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Tenosynovial Giant Cell TumorPhase 2NCT07499362

Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)

A Phase 2 study testing Pimicotinib in people with Tenosynovial Giant Cell Tumor, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 4 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tenosynovial Giant Cell Tumor
What is being tested?
Pimicotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesJapan
Study dates
26 Mar 2026to 22 Aug 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is [i.e.] it is located in a complex anatomical site, extensively invasive, and cannot be completely resected; or a surgical operation may cause dysfunction or serious complications). Symptomatic disease because of active TGCT, defined as a worst pain of greater than or equal to [>=] 4 within 2 weeks prior to enrollment (based on scale of 0 to 10, with 10 representing "pain as bad as you can imagine"), and/or a worst stiffness of >= 4 within 2 weeks prior to first dose of pimicotinib (based on a scale of 0 to 10, with 10 representing "stiffness as bad as you can imagine")
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to [<=] 1
  • Participants with adequate hepatic, renal hematologic functions
  • Other protocol defined inclusion criteria may apply

Who cannot join

  • Known additional malignancy that required active treatment and may affect the participant's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ
  • Serious gastrointestinal bleeding within 3 months of first dose of pimicotinib or factors that significantly affected the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small-bowel resection, etc.
  • Impaired cardiac function or clinically significant cardiac disease, including any one of the following: New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure; prolongation of the rate corrected QT interval based on repeated demonstration of QT interval corrected using Fridericia's formula (QTcF) greater than (>) 480 milliseconds (ms), or history of long QT interval corrected (QTc) syndrome; Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%) or below the lower limit of normal, whichever is higher
  • Cerebrovascular accident/stroke (within 6 months of first dose of pimicotinib)
  • Other protocol defined exclusion criteria may apply

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Communication Center contact

+49 6151 72 5200

service@emdgroup.com

Japan4 sites, 4 recruiting

  • National Cancer Center Hospital

    Chūōku

    Recruiting

  • Kyushu University Hospital - 300173484

    Fukuoka

    Recruiting

  • Kanazawa University Hospital

    Kanazawa

    Recruiting

  • Nagoya University Hospital - 300176284

    Nagoya

    Recruiting

Other trials in Japan

About this study

Official title: Phase 2, Single-arm Study to Investigate the Tolerability, Pharmacokinetics, Efficacy, and Safety of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor

The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT

Read the detailed description

The purpose of this study is to assess the tolerability, pharmacokinetics (PK), efficacy, and safety of pimicotinib in Japanese participants with TGCT in two cohorts: Safety Run-in and Expansion.

Being tested
Pimicotinib
Keywords
Nodular TGCT, diffuse TGCT, giant cell tumor of tendon sheath, colony-stimulating factor 1 receptor (CSF-1R) inhibitor
Medical subject headings
Giant Cell Tumor of Tendon Sheath

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PimicotinibDrug

    In the Safety Run-in Cohort, participants will receive 50 milligrams (mg) of pimicotinib once daily (QD), orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason. The Safety Monitoring Committee (SMC) will monitor and assess tolerability of pimicotinib 50 mg QD during the safety run-in cohort. After making a recommendation about opening the Expansion Cohort based on the assessment in safety run-in cohort, participants will receive 50 mg of pimicotinib monotherapy QD, orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason.

Study groups in NCT07499362
Study groupRoleWhat they receive
Safety Run-In followed by Expansion Cohort: PimicotinibExperimentalNot described
Receives: Drug: Pimicotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Run-In Cohort: Number of Participants with Dose Limiting Toxicity (DLT)-like events

    Measured: Day 1 up to Day 28 of Cycle 1 (each cycle is of 28 days)

  2. Safety Run-In Cohort: Pharmacokinetic (PK) Plasma Concentration of Pimicotinib

    Measured: Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)

  3. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee

    Measured: Time from first study treatment until progressive disease or death, assessed up to approximately 2 years

Secondary outcomes (16)

  1. Objective Response (OR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)

    Measured: Time from first study treatment until progressive disease or death, assessed up to approximately 2 years

  2. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator

    Measured: Time from first study treatment until progressive disease or death, assessed up to approximately 2 years

  3. Mean Change from Baseline in Range of Motion (ROM) at Week 25

    The ROM of the affected joint or tumor site will be assessed using a goniometer. Measurements will be recorded in degrees.

    Measured: Baseline, Week 25

  4. Mean Change from Baseline in Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25

    Measured: Baseline, Week 25

  5. Mean Change from Baseline in Brief Pain Inventory (BPI)- Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25

    Measured: Baseline, Week 25

  6. Mean Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning Score at Week 25

    The PROMIS Physical Function scale is measured using a series of questions assessing a person's ability to perform various physical tasks, with responses scored on a 5-point Likert scale. The raw score from these responses is then converted to a standardized T-score on a scale of 0 to 100, with a mean of 50 and a standard deviation of 10. The total score is the final T-score.

    Measured: Baseline, Week 25

  7. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee

    Measured: Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years

  8. Duration of Response (DOR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)

    Measured: Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years

  9. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator

    Measured: Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years

  10. Mean Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Scale Score at Week 25

    The EQ-5D-5L questionnaire is a standardized instrument used as a measure of health outcome. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: an extreme problem. Higher scores (closer to 5) indicate worse health status.

    Measured: Baseline, Week 25

  11. Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Week 25

    The EQ-5D-5L questionnaire is a standardized instrument used as a measure of health outcome. The VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled 'Worst imaginable health state' and 'Best imaginable health state'. VAS ranges from 0 to 100. Higher scores indicate better perceived health.

    Measured: Baseline, Week 25

  12. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events

    Measured: Time from first study treatment, assessed up to approximately 2 years

  13. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Pimicotinib

    Measured: Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)

  14. Accumulation Ratio for Maximum Observed Plasma Concentration [Racc(Cmax)] of Pimicotinib After Repeated Administration

    Measured: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15 (each cycle is of 28 days)

  15. Accumulation Ratio of Area Under the Plasma Concentration-Time Curve from Time Zero to 24 Hours (AUC0-24) of Pimicotinib After Repeated Administration

    Measured: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15 (each cycle is of 28 days)

  16. Plasma Concentration Observed at the End of a Dosing Interval Immediately before Next Dosing (Ctrough) of Pimicotinib

    Measured: Pre-dose on Cycle 1 Day 15 (each cycle is of 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start26 Mar 2026
  3. Primary completion22 Aug 2028 (estimated)
  4. Study completion22 Aug 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499362
Sponsor's protocol ID
MS265601_0008
Other IDs
jRCT2071250149
Status last verified
Oct 2026
First submitted
23 Mar 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD supporting publicly available results will be evaluated for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pimicotinib in people with Tenosynovial Giant Cell Tumor, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 4 sites in Japan.

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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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?

Contact Communication Center (+49 6151 72 5200, service@emdgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Run-In Cohort: Number of Participants with Dose Limiting Toxicity (DLT)-like events (time frame: Day 1 up to Day 28 of Cycle 1 (each cycle is of 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07499362.

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 23 Oct 2026.

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