RP1 + Nivolumab for Cancer

(IGNYTE Trial)

This trial explores a new cancer treatment using two drugs: RP1 (vusolimogene oderparepvec, an experimental treatment) and nivolumab (also known as Opdivo, an immunotherapy drug), to evaluate their combined effectiveness. It targets individuals with advanced solid tumors unresponsive to other treatments. The trial aims to determine the optimal dose and assess its efficacy. This trial may suit those with hard-to-treat cancers like melanoma or non-melanoma skin cancer, particularly if previous treatments have failed. Participants should have at least one tumor that can be measured and treated directly. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic anti-viral medications, you may not be eligible to participate.

Research has shown that RP1 specifically targets and infects cancer cells, leaving healthy cells unharmed. In one study, 89.4% of patients with surface-level tumors experienced some side effects from the treatment, but these were typical for cancer therapies. Previous research indicates that RP1 can fight tumors even if they are not directly treated with the drug.

Nivolumab, another part of this trial, has been safely used in various types of cancer. As an approved treatment, extensive information exists about its safety. Most side effects are known and can be managed.

Researchers are excited about the combination of RP1 and nivolumab for cancer treatment because it offers a unique approach compared to current options. Unlike traditional therapies that often rely solely on immune checkpoint inhibitors like nivolumab, this treatment includes RP1, a genetically modified virus that directly targets and destroys cancer cells while also boosting the immune system's response. This dual action not only helps shrink tumors but also enhances the effectiveness of nivolumab. Additionally, RP1 is administered directly into the tumor, potentially leading to more targeted and efficient treatment. This innovative strategy could provide new hope for patients who have not responded to standard therapies.

Studies have shown that RP1, an improved viral therapy, can work well with nivolumab to treat certain skin cancers. In this trial, participants with melanoma who did not respond to previous treatments will receive the combination of RP1 and nivolumab, which led to significant and lasting improvements in past studies. Specifically, about 31.4% of patients experienced a noticeable reduction in their tumors, and 12.2% saw their tumors disappear completely. Nivolumab alone has a strong history of treating skin cancers like melanoma and lung cancer, providing long-term survival benefits. The combination of RP1 and nivolumab is promising because it helps the body's immune system attack cancer cells. This approach could offer new hope for those whose cancers didn't respond to other treatments.⁶⁷⁸⁹¹⁰