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

NCT07713745 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-20

No results posted yet for this study

Summary

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

Conditions

  • NF2
  • Neurofibromatosis Type 2
  • Vestibular Schwannoma
  • Non-vestibular Schwannoma
  • Meningioma
  • Ependymoma
  • NF2-related Schwannomatosis

Interventions

DRUG

Selumetinib 25mg/m2

Oral twice daily per predetermined dosage per protocol.

DRUG

Luvometinib

Oral once daily per predetermined dosage per protocol.

DRUG

Serplulimab

Intravenous infusion per predetermined dosage per protocol.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-18
Primary Completion
2036-06-01
Completion
2036-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07713745 on ClinicalTrials.gov