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NCT06470971 · ClinicalTrials.gov registry record · Phase 2
Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial
A Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, sponsored by Yuanquan Yang.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06470971 is a Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm that is actively recruiting participants, run by Yuanquan Yang. The registered enrollment target is 40 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06470971, a Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, is actively recruiting participants, sponsored by Yuanquan Yang.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- PROCEDURE Bone Scan
- BIOLOGICAL Anti-PD-L1 Monoclonal Antibody
- BIOLOGICAL Anti-PD1 Monoclonal Antibody
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-09 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06470971
The ClinicalTrials.gov registry entry for NCT06470971 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower). The listed sponsor is Yuanquan Yang, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06470971 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06470971 about?
NCT06470971 is a clinical study titled "Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial". 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, lymp...
What is the current status of trial NCT06470971?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-07-09. Estimated completion is 2030-12-31.
What conditions does trial NCT06470971 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm.
What interventions are being tested in trial NCT06470971?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Bone Scan (PROCEDURE), Anti-PD-L1 Monoclonal Antibody (BIOLOGICAL), Anti-PD1 Monoclonal Antibody (BIOLOGICAL).
Who is sponsoring clinical trial NCT06470971?
This trial is sponsored by Yuanquan Yang, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06470971 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.