Neurofibromatosis Type 2Phase 2PRIME-NF2NCT07713745
Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)
A Phase 2 study testing Selumetinib 25mg/m2, Luvometinib and Serplulimab in people with Neurofibromatosis Type 2 and Vestibular Schwannoma, run by Beijing Tiantan Hospital at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma
- What is being tested?
- Selumetinib 25mg/m2, Luvometinib and Serplulimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 18 Jul 2026to 31 Dec 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must satisfy all of the following criteria to be enrolled into the main study natural history observation cohort:
- Must meet the 2022 International Consensus Criteria for NF2-SWN, defined by having at least one of the following:
- Bilateral vestibular schwannomas (VS)
- An identical NF2 pathogenic variant in at least 2 anatomically distinct NF2-related tumors (schwannoma, meningioma, and/or ependymoma). (Note: if the variant allele fraction (VAF) in unaffected tissues such as blood is clearly <50%, the diagnosis is mosaic NF2-related schwannomatosis)
- Either 2 major or 1 major and 2 minor criteria as described in the following:
- Major criteria:
Show all 15Show fewer
- Unilateral VS
- First-degree relative other than sibling with NF2-related schwannomatosis
- 2 or more meningiomas (Note: single meningioma qualifies as minor criteria).
- NF2 pathogenic variant in an unaffected tissue such as blood (Note: if the VAF is clearly <50%, the diagnosis is mosaic NF2-related schwannomatosis)
- Minor criteria:
- Can count >1 of a type (eg, 2 distinct schwannomas would count as 2 minor criteria)
- Ependymoma, meningioma (Note: multiple meningiomas qualify as a major criteria), schwannoma (Note: if the major criterion is unilateral VS, at least 1 schwannoma must be dermal in location) Can count only once (eg, bilateral cortical cataracts count as a single minor criterion)
- Juvenile subcapsular or cortical cataract, retinal hamartoma, epiretinal membrane in a person aged <40 years, meningioma
- Presence of at least one evaluable lesion: Vestibular schwannoma, meningioma, or non-vestibular schwannoma: clearly identifiable lesion on contrast-enhanced T1-weighted MRI; Ependymoma: clearly identifiable lesion on contrast-enhanced T1-weighted or T2/FLAIR sequences; (3) Expected ability to complete at least 12 months of follow-up assessments; (4) Ability to understand and voluntarily sign a written informed consent form, or a legally authorized guardian signs the informed consent form together ; (5) Sub-study-specific criteria (for intervention arms only): If the subject intends to enter an interventional sub-study, in addition to meeting the above main study criteria, the subject must also satisfy the specific inclusion criteria specified in that sub-study protocol (e.g., organ function, prior treatment restrictions, washout periods, etc.), as determined by the drug characteristics.
Who cannot join
- Subjects meeting any of the following criteria will not be permitted to enter the main study:
- Coexisting other genetic syndromes that may cause multiple intracranial tumors (e.g., SMARCB1/LZTR1-related schwannomatosis, Cowden syndrome);
- Expected survival <12 months;
- Presence of severe psychiatric disorders or cognitive impairment that precludes cooperation with imaging or hearing assessments;
- Extreme social or geographic factors that, in the investigator's judgment, may impede follow-up for more than 12 months;
- Sub-study-specific exclusion criteria (for intervention arms only): If the subject intends to enter an interventional sub-study, the subject must also satisfy the specific exclusion criteria specified in that sub-study protocol (e.g., specific organ dysfunction, active infection, pregnancy, etc.).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Hao Wu, PhD, +86 10-83922345, wuhaospine@xwh.ccmu.edu.cn
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Pinan Liu, PhD, 86+ 10-59976611, pinanliu@ccmu.edu.cn
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jun Zhang, PhD, 86+ 10-68182255, junzhang301@163.com
The First Hospital of Jilin University
Changchun, Jilin, 130021
Yunqian Li, PhD, 86+ 431-88782222, yunqian@jlu.edu.cn
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Meiqing Lou, PhD, +86 21-63846590, loumq68128@hotmail.com
About this study
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.
Read more
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
Read the detailed description
This is an investigator-initiated, prospective, multicenter, adaptive platform-basket clinical trial designed to evaluate the safety and efficacy of multiple therapies in patients with NF2-related schwannomatosis (NF2-SWN). The study includes four tumor baskets: vestibular schwannoma, meningioma, non-vestibular schwannoma, and ependymoma.
