Clinical trial · Interventional
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)
NCT05059262CI-TRIAL-00106072MOTIONactive not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Tumor of Tendon Sheath | Tenosynovial Giant Cell Tumor | ALIAS | 0.90 |
| Pigmented Villonodular Synovitis | Tenosynovial Giant Cell Tumor, Diffuse Type | ALIAS | 0.90 |
| Tenosynovial Giant Cell Tumor | Tenosynovial Giant Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Tenosynovial Giant Cell Tumor, Diffuse | Tenosynovial Giant Cell Tumor, Diffuse Type | ALIAS | 0.90 |
| Tenosynovial Giant Cell Tumor, Localized | Tenosynovial Giant Cell Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vimseltinib | Drug | Vimseltinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1/Part 2 - Vimseltinib/Vimseltinib
- description
- Participants received blinded treatment of 30 mg twice a week (BIW) vimseltinib for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2.
- interventionNames
- Drug: Vimseltinib
- type
- PLACEBO_COMPARATOR
- label
- Part 1/Part 2: Placebo/Vimseltinib
- description
- Participants received blinded treatment of BIW matching placebo for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2.
- interventionNames
- Drug: Vimseltinib
- Drug: Placebo
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥18 years of age 2. TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening) 3. Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record 4. Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol 5. Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug 6. Must have measurable disease, as per RECIST Version 1.1, with at least one lesion having a minimum size of 2cm 7. Adequate organ and bone marrow function 8. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements 9. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures 10. Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device Exclusion Criteria: 1. Previous use of systemic therapy (investigational or approved) targeting colony-stimulating factor 1 (CSF1) or colony-stimulating factor 1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed 2. Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening. 3. Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis) 4. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome 5. Concurrent treatment with any study-prohibited medications 6. Major surgery within 14 days of the first dose of study drug 7. Any clinically significant comorbidities 8. Active liver or biliary disease including nonalcoholic steatohepatitis (NASH) or cirrhosis 9. Malabsorption syndrome or other illness that could affect oral absorption 10. Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection 11. If female, the participant is pregnant or breastfeeding 12. Known allergy or hypersensitivity to any component of the study drug 13. Contraindication to MRI
References
Publications (2)
- DERIVEDGelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, Lopez Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martin-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herraez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. doi: 10.1016/S0140-6736(24)00885-7. Epub 2024 Jun 3. PMID 38843860
- DERIVEDTap WD, Sharma MG, Vallee M, Smith BD, Sherman ML, Ruiz-Soto R, de Sande MV, Randall RL, Bernthal NM, Gelderblom H. The MOTION study: a randomized, phase III study of vimseltinib for the treatment of tenosynovial giant cell tumor. Future Oncol. 2024 Mar;20(10):593-601. doi: 10.2217/fon-2023-0238. Epub 2023 Aug 18. PMID 37593881