Clinical trial · Interventional
Luvometinib in Combination With Serplulimab for NF2-Related Tumors
A Multicenter, Open-Label Study of Luvometinib in Combination With Serplulimab for the Treatment of NF2-Related Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Neurofibromatosis Type 2 | — | UNRESOLVED | — |
| NF2 | — | UNRESOLVED | — |
| NF2-related Schwannomatosis | — | UNRESOLVED | — |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luvometinib | Drug | — | UNRESOLVED |
| Serplulimab | Drug | Serplulimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Luvometinib + Serplulimab
- description
- Subjects will receive luvometinib 8 mg by mouth once daily in combination with serplulimab 4.5 mg/kg intravenously every 3 weeks for up to 12 cycles (28 days per cycle).
- interventionNames
- Drug: Luvometinib
- Drug: Serplulimab
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) or Hearing Response Rate (HRR)
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available