MASTER STUDY All patients with a confirmed diagnosis of NF2-SWN who provide written informed consent will be enrolled in the master study and enter the natural history observational cohort. Patients who meet eligibility criteria for one or more active substudies may be assigned to a corresponding treatment arm. When multiple treatment arms are open, allocation will follow a predefined randomization scheme. When only one treatment arm is available, eligible patients may be enrolled directly into that substudy. Patients not eligible for any active intervention will remain in the master study cohort for standardized follow-up.
Patients who experience progression of the target tumor during substudy treatment may be considered for enrollment into another active treatment arm if eligibility criteria are met. Patients who are not eligible for any active substudy will return to the master study observational cohort. Data collected during follow-up may serve as shared control data across the platform.
Patients in the observational cohort will undergo standardized follow-up assessments every 12 months until study completion or voluntary withdrawal. Patients receiving treatment within a substudy will undergo efficacy and safety assessments approximately every 3 months according to the corresponding substudy protocol. The master study plans to enroll at least 200 patients with NF2-SWN, with enrollment continuing over time as eligible patients are identified across participating centers.
SUBSTUDY 1: Selumetinib
- Selumetinib is a selective MEK1/2 inhibitor approved for the treatment of NF1-associated plexiform neurofibromas. It inhibits tumor growth through blockade of the RAS/RAF/MEK/ERK signaling pathway.
- This substudy plans to enroll 20 patients, prioritizing those with vestibular schwannoma as the target tumor. Detailed eligibility criteria are provided in the substudy protocol.
SUBSTUDY 2: Luvometinib + Serplulimab
- Luvometinib is a selective oral MEK1/2 inhibitor. Serplulimab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1 signaling and restores T-cell-mediated antitumor immune activity by preventing interaction with PD-L1 and PD-L2.
- This substudy plans to enroll approximately 30 adult patients, prioritizing those with vestibular schwannoma or meningioma as the target tumor. Detailed inclusion and exclusion criteria are described in the substudy protocol.
Each substudy protocol will be incorporated into the master protocol as an appendix. Addition of new substudies requires review and approval by the Data and Safety Monitoring Board (DSMB).
Efficacy will be evaluated using tumor-specific endpoints. For vestibular schwannoma, the primary endpoint is Hearing Response Rate (HRR). For meningioma, non-vestibular schwannoma, and ependymoma, the primary endpoint is radiographic Objective Response Rate (ORR). All efficacy endpoints will undergo blinded central review by an Independent Review Committee (IRC).
The platform is expected to remain active for 5-10 years, or until all active substudies are completed and no additional treatment arms are planned.
- Conditions
- Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, Ependymoma, NF2-related Schwannomatosis
- Being tested
- Selumetinib 25mg/m2, Luvometinib, Serplulimab
- Medical subject headings
- Neurofibromatosis 2, Neuroma, Acoustic, Meningioma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selumetinib 25mg/m2Drug
Also called Koselugo, AZD6244
Oral twice daily per predetermined dosage per protocol.
LuvometinibDrug
Also called FCN-159
Oral once daily per predetermined dosage per protocol.
SerplulimabDrug
Also called HLX10
Intravenous infusion per predetermined dosage per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Substudy A (Selumetinib) | Experimental | Subjects will receive selumetinib 25 mg/m² by mouth twice daily (single dose not to exceed 50 mg) for up to 12 cycles (28 days per cycle). Receives: Drug: Selumetinib 25mg/m2 |
| Substudy B (Luvometinib + Serplulimab) | Experimental | Subjects will receive luvometinib 8 mg by mouth once daily in combination with serplulimab 4.5 mg/kg intravenously every 3 weeks for up to 12 cycles (28 days per cycle). Receives: Drug: Luvometinib; Drug: Serplulimab |
| Natural History Cohort | No intervention | Participants who are not eligible for any active treatment substudy, or who choose not to receive investigational therapy, will remain in the Natural History Observation Arm. No study intervention will be administered. Participants will undergo standardized longitudinal clinical, imaging, and outcome assessments according to the master protocol. Data collected from this arm will be used to characterize the natural history of NF2-related schwannomatosis and will serve as a shared observational comparator for active treatment arms within the platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-Type-Specific Response Rate in NF2-SWN Tumors
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 or non-vestibular schwannoma: ORR is defined as at least a 20% reduction in target tumor volume from baseline.
Ependymoma: ORR is defined as at least a 30% reduction in maximum diameter from baseline according to RECIST v1.1.
Measured: 12 months
Secondary outcomes (6)
Incidence of Adverse Events in Interventional Substudies
Percentage of participants receiving active treatment who experience at least one adverse event. Adverse events will be coded and graded according to NCI CTCAE v5.0.
Measured: From first dose through 30 days after last dose (or as specified by individual substudy protocols)
Maximum Severity Grade of Adverse Events in Interventional Substudies
Maximum NCI CTCAE v5.0 grade of adverse events experienced by each participant during the reporting period.
Measured: 12 months
Incidence of Serious Adverse Events in Interventional Substudies
Percentage of participants receiving active treatment who experience at least one serious adverse event.
Measured: From first dose through 30 days after last dose.
Incidence of Dose Modifications Due to Adverse Events
Percentage of participants receiving active treatment who require at least one dose modification due to an adverse event.
Measured: From first dose through 30 days after last dose.
Incidence of Treatment Interruptions Due to Adverse Events
Percentage of participants receiving active treatment who require at least one treatment interruption due to an adverse event.
Measured: From first dose through 30 days after last dose.
Incidence of Treatment Discontinuations Due to Adverse Events
Percentage of participants receiving active treatment who discontinue treatment due to an adverse event.
Measured: From first dose through 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start18 Jul 2026 (estimated)
- Primary completion1 Jun 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 2Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713745
- Sponsor's protocol ID
- HX-A-2026016
- Acronym
- PRIME-NF2
- Status last verified
- May 2026
- First submitted
- 3 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)
- ClinicalTrials.gov ID
- NCT07713745
- Acronym / sponsor ID
- PRIME-NF2 / HX-A-2026016
- Conditions
- Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, Ependymoma, NF2-related Schwannomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 18 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an investigator-initiated, prospective, multicenter, adaptive platform-basket clinical trial designed to evaluate the safety and efficacy of multiple therapies in patients with NF2-related schwannomatosis (NF2-SWN). The study includes four tumor baskets: vestibular schwannoma, meningioma, non-vestibular schwannoma, and ependymoma.
MASTER STUDY All patients with a confirmed diagnosis of NF2-SWN who provide written informed consent will be enrolled in the master study and enter the natural history observational cohort. Patients who meet eligibility criteria for one or more active substudies may be assigned to a corresponding treatment arm. When multiple treatment arms are open, allocation will follow a predefined randomization scheme. When only one treatment arm is available, eligible patients may be enrolled directly into that substudy. Patients not eligible for any active intervention will remain in the master study cohort for standardized follow-up.
Patients who experience progression of the target tumor during substudy treatment may be considered for enrollment into another active treatment arm if eligibility criteria are met. Patients who are not eligible for any active substudy will return to the master study observational cohort. Data collected during follow-up may serve as shared control data across the platform.
Patients in the observational cohort will undergo standardized follow-up assessments every 12 months until study completion or voluntary withdrawal. Patients receiving treatment within a substudy will undergo efficacy and safety assessments approximately every 3 months according to the corresponding substudy protocol. The master study plans to enroll at least 200 patients with NF2-SWN, with enrollment continuing over time as eligible patients are identified across participating centers.
SUBSTUDY 1: Selumetinib
- Selumetinib is a selective MEK1/2 inhibitor approved for the treatment of NF1-associated plexiform neurofibromas. It inhibits tumor growth through blockade of the RAS/RAF/MEK/ERK signaling pathway.
- This substudy plans to enroll 20 patients, prioritizing those with vestibular schwannoma as the target tumor. Detailed eligibility criteria are provided in the substudy protocol.
SUBSTUDY 2: Luvometinib + Serplulimab
- Luvometinib is a selective oral MEK1/2 inhibitor. Serplulimab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1 signaling and restores T-cell-mediated antitumor immune activity by preventing interaction with PD-L1 and PD-L2.
- This substudy plans to enroll approximately 30 adult patients, prioritizing those with vestibular schwannoma or meningioma as the target tumor. Detailed inclusion and exclusion criteria are described in the substudy protocol.
Each substudy protocol will be incorporated into the master protocol as an appendix. Addition of new substudies requires review and approval by the Data and Safety Monitoring Board (DSMB).
Efficacy will be evaluated using tumor-specific endpoints. For vestibular schwannoma, the primary endpoint is Hearing Response Rate (HRR). For meningioma, non-vestibular schwannoma, and ependymoma, the primary endpoint is radiographic Objective Response Rate (ORR). All efficacy endpoints will undergo blinded central review by an Independent Review Committee (IRC).
The platform is expected to remain active for 5-10 years, or until all active substudies are completed and no additional treatment arms are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Substudy A (Selumetinib) | Experimental | Drug: Selumetinib 25mg/m2Subjects will receive selumetinib 25 mg/m² by mouth twice daily (single dose not to exceed 50 mg) for up to 12 cycles (28 days per cycle). |
| Substudy B (Luvometinib + Serplulimab) | Experimental | Drug: Luvometinib, Drug: SerplulimabSubjects will receive luvometinib 8 mg by mouth once daily in combination with serplulimab 4.5 mg/kg intravenously every 3 weeks for up to 12 cycles (28 days per cycle). |
| Natural History Cohort | No intervention | –Participants who are not eligible for any active treatment substudy, or who choose not to receive investigational therapy, will remain in the Natural History Observation Arm. No study intervention will be administered. Participants will undergo standardized longitudinal clinical, imaging, and outcome assessments according to the master protocol. Data collected from this arm will be used to characterize the natural history of NF2-related schwannomatosis and will serve as a shared observational comparator for active treatment arms within the platform. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must satisfy all of the following criteria to be enrolled into the main study natural history observation cohort:
- Must meet the 2022 International Consensus Criteria for NF2-SWN, defined by having at least one of the following:
- Bilateral vestibular schwannomas (VS)
- An identical NF2 pathogenic variant in at least 2 anatomically distinct NF2-related tumors (schwannoma, meningioma, and/or ependymoma). (Note: if the variant allele fraction (VAF) in unaffected tissues such as blood is clearly <50%, the diagnosis is mosaic NF2-related schwannomatosis)
- Either 2 major or 1 major and 2 minor criteria as described in the following:
Key exclusion criteria (6 listed)
- Subjects meeting any of the following criteria will not be permitted to enter the main study:
- Coexisting other genetic syndromes that may cause multiple intracranial tumors (e.g., SMARCB1/LZTR1-related schwannomatosis, Cowden syndrome);
- Expected survival <12 months;
- Presence of severe psychiatric disorders or cognitive impairment that precludes cooperation with imaging or hearing assessments;
- Extreme social or geographic factors that, in the investigator's judgment, may impede follow-up for more than 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selumetinib 25mg/m2Also: Koselugo, AZD6244Oral twice daily per predetermined dosage per protocol. | Drug | Substudy A (Selumetinib) |
| LuvometinibAlso: FCN-159Oral once daily per predetermined dosage per protocol. | Drug | Substudy B (Luvometinib + Serplulimab) |
| SerplulimabAlso: HLX10Intravenous infusion per predetermined dosage per protocol. | Drug | Substudy B (Luvometinib + Serplulimab) |
Primary outcome
Tumor-Type-Specific Response Rate in NF2-SWN Tumors
Time frame: 12 months
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 or non-vestibular schwannoma: ORR is defined as at least a 20% reduction in target tumor volume from baseline. Ependymoma: ORR is defined as at least a 30% reduction in maximum diameter from baseline according to RECIST v1.1.
6 secondary outcomes
Incidence of Adverse Events in Interventional Substudies
Time frame: From first dose through 30 days after last dose (or as specified by individual substudy protocols)
Maximum Severity Grade of Adverse Events in Interventional Substudies
Time frame: 12 months
Incidence of Serious Adverse Events in Interventional Substudies
Time frame: From first dose through 30 days after last dose.
Incidence of Dose Modifications Due to Adverse Events
Time frame: From first dose through 30 days after last dose.
Incidence of Treatment Interruptions Due to Adverse Events
Time frame: From first dose through 30 days after last dose.
Incidence of Treatment Discontinuations Due to Adverse Events
Time frame: From first dose through 30 days after last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selumetinib 25mg/m2, Luvometinib and Serplulimab in people with Neurofibromatosis Type 2 and Vestibular Schwannoma, run by Beijing Tiantan Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-Type-Specific Response Rate in NF2-SWN Tumors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.