Study of Vimseltinib for Tenosynovial Giant Cell Tumor

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR). * CR: Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. Non-nodal targets must be absent. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

The ITT Set consisted of participants who were randomized to a study treatment regimen.

→

secondary · POSTED

TVS is a semi-quantitative magnetic resonance imaging (MRI) scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. ORR was the percentage of participants who achieved either CR or PR as assessed by blinded IRR using TVS. * CR: Lesion completely gone * PR: ≥50% decrease in volume score relative to Baseline.

The ITT Set consisted of participants who were randomized to a study treatment regimen.

→

secondary · POSTED

Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard).

The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.

→

secondary · POSTED

All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.

→

secondary · POSTED

The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness.

→

secondary · POSTED

The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

PROMIS · Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id: NCT05059262
qol key: qol-0003
source section id: NCT05059262-om-0003
source outcome index: 3
instrument: PROMIS
instrument basis: matched 'promis' in the study's own wording
scale title: Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25
measure definition: All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.
time frame: Baseline to Week 25 (Cycle 7, Day 1)
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores representing less physical function interference and better
population note: The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Brief Pain Inventory · Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id: NCT05059262
qol key: qol-0006
source section id: NCT05059262-om-0006
source outcome index: 6
instrument: Brief Pain Inventory
instrument basis: matched 'brief pain inventory' in the study's own wording
scale title: Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use
measure definition: Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use.
time frame: Baseline to Week 25 (Cycle 7, Day 1)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The ITT Set consisted of participants who were randomized to a study treatment regimen.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id: NCT05059262
trial label: Study of Vimseltinib for Tenosynovial Giant Cell Tumor
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0000
source section id
NCT05059262-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
endpoint definition
ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR). * CR: Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. Non-nodal targets must be absent. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
time origin
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0001
source section id
NCT05059262-om-0001
source outcome index
1
endpoint
ORR at Week 25 Per Tumor Volume Score (TVS)
endpoint definition
TVS is a semi-quantitative magnetic resonance imaging (MRI) scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. ORR was the percentage of participants who achieved either CR or PR as assessed by blinded IRR using TVS. * CR: Lesion completely gone * PR: ≥50% decrease in volume score relative to Baseline.
time origin
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0002
source section id
NCT05059262-om-0002
source outcome index
2
endpoint
Change From Baseline in Active Range of Motion (