Drug combo aims to shrink NF2 tumors and save hearing
NCT ID NCT07708285
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This trial tests whether combining two drugs—luvometinib (a targeted therapy) and serplulimab (an immunotherapy)—can shrink tumors and improve hearing in people with NF2-related schwannomatosis. Participants have progressive vestibular schwannomas or meningiomas that are not suitable for surgery. The study measures tumor response and hearing improvement, while monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of two drugs: luvometinib (a MEK inhibitor taken orally) and serplulimab (an immunotherapy given by IV infusion)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with NF2-related tumors that are not suitable for surgery, potentially preserving hearing and reducing tumor burden.
- What could go wrong
- This is an early-phase, small study (30 participants) with no control group, so results may not apply broadly. The combination may cause side effects from both drugs, and it is not yet known if it will work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must meet the diagnostic criteria for NF2-SWN. 2. 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. 3. The target tumor is considered unsuitable for surgery because of high risk. 4. Age \>=18 years at the time of screening. 5. KPS \>=70 or ECOG performance status 0 or 1. 6. Adequate organ function based on laboratory tests obtained within 14 days before screening. 7. Participant must be able to understand the study and voluntarily sign informed consent. Exclusion Criteria: 1. Pregnant, planning to become pregnant, or currently breastfeeding. 2. Participation in another interventional clinical trial within the past 4 weeks, or radiation therapy to target lesion(s) within the past 3 years. 3. Severe adverse reactions or intolerable toxicity from prior immune checkpoint inhibitors or MEK inhibitors. 4. Concomitant active malignancies, uncontrolled infections, or active autoimmune diseases. 5. Severe cardiac, hepatic, renal, gastrointestinal, or ophthalmic diseases. 6. Any other factor that may compromise participant safety or study integrity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
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Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
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Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
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The First Hospital of Jilin University
Changchun, Jilin, China
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
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