OncoMatch/Clinical Trials/NCT05684692
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
Is NCT05684692 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Siltuximab and Erenumab-Aooe for schwannomatosis.
Treatment: Siltuximab · Erenumab-Aooe — This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: * Investigational Drug Sub-Study A: Siltuximab * Investigation Drug Sub-Study B: Erenumab-Aooe
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: SMARCB1 pathogenic mutation
one pathologically proven schwannoma or meningioma and a germline SMARCB1 or LZTR1 pathogenic mutation
Required: LZTR1 pathogenic mutation
one pathologically proven schwannoma or meningioma and a germline SMARCB1 or LZTR1 pathogenic mutation
Required: NF2 two different mutations with LOH for chromosome 22 in at least two tumors
genetic studies of at least two tumors with loss of heterozygosity (LOH) for chromosome 22 and two different NF2 mutations
Prior therapy
Cannot have received: chemotherapy
Participants who have had chemotherapy within a minimum of 4 weeks prior to Master Study registration (or a minimum of 5 half-lives and resolution to baseline of toxicities unless there are irreversible toxicities from prior drug that do not influence risk of next drug).
Cannot have received: investigational agent
Participants who are receiving any other investigational agents.
Cannot have received: investigational product
Treatment with any investigational products within 1 month or 5 half-lives (whichever is longer) before the first dose of study drug
Lab requirements
Blood counts
Serum lipase ≤1.5 × institutional ULN; Absolute neutrophil count ≥1.5 × 10^9/L; Platelet count ≥75 × 10^9/L; Hemoglobin ≥9 g/dL and <17 g/dL
Kidney function
Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) equation
Liver function
ALT/aspartate aminotransferase (AST) ≤ 2.5 × institutional upper limit of normal (ULN); Total serum bilirubin ≤ 1.5 × institutional ULN (<3.0 × institutional ULN for patients with Gilbert syndrome)
Clinical laboratory values as specified below within 28 days before the first dose of study drug: ALT/aspartate aminotransferase (AST) ≤ 2.5 × institutional upper limit of normal (ULN); Total serum bilirubin ≤ 1.5 × institutional ULN (<3.0 × institutional ULN for patients with Gilbert syndrome) Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) equation Serum lipase ≤1.5 × institutional ULN Absolute neutrophil count ≥1.5 × 10^9/L Platelet count ≥75 × 10^9/L Hemoglobin ≥9 g/dL and <17 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
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