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Not yet recruiting NCT07708285

Luvometinib in Combination With Serplulimab for NF2-Related Tumors

Phase I / Phase II Interventional NF2-related Schwannomatosis NF2 Neurofibromatosis Type 2 Vestibular Schwannoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Luvometinib, Serplulimab.
Who it may be relevant to
Registry conditions: NF2-related Schwannomatosis, NF2, Neurofibromatosis Type 2, Vestibular Schwannoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter, Open-Label Study of Luvometinib in Combination With Serplulimab for the Treatment of NF2-Related Tumors

Overview

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.

Detailed description

NF2-related schwannomatosis (NF2-SWN) is a rare autosomal dominant disorder characterized by multiple central nervous system tumors, most commonly vestibular schwannomas and meningiomas. Although current treatments such as surgery and radiotherapy can provide disease control, they are not curative and are associated with cumulative neurological morbidity and potential risk of secondary malignancies. There remains a significant unmet need for effective systemic therapies.

This investigator-initiated study is conducted as a substudy within the Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2). The trial evaluates luvometinib in combination with serplulimab in patients with progressive NF2-SWN.

Luvometinib (FCN-159) is a selective MEK1/2 inhibitor with antitumor activity in NF1-associated tumors. Serplulimab (HLX10) is an anti-PD-1 monoclonal antibody approved for multiple solid tumors. Preclinical evidence suggests that MEK inhibition may enhance tumor immunogenicity and synergize with immune checkpoint blockade.

The study aims to assess the safety, tolerability, and preliminary efficacy of this combination in NF2-SWN.

Interventions

  • Drug Luvometinib
    Oral once daily per predetermined dosage per protocol.
  • Drug Serplulimab
    Intravenous infusion per predetermined dosage per protocol.

Primary outcome measures

  • Objective Response Rate (ORR) or Hearing Response Rate (HRR) [Time frame: 12 months]
Secondary outcome measures (6)
  • Incidence of Adverse Events [Time frame: From first dose through 30 days after last dose (up to 12 months)]
  • Maximum Severity Grade of Adverse Events [Time frame: From first dose through 30 days after last dose (up to 12 months)]
  • Incidence of Serious Adverse Events [Time frame: From first dose through 30 days after last dose (up to 12 months)]
  • Incidence of Dose Modifications [Time frame: From first dose through 30 days after last dose (up to 12 months)]
  • Incidence of Treatment Interruptions [Time frame: From first dose through 30 days after last dose.]
  • Incidence of Treatment Discontinuations [Time frame: From first dose through 30 days after last dose.]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Pregnant, planning to become pregnant, or currently breastfeeding.
  • 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.
  • Any other factor that may compromise participant safety or study integrity.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • Xuanwu Hospital, Capital Medical University — Beijing
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • Chinese PLA General Hospital — Beijing
  • The First Hospital of Jilin University — Changchun
  • Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT07708285 · HX-A-2026035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