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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: Recruiting Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, sponsored by Yuanquan Yang.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events version (v) 5.0. irAEs are defined as AEs of immune nature (i.e., inflammatory) in the absence of a clear alternative etiology. The investigators will determine if an AE should be classified as irAE (yes/no). Will be defined as ≥ grade 2 requiring treatment discontinuation and prednisone \> 0.5 milligrams/kilogram/day or equivalent followed by a taper ≥ 4 weeks) within 24 weeks of ICI rechallenge.
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 |
What NCT06470971 shows while recruiting
NCT06470971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06470971's enrollment target sits among peer trials
40 61st of 108 higher than 45 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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