Study on Nivolumab for Patients with IDH-Mutant Gliomas with and without High Mutation Levels

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03718767

Provider View

This clinical trial is testing the drug nivolumab to see if it can help control tumor growth in patients with IDH-mutant gliomas, a type of brain tumor, with and without high mutation levels. The study aims to determine if nivolumab can stop tumor growth and extend the time the tumor is controlled.

Patient Parameters

Program Overview

Gliomas are common brain tumors, and some have mutations in the IDH1 or IDH2 genes. When these tumors have many mutations, they are called hypermutator phenotype (HMP). Nivolumab is a drug that helps the immune system fight cancer. Researchers believe it might work better in gliomas with IDH mutations and HMP. This study will test nivolumab in patients with and without HMP to see if it can stop tumor growth and keep the tumor under control for longer.

Description

This study involves patients with IDH-mutant gliomas, a type of brain tumor. Some of these tumors have a high number of mutations, known as hypermutator phenotype (HMP). The study will test the drug nivolumab, which helps the immune system fight cancer, to see if it can stop tumor growth and keep the tumor under control for longer.

Participants will be screened with medical history, physical exams, heart, blood, and pregnancy tests, and brain MRI scans. They will also provide tumor samples. Participants will receive nivolumab through an IV in cycles. For the first four cycles, they will receive the drug on days 1 and 15. From cycles 5 to 16, they will receive it only on day 1.

After completing 16 cycles, participants will have follow-up visits over 100 days, including health questions, exams, and possibly a brain MRI. If their disease has not worsened, they may have imaging studies every 8 weeks for up to a year. Participants will be contacted every 6 months to check on their health.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with IDH1 or IDH2 mutated gliomas.
  • Must have a confirmed diagnosis of diffuse glioma by the NIH Laboratory of Pathology.
  • Must have a tumor mutation burden (TMB) test done at NIH.
  • Must provide tumor tissue or slides for molecular and immune profiling.
  • Must be able to tolerate an MRI with contrast.
  • Must have a Karnofsky performance score of 60% or higher.
  • Must have adequate organ and marrow function, including specific blood counts and liver and kidney function tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for 5 months after.

Exclusion Criteria

  • Currently receiving other investigational drugs.
  • History of receiving immune therapy.
  • Allergic reactions to similar drugs as nivolumab.
  • History of severe allergic reactions to monoclonal antibodies.
  • Prior invasive cancer unless disease-free for at least 3 years.
  • Active or history of autoimmune diseases that may affect vital organs or require immune suppressive treatment.
  • Currently on high doses of corticosteroids.
  • Uncontrolled illnesses that may interfere with study participation.
  • Known HIV-positive status.
  • Pregnant or breastfeeding women.

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