Health TrialsbyHealthPanel

Luvometinib in Combination With Serplulimab for NF2-Related Tumors

ConditionsNF2-related SchwannomatosisNF2Neurofibromatosis Type 2Vestibular SchwannomaMeningioma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Luvometinib

    Drug

    Oral once daily per predetermined dosage per protocol.

  • Serplulimab

    Drug

    Intravenous infusion per predetermined dosage per protocol.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Luvometinib + SerplulimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) or Hearing Response Rate (HRR)

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.

Time frame
12 months

Secondary outcomes

1

Incidence of Adverse Events

Percentage of participants who experience at least one adverse event. Adverse events will be coded and graded according to NCI CTCAE v5.0.

Time frame
From first dose through 30 days after last dose (up to 12 months)
2

Maximum Severity Grade of Adverse Events

Maximum NCI CTCAE v5.0 grade of adverse events experienced by each participant during the reporting period.

Time frame
From first dose through 30 days after last dose (up to 12 months)
3

Incidence of Serious Adverse Events

Percentage of participants who experience at least one serious adverse event.

Time frame
From first dose through 30 days after last dose (up to 12 months)
4

Incidence of Dose Modifications

Percentage of participants who require at least one dose modification due to an adverse event.

Time frame
From first dose through 30 days after last dose (up to 12 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: