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Study details
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Siltuximab for Preventing Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge

Yuanquan Yang
NCT IDNCT06470971ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

40

Study length

about 6.5 years

Ages

18+

Locations

1 site in OH

About this study

This trial is testing if giving siltuximab during the reintroduction of immune checkpoint inhibitor (ICI) therapy can prevent severe immune-related adverse events (irAEs) in patients with advanced cancer. ICI therapy may cause severe irAEs that can affect many organs, potentially leading to stopping treatment early and progression. Siltuximab is a monoclonal antibody that may help reduce inflammation and prevent these severe irAEs during the rechallenge.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Quality-of-Life Assessment
  • 2.Receive Anti-PD-L1 Monoclonal Antibody
  • 3.Receive Anti-PD1 Monoclonal Antibody
  • +3 more
PhasePhase 2
DrugSiltuximab
Routeinjection
Primary goalIncidence of severe immune-related adverse event (irAE)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low15%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

siltuximab

Drug routes

injection (Injection)

Endpoints

Primary: Incidence of severe immune-related adverse event (irAE)

Secondary: Median progression-free survival, Overall response rate, Overall survival

Procedures

biopsy, diagnostic, imaging