WHO is the trial for?

• Patients ≥18 years of age with confirmed TGCT and for which surgical resection is not an option
• 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)
• Excluded are patients who received previous systemic therapy (investigational or approved) with a targeting colony stimulating factor 1 (CSF1) or CSFR1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed.

WHAT is the key question that this trial is attempting to answer?

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in TGCT and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

More about the importance and benefits of joining clinical trials: Please click here.

WHEN will the trial be open?

WHERE is the trial available?

The trial is being conducted in several study centers in the US, Australia, Canada, Netherlands, Poland, Spain, Switzerland and the UK. Further study sites are planned. For further information please check here.

Study contact:

Clinical Team
Phone: +1785-830-2100
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STUDY DESIGN: What does the study look like?

There are 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to vimseltinib, the other group will receive placebo. 

The study consists of two parts. In Part 1, 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.

Vimseltinib will be given at a dosage of 30 mg twice a week (biw) vimseltinib for 24 weeks in Part 1 and continue on 30 mg biw vimseltinib in Part 2.

HOW do I get more information?

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RESULTS of the study

No results are available at this time. Future results will be linked here.