Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor
1 other identifier
interventional
94
7 countries
40
Brief Summary
The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are:
- Whether the Pimicotinib(ABSK021) works well in patients with TGCT.
- Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. Participants will be asked to complete the study procedures:
- Receive the administration of Pimicotinib(ABSK021) or placebo (a placebo is a look-alike substance that contains no active drug) about 24 weeks in study part 1.
- Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2.
- Receive the administration of Pimicotinib(ABSK021) till study end in study part 3.
- Complete the study procedures speficied in the protocol, which is guided by researchers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2023
Longer than P75 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2024
CompletedResults Posted
Study results publicly available
May 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
ExpectedMay 4, 2026
April 1, 2026
1.4 years
March 13, 2023
April 7, 2026
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Baseline to Week 25
Secondary Outcomes (5)
Objective Response Rate (ORR) Per Tumor Volumn Score (TVS)
Baseline to Week 25
Change From Baseline in Active Range of Motion (ROM) at Week 25
Baseline to Week 25
Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25
Baseline to Week 25
Change From Baseline in Brief Pain Inventory (BPI) Worst Pain NRS Score at Week 25
Baseline to Week 25
Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25
Baseline to Week 25
Study Arms (2)
Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
EXPERIMENTALParticipants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2 and Part 3.
Part 1- Placebo/ Pimicotinib(ABSK021)
PLACEBO COMPARATORParticipants receive the blinded treatment of matching placebo for 24 weeks in Part 1 and have option to receive the open-label Pimicotinib(ABSK021) in Part 2.
Interventions
capsule
Eligibility Criteria
You may qualify if:
- Patients should understand the study procedures and sign the informed consent form prior to screening.
- Age ≥ 18 years.
- A histologically confirmed TGCT with unresectable.
- Measurable disease as defined by RECIST 1.1, and with at least one lesion of ≥ 2 cm.
- Stable prescription of analgesic regimen for patients with an analgesic need.
- Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol.
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1.
- Adequate organ function and bone marrow function.
You may not qualify if:
- Known allergy or hypersensitivity to any components of the investigational drug product.
- Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R. Previous therapy with imatinib and nilotinib is allowed.
- Known additional malignancy that required active treatment and may affect the patient's participation in the study or affect the outcome of the study as assessed by the Investigator.
- Known metastatic TGCT.
- Significant concomitant arthropathy in the affected joint, serious disease, uncontrolled infection.
- Known MRI contraindications.
- Has factors that significantly affected the absorption of oral drug.
- Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization.
- Concomitant use of strong CYP inhibitors or inducers as outlined in study protocol.
- Impaired cardiac function or clinically significant cardiac disease.
- Known active human immunodeficiency virus, active hepatitis B, active hepatitis C, or known active tuberculosis.
- Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.
- Pregnant or lactating women.
- Childbearing potential males or non-surgically sterilized female patients must agree to use effective methods of contraception during the study.
- Any other clinically significant comorbidities, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Precision NextGen Oncology
Beverly Hills, California, 90212, United States
Duke University Medical Center
Durham, California, 27710, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
McGill University Health Center
Montreal, Canada
Princess Margaret Cancer Center
Toronto, Canada
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, Hubei, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xi'an Honghui Hospital
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Wuhan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Beijing Jishuitan Hospital
Beijing, China
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Ospedale di Prato
Prato, Italy
Leiden University Medical Center
Leiden, 2333, Netherlands
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Related Publications (2)
Xu H, Niu X, Ravi V, Martin-Broto J, Razak AA, Saleh R, Zhou Y, Shen J, Liu T, Sankhala KK, Serrano C, Stacchiotti S, Wang J, Baldi GG, Feng Y, Hua Y, Li T, Rutkowski P, Zhang X, Tinoco G, Zou Q, Shan B, Zhu X, Gelderblom H. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Mar 14;407(10533):1072-1083. doi: 10.1016/S0140-6736(25)02602-9. Epub 2026 Mar 5.
PMID: 41796601DERIVEDNiu X, Ravi V, Shan B, Guo Q, Shi H, Zou Q, Gelderblom H. MANEUVER: A Phase III study of pimicotinib to assess efficacy and safety in tenosynovial giant cell tumor patients. Future Oncol. 2026 Feb;22(5):507-514. doi: 10.1080/14796694.2024.2396227. Epub 2024 Sep 17.
PMID: 39287124DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Yi Liu, Senior Medical Director
- Organization
- Abbisko Therapeutics Co, Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
April 7, 2023
Study Start
April 27, 2023
Primary Completion
September 23, 2024
Study Completion (Estimated)
June 1, 2028
Last Updated
May 4, 2026
Results First Posted
May 4, 2026
Record last verified: 2026-04