Sarilumab + ICI Therapy for Solid Tumors

(IRIS Trial)

This trial tests a combination of two treatments, Sarilumab and immune checkpoint inhibitors (ICI), for individuals who have had cancer and experienced significant side effects from ICI therapy. The goal is to determine if this new approach can manage these side effects and enable patients to continue their cancer treatment. Suitable candidates for this trial have previously used ICI for cancer and experienced side effects, such as arthritis or lung inflammation, that improved after stopping the treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Research has shown that sarilumab, when combined with immune checkpoint inhibitors (ICIs), is generally safe. ICIs help the immune system fight cancer but can sometimes cause side effects where the immune system attacks healthy cells. Sarilumab helps manage these side effects and has proven effective and safe.

Many patients using ICIs experience immune-related side effects. Adding sarilumab to the treatment plan aims to reduce these side effects, and studies suggest this combination is usually well-tolerated. Specifically, participants in those studies reported fewer severe side effects when sarilumab was included.

Researchers are excited about the combination of Sarilumab with immune checkpoint inhibitor (ICI) therapy for solid tumors because it brings a novel approach to treatment. Unlike standard ICI therapies that solely target immune checkpoints to boost the immune system against cancer cells, Sarilumab is an anti-inflammatory drug that blocks the interleukin-6 (IL-6) receptor. This dual approach aims to enhance the effectiveness of ICIs by potentially reducing inflammation-related resistance, offering hope for improved outcomes in treating solid tumors.

Research has shown that immune checkpoint inhibitors (ICIs) can effectively treat solid tumors. One study found that 78% of patients did not experience cancer growth for at least one year after treatment, and 93% were still alive one year after starting treatment. In this trial, participants will receive a combination of ICIs with sarilumab. Combining ICIs with other treatments, such as sarilumab, has shown promise in improving these results by potentially enhancing the body's immune response against cancer. Although sarilumab is typically used for arthritis, it may help manage the immune-related side effects of ICIs, making it a potential partner in cancer treatment.⁶⁷⁸⁹¹⁰