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New pill could shrink rare joint tumors without surgery

NCT ID NCT05059262

Disease control Sponsor: Deciphera Pharmaceuticals, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests vimseltinib, an oral drug, for tenosynovial giant cell tumor (TGCT) when surgery isn't possible. About 123 adults with symptomatic TGCT will receive either vimseltinib or a placebo for 24 weeks, then all can get the drug. The main goal is to see if the drug shrinks tumors on MRI scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vimseltinib (a drug taken by mouth)
What this could lead to
If it works, this could offer a non-surgical treatment option for people with TGCT, shrinking tumors and easing symptoms.
What could go wrong
This is still an experimental drug. It may not shrink tumors enough, and side effects are possible. The trial is also relatively small (123 people).

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

123 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. 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

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Conditions

The condition(s) this trial relates to.

Giant Cell Tumor of Tendon Sheath tenosynovial giant cell tumor tenosynovial giant cell tumor, diffuse type tenosynovial giant cell tumor, localized type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Giant cell tumor of tendon sheath Pigmented villonodular synovitis Tenosynovial giant cell tumor Tenosynovial giant cell tumor, diffuse Tenosynovial giant cell tumor, localized

Contacts and locations

Locations

  • Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    London, United Kingdom

  • Centre Léon Bérard

    Lyon, France

  • Chris O'Brien Lifehouse

    Camperdown, Australia

  • City of Hope

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Sarcoma Research

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Fundacion Jimenez Diaz

    Madrid, Spain

  • Helios Klinikum Berlin-Buch

    Berlin, Germany

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Institut Bergonié

    Bordeaux, France

  • Institut Gustave Roussy

    Villejuif, France

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, Italy

  • Istituto Nazionale Tumori Regina Elena

    Rome, Italy

  • Istituto Oncologico Veneto

    Padua, Italy

  • Istituto Ortopedico Rizzoli

    Bologna, Italy

  • Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, Poland

  • Leiden University Medical Center

    Leiden, Netherlands

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902, United States

  • McGill University

    Montreal, Canada

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10016, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oslo University Hospital

    Oslo, Norway

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Princess Margaret Hospital

    Toronto, Canada

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University College London Hospitals

    London, United Kingdom

  • University Hospital Essen (Universitätsklinikum Essen)

    Essen, Germany

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Universitäts-Kinderspital beider Basel (UKBB)

    Basel, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.