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Prevention study for Advanced Malignant Solid Neoplasm
Official title Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial
ClinicalTrials.gov ID: NCT06470971
What this study is testing
What is Anti-PD-L1 Monoclonal Antibody?
Anti-PD-L1 Monoclonal Antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced malignant solid neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Recovery from prior irAEs to ≤ grade 1
You likely can't join if
- Women who are pregnant or breastfeeding
- Any ≥ grade 3 irAEs in which the risks outweigh the benefits per investigator's discretion (these may include but are not limited to myocarditis...
- Has active autoimmune disease or irAE requiring systemic treatment with steroids (\> 10 mg daily doses of prednisone or equivalent) or other...
- Cycle 1 day 1 of the study treatment must be at least 2 weeks beyond high dose systemic corticosteroids (prednisone \> 0.5 mg/kg/day or equivalent)...
- Other concurrent anticancer therapy except for palliative radiation and hormone therapy
- Has a known history of HIV-1/2 with detectable viral load and/or CD4 (cluster of differentiation 4) count \< 300/mL within the previous 3 months
See the full eligibility 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...
- 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 × 10\^9/L
- Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN or ≤ 5 × ULN for patients with liver...
- Measured or calculated creatinine clearance (CL) ≥ 30 mL/min except patients with end-stage renal disease on hemodialysis
- Cycle 1 day 1 of the study treatment should be at least 2 weeks since prior systemic therapy, radiotherapy, or surgery
- Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks
- people of childbearing potential must have a negative serum pregnancy test at screening
- people of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing informed consent and for the...
- Childbearing potential is defined by the following criteria: 1. Subject has not undergone a hysterectomy or bilateral oophorectomy; or 2. has not been naturally postmenopausal for at least 12 consecutive months (i.e...
- Highly effective birth control methods (less than 1% failure rate per year if used consistently and correctly) include but are not limited to: 1. Oral, injected, or implanted hormonal method of contraception; 2. Place...
- people must not breastfeed a child during the study and for 3 months after the last dose of study drug
- Ability to understand and willingness to sign the written informed consent document
- Women who are pregnant or breastfeeding
- Any ≥ grade 3 irAEs in which the risks outweigh the benefits per investigator's discretion (these may include but are not limited to myocarditis, myasthenia gravis, Guillain-Barré syndrome, encephalitis, myelitis, or...
- Has active autoimmune disease or irAE requiring systemic treatment with steroids (\> 10 mg daily doses of prednisone or equivalent) or other immunosuppressive agents or any condition that, in the investigator's...
- Cycle 1 day 1 of the study treatment must be at least 2 weeks beyond high dose systemic corticosteroids (prednisone \> 0.5 mg/kg/day or equivalent); chronic steroid use up to 10 mg daily prednisone (or equivalent) is...
- Other concurrent anticancer therapy except for palliative radiation and hormone therapy
- Has a known history of HIV-1/2 with detectable viral load and/or CD4 (cluster of differentiation 4) count \< 300/mL within the previous 3 months
- Has detectable hepatitis B virus (HBV) or hepatitis C virus (HCV) viral load polymerase chain reaction (PCR) if there is a known history of active hepatitis B or hepatitis C
- High risk for bowel perforation per the investigator's judgment, such as history of severe diverticulitis or active ulcers or extensive gastrointestinal (GI) involvement by the tumor
- Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or an allogeneic peripheral blood stem...
- Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, myocardial infarction within 1 month...
- Patients with a current severe infection
- Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients
- Prior failure of interleukin-6 or interleukin-6 receptor targeted therapies. Prior IL-6 or IL-6 receptor-targeted therapies are permitted if the response was favorable
- Received any investigational drug within 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.