Luvometinib in Combination With Serplulimab for NF2-Related Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
Luvometinib: Oral once daily per predetermined dosage per protocol.
Serplulimab: Intravenous infusion per predetermined dosage per protocol.
Study summary
This is an investigator-initiated, exploratory, multicenter, open-label, single-arm clinical trial and a substudy of the Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2). The study aims to evaluate the safety, tolerability, and preliminary efficacy of luvometinib in combination with serplulimab in patients with NF2-related schwannomatosis (NF2-SWN) with progressive tumors.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) or Hearing Response Rate (HRR) — 12 months
Vestibular schwannoma: HRR is defined as WRS improvement exceeding the 95% critical difference from baseline; if baseline WRS is \<20%, HRR is defined as a PTA decrease of at least 10 dB. Meningioma: ORR is defined as at least a 20% reduction in target tumor volume from baseline.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | |
| The First Hospital of Jilin University | Changchun | Jilin | |
| Shanghai General Hospital | Shanghai | Shanghai Municipality |
More Beijing Tiantan Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07708285 on ClinicalTrials.gov ↗ ← All trials in China