Luvometinib in Combination With Serplulimab for NF2-Related Tumors
Key facts
- Phase
- Phase 1/2
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT07708285
- Record updated
- 16 July 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Open-Label Study of Luvometinib in Combination With Serplulimab for the Treatment of NF2-Related Tumors
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.
Inclusion: Participants must meet the diagnostic criteria for NF2-SWN; Presence of at least one measurable target tumor, either vestibular schwannoma or meningioma, with MRI-documented volumetric progression within the past 36 months or clinical symptom progression related to the target tumor; The target tumor is considered unsuitable for surgery because of high risk; Age >=18 years at the time of screening; KPS >=70 or ECOG performance status 0 or 1; Adequate organ function based on laboratory tests obtained within 14 days before screening; Participant must be able to understand the study and voluntarily sign informed consent.
Exclusion: Participation in another interventional clinical trial within the past 4 weeks, or radiation therapy to target lesion(s) within the past 3 years; Severe adverse reactions or intolerable toxicity from prior immune checkpoint inhibitors or MEK inhibitors; Concomitant active malignancies, uncontrolled infections, or active autoimmune diseases; Severe cardiac, hepatic, renal, gastrointestinal, or ophthalmic diseases; Pregnant, planning to become pregnant, or currently breastfeeding; Any other factor that may compromise participant safety or study integrity.