Study on Advancing Glioblastoma Treatment with Nivolumab and Relatlimab

Sponsor: Duke University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06816927

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This clinical trial is exploring a new treatment approach for patients with newly diagnosed glioblastoma, a type of brain cancer. The study is testing the safety and effectiveness of using two immunotherapy drugs, nivolumab and relatlimab, alongside standard treatments.

Patient Parameters

Program Overview

The GIANT study is a phase 2 clinical trial that aims to test the safety and effectiveness of two immunotherapy drugs, nivolumab and relatlimab, in patients with newly diagnosed glioblastoma (ndGBM). The trial will investigate whether these drugs can be safely combined with standard treatments like radiation and chemotherapy to improve outcomes for patients. The study will also look at how these drugs affect the cancer cells and the immune system.

Description

This study is designed to test a new treatment approach for glioblastoma, a type of aggressive brain cancer. The trial will include patients who have not yet received radiation or chemotherapy for their glioblastoma. Participants will undergo a biopsy to confirm their diagnosis and then be divided into groups to receive different treatments.

In the first part of the study, small groups of patients will receive nivolumab and relatlimab along with radiation and chemotherapy to ensure the treatment is safe. Once safety is confirmed, patients will be randomly assigned to receive either nivolumab alone or a combination of nivolumab and relatlimab before their surgery to remove the tumor.

After surgery, all patients will receive additional treatment with radiation and chemotherapy, along with nivolumab and relatlimab. The study will monitor the safety of these treatments and their effects on the cancer and the immune system. Patients will be followed for two years to assess their health and the treatment's impact.

The main goals of the study are to determine if the treatment is safe and to see if it can effectively target the cancer cells. Researchers will also evaluate the overall survival and quality of life of the participants.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Newly diagnosed with glioblastoma based on MRI or previously diagnosed but not treated with radiation or chemotherapy.
  • Require surgery to remove the tumor.
  • Willing to undergo planned surgical procedures.
  • Meet specific health criteria, including adequate blood counts and organ function.
  • Able to undergo MRI scans.
  • Agree to use effective contraception during the study and for six months after the last dose of treatment.
  • Negative tests for HIV, hepatitis B, and hepatitis C.
  • Able to adhere to the study schedule and requirements.

Exclusion Criteria

  • Tumors that cannot be completely removed by surgery.
  • Tumors located in certain areas of the brain, such as the cerebellum or brainstem.
  • Require urgent surgery for complications like swelling or fluid buildup in the brain.
  • Unable or unwilling to undergo MRI scans.
  • History of certain medical conditions, such as recent stroke or autoimmune diseases.
  • Previous treatment with immunotherapy.
  • Currently taking certain medications, like blood thinners or immunosuppressants.
  • Active infections or recent severe infections.
  • Pregnant or breastfeeding individuals.
  • History of other cancers requiring active treatment, except for certain skin cancers or cervical cancer in situ.
  • Any condition that may interfere with the study or pose a risk to the patient.

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