • Must have waited at least 12 weeks after radiation therapy unless there is new tumor growth outside the treated area.
  • Must have waited at least 28 days after surgery and fully recovered.
  • Must have waited at least 7 days after a biopsy.
  • Must be at least 4 weeks from other chemotherapy or biologic therapies.
  • Must have recovered from any significant side effects of previous treatments.
  • Be 18 years or older.
  • Have a performance status score of 70 or higher, indicating the ability to care for oneself.
  • Have adequate organ and bone marrow function based on specific blood tests.
  • Have a recent MRI or CT scan showing the tumor.
  • Be able to understand and agree to the study requirements, including signing a consent form.
  • For certain patients, must be eligible for additional radiation therapy.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study.

Exclusion Criteria

  • Participating in another study with an investigational drug or device.
  • Tumors located in the brainstem or spinal cord.
  • Significant bleeding in the tumor area unless stable.
  • Recent use of certain immunosuppressive treatments.
  • Previous treatment with PD-1, PD-L1, or CTLA-4 therapies.
  • Recent major surgery or injury.
  • Use of other investigational agents.
  • High-dose steroid use recently.
  • Recent live vaccine.
  • Uncontrolled medical conditions or other cancers needing treatment.
  • Active lung disease or serious medical disorders.
  • Active autoimmune disease needing treatment.
  • Active infection needing IV therapy.
  • Positive for hepatitis B or C.
  • History of severe allergic reactions to study drugs.
  • Pregnant or breastfeeding women.
  • History of HIV or AIDS.
  • Prisoners or involuntarily incarcerated individuals.

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