Luvometinib in Combination With Serplulimab for NF2-Related Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Luvometinib
- Serplulimab
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov