Luvometinib in Combination With Serplulimab for 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 Criteria: 1. Participants must meet the diagnostic criteria for NF2-SWN. 2. 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. 3. The target tumor is considered unsuitable for surgery because of high risk. 4. Age \>=18 years at the time of screening. 5. KPS \>=70 or ECOG performance status 0 or 1. 6. Adequate organ function based on laboratory tests obtained within 14 days before screening. 7. Participant must be able to understand the study and voluntarily sign informed consent. Exclusion Criteria: 1. Pregnant, planning to become pregnant, or currently breastfeeding. 2. Participation in another interventional clinical trial within the past 4 weeks, or radiation therapy to target lesion(s) within the past 3 years. 3. Severe adverse reactions or intolerable toxicity from prior immune checkpoint inhibitors or MEK inhibitors. 4. Concomitant active malignancies, uncontrolled infections, or active autoimmune diseases. 5. Severe cardiac, hepatic, renal, gastrointestinal, or ophthalmic diseases. 6. Any other factor that may compromise participant safety or study integrity.