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Study identifier: NCT06470971 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial

Condition: Advanced Malignant Solid Neoplasm · Hematopoietic and Lymphatic System Neoplasm  ·  Sponsor: Yuanquan Yang

PhasePhase 2
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase II trial studies how well giving siltuximab during the reintroduction (rechallenge) of immune checkpoint inhibitor (ICI) therapy works in preventing severe immune-related adverse events (irAEs) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immune checkpoint inhibitors, such as anti-PD1 and anti-PD-L1 monoclonal antibodies, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The use of ICI therapy may lead to severe irAEs that can affect essentially any organ system in the body. Severe irAEs may lead to the early stopping of life saving treatment. Most patients that stop ICI therapy early will eventually progress and require additional treatment. Sometimes the decision is made to rechallenge with ICI therapy. Many patients who developed severe irAEs during initial ICI therapy are at risk for developing severe irAEs again during the rechallenge. Siltuximab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6). This may help lower the body's immune response and reduce inflammation. Giving siltuximab during ICI rechallenge may help prevent severe irAEs in patients with advanced cancer.

This description comes directly from the study's public registry record.

Talk to the study team

The Ohio State University Comprehensive Cancer Cener  ·  800-293-5066  ·  OSUCCCClinicaltrials@osumc.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06470971