Retifanlimab + DFMO for Brain Cancer

This trial explores a new combination of treatments for high-grade gliomas, an aggressive brain cancer that worsens despite previous treatments. The study examines the safety and effectiveness of retifanlimab, an immunotherapy drug, alone or with DFMO, which may inhibit cancer cell growth. Participants will receive these treatments before and after surgery. Individuals with worsening high-grade gliomas who plan to undergo surgery might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that retifanlimab, a type of immunotherapy, was safe in earlier studies. For instance, when combined with treatments like bevacizumab and radiotherapy, retifanlimab was safe and well-tolerated by patients with recurrent glioblastoma, a type of brain cancer.

Another study found that retifanlimab alone produced expected safety results in patients with various cancers, such as melanoma and lung cancer, indicating it is generally well-tolerated.

Regarding DFMO, when combined with retifanlimab, previous research suggests this pair could be safe for patients with high-grade glioma, a serious brain tumor. Although the current trial is still evaluating this combination, existing evidence is promising regarding its safety.

Researchers are excited about retifanlimab for brain cancer because it targets the PD-1/PD-L1 pathway, which is a different mechanism from standard chemotherapy or radiation treatments. This pathway is often used by cancer cells to evade the immune system, so blocking it can help the body recognize and attack the cancer. DFMO, combined with retifanlimab in some treatment arms, targets polyamine synthesis, which is crucial for cancer cell growth. This dual approach has the potential to be more effective than traditional treatments by not just attacking the cancer directly but also enhancing the body's immune response.

Research has shown that retifanlimab, a type of immune therapy, might enhance the body's ability to fight cancer cells. In studies, this drug has been combined with other treatments to manage recurrent glioblastoma, a type of brain cancer. On average, patients lived about 7.5 months without their cancer worsening. In this trial, participants in Group A and Group B2 will receive a combination of retifanlimab and DFMO, which aims to block a substance that aids cancer cell growth, potentially slowing or stopping tumor growth. Meanwhile, participants in Group B1 will receive retifanlimab alone before surgery. Although more research is needed, early results suggest these treatment approaches could be promising for aggressive brain tumors.¹²⁵⁶⁷