Drug combo aims to shrink NF2 tumors and save hearing

NCT ID NCT07708285

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

  • The First Hospital of Jilin University

    Changchun, Jilin, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053, China

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