NF2

4

Review clinical trials related to NF2. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)

This is an adaptive platform-basket trial that aims to evaluate the safety and efficacy of multiple novel agents and combination therapies in patients with NF2-related schwannomatosis (NF2-SWN). The study employs a basket design to assess treatment responses across four tumor types commonly associated with NF2-SWN: vestibular schwannomas, non-vestibular schwannomas, meningiomas, and ependymomas. A shared natural history observational cohort, receiving routine clinical follow-up without investigational treatment, serves as a common control for all substudies. The adaptive platform enables the dynamic addition or closure of substudies based on interim analyses, thereby optimizing trial efficiency. Eligible patients who meet the master protocol criteria and satisfy substudy-specific safety requirements will be assigned to receive the corresponding intervention. Currently open substudies include: * Substudy A: Selumetinib * Substudy B: Luvometinib plus Serplulimab

Participants needed: 200
Trial details
Phase: Phase 2Biological sex: AllType: InterventionalSponsor: Beijing Tiantan HospitalUpdated: Jul 20, 2026Locations: 5
Eligibility criteria

Bilateral vestibular schwannomas (VS) [+7]

Coexisting other genetic syndromes that may cause multiple intracranial tumors (... [+4]

Status: Not yet recruiting

Selumetinib for NF2-Related Schwannomatosis

The goal of this clinical trial is to evaluate the efficacy and safety of the MEK1/2 inhibitor selumetinib in treating patients with neurofibromatosis type 2-related schwannomatosis (NF2-SWN), including both adults and children with inoperable or progressive tumors.

Participants needed: 20
Trial details
Phase: Phase 2Age: 3+Biological sex: AllType: InterventionalSponsor: Beijing Tiantan HospitalUpdated: Jul 16, 2026Locations: 1
Eligibility criteria

Bilateral vestibular schwannomas, OR [+44]

Concurrent involvement in study conduct:the subject is an employee of the Sponso... [+20]

Status: Not yet recruiting

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.

Participants needed: 30
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Beijing Tiantan HospitalUpdated: Jul 16, 2026Locations: 5
Eligibility criteria

Participants must meet the diagnostic criteria for NF2-SWN. [+6]

Pregnant, planning to become pregnant, or currently breastfeeding. [+5]

Status: Not yet recruiting

Study to Determine Optimal Dose, Evaluate the Efficacy and Safety of PRG-N-01 in Patients With Neurofibromatosis Type II

The goal of this clinical trial is to learn if Trineumin(Code name:PRG-N-01) works to treat Neurofibromatosis Type II(NF2) in adults. It will also learn about the safety and tolerability and toxicity of PRG-N-01. The main questions it aims to answer are: * What dose was determined as the Maximum Tolerated Dose (MTD) of Trineumin? * What dose was explored as the optimal effective dose of Trineumin based on radiographic response? * Does Trineumin reduce tumor size or improve participants' quality of life, including hearing function? * What medical problems do participants have when taking Trineumin? Participants will: * Take Trineumin every day for 96 weeks * Visit the clinic once 1, 4, 8, 12, 18week and every 12 weeks and for checkups and tests

Participants needed: 25
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: PRG Science & Technology Co., Ltd.Updated: Jan 23, 2026
Eligibility criteria

Male or female subjects aged 18 years or older at screening [+2]

Uncontrolled hypertension at screening (DBP ≥100 mmHg or SBP ≥160 mmHg despite t... [+12]