Study on Siltuximab to Prevent Severe Side Effects During Immune Therapy Restart in Patients with Advanced Cancer

Sponsor: Yuanquan Yang

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06470971

Provider View

This clinical trial is testing whether the drug siltuximab can help prevent severe side effects when restarting immune checkpoint inhibitor therapy in patients with advanced cancer. These side effects can occur when the immune system attacks healthy organs, and siltuximab may help reduce this risk.

Patient Parameters

Program Overview

This study is exploring if siltuximab can prevent severe immune-related side effects when patients with advanced cancer restart immune checkpoint inhibitor (ICI) therapy. ICIs help the immune system fight cancer but can sometimes cause the immune system to attack healthy organs, leading to severe side effects. Siltuximab is a drug that may help lower the immune response and reduce inflammation, potentially preventing these side effects during ICI therapy restart.

Description

The main goal of this study is to see if siltuximab can reduce the occurrence of new or returning severe side effects within 24 weeks of restarting immune therapy. Researchers will also look at how well the treatment works against cancer, including response rates and survival times.

Participants will receive immune therapy (anti-PD1 or anti-PD-L1) every 2 to 6 weeks, along with siltuximab given through an IV on the first day of each cycle. The treatment will continue for up to 8 doses over 3 weeks or 6 doses over 4 weeks, unless the cancer progresses or side effects become too severe.

Patients may have biopsies, bone scans, blood tests, and imaging scans during the study. After treatment, follow-ups will occur at 28 days, every 12 weeks for 2 years, and then every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Good general health with a performance status of 0, 1, or 2.
  • Have advanced cancer that could benefit from restarting immune therapy.
  • Previously experienced severe side effects from immune therapy, requiring treatment to stop and use of steroids.
  • Recovered from previous side effects to mild levels.
  • Currently taking 10 mg or less of prednisone daily.
  • Meet specific blood count and organ function requirements.
  • At least 2 weeks since last cancer treatment.
  • Expected to live at least 12 more weeks.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Must not breastfeed during the study and for 3 months after.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Severe side effects from previous immune therapy that outweigh potential benefits.
  • Active autoimmune disease or need for high-dose steroids.
  • Recent use of high-dose steroids or other cancer treatments.
  • Active infections like HIV or hepatitis with detectable viral load.
  • High risk for bowel issues or have had organ transplants.
  • Uncontrolled health conditions like heart failure or severe infections.
  • Allergies to study drugs or similar medications.
  • Previous failure with IL-6 targeted therapies unless response was favorable.
  • Recent use of investigational drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.