NCT06470971 Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial
| NCT ID | NCT06470971 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yuanquan Yang |
| Condition | Advanced Malignant Solid Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Males or females aged ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Patients with any advanced cancer types who would benefit from anti-PD1 or anti-PD-L1 therapy rechallenge at the investigator's discretion * Patients must have had prior severe irAE while on ICI monotherapy or in combination with other anticancer treatment. Severe irAE is defined as any grade 2 or higher irAE requiring treatment discontinuation and prednisone \> 0.5 milligrams (mg)/kilogram (kg)/day (or equivalent) followed by a taper ≥ 4 weeks. Patients with history of grade 4 severe irAE need to carefully weigh the risks and benefits and might be eligible on a case-by-case basis after discussion with principal investigator (PI) * Recovery from prior irAEs to ≤ grade 1 * Patients who are on prednisone ≤ 10 mg/day (d) or equivalent are allowed * Hemoglobin \> 7 g/dL and \< 17 g/dL * Absolute neutrophil count (ANC) ≥ 1000 per mm\^3 * Platelet count ≥ 75 ×