Nivolumab for Brain Cancer

This trial explores a new method to treat aggressive brain tumors, specifically high-grade gliomas, using a special version of the drug nivolumab. This treatment combines nivolumab, an immunotherapy drug, with a fluorescent dye, enabling doctors to observe how the drug spreads in the tumor during surgery. Participants will receive varying doses to determine the most effective one. Candidates for this trial include those with a high-grade glioma who are scheduled for surgery. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

The trial does not specify if you need to stop your current medications. However, if you are on chronic systemic immunosuppressive medication above a certain dose, you may not be eligible. It's best to discuss your specific medications with the trial team.

A previous study showed that nivolumab, the drug used in this trial, has side effects that patients with brain cancer could tolerate, suggesting it might be safe for humans. Nivolumab already has FDA approval for other conditions, indicating it is generally considered safe. However, this trial uses a special version called nivolumab-IRDye800, which includes a glowing dye to help doctors track the drug's movement in the tumor. Although this new version is being tested for the first time, early research suggests it is expected to have manageable side effects. This early phase trial primarily focuses on assessing safety.¹²³⁴⁵

Researchers are excited about Nivolumab-IRDye800 for brain cancer because it combines the immune-boosting effects of nivolumab with a fluorescent dye, IRDye800, that helps surgeons better visualize tumors during surgery. Unlike existing treatments like chemotherapy and radiation, which often have systemic effects, this approach targets the tumor more directly by enhancing surgical precision. This innovative method not only aims to improve surgical outcomes but also leverages nivolumab's potential to activate the immune system against cancer cells, offering a dual benefit in treatment.

Studies have shown that nivolumab can reach brain tumor areas and help the body's immune system fight cancer cells. This treatment, known as a checkpoint inhibitor, has shown promise in treating various cancers, though its success in brain cancer varies. Research indicates that nivolumab boosts the body's T-cells, which are crucial for attacking cancer cells. While its effectiveness for high-grade gliomas (an aggressive type of brain tumor) is still under investigation, early results suggest potential benefits. This trial tests a new version of nivolumab, Nivolumab-IRDye800, which includes a fluorescent dye to help doctors track the drug's spread in the tumor. Participants will receive different dosages of Nivolumab-IRDye800, either alone or with standard nivolumab, to determine the optimal dosing strategy.¹²⁴⁶⁷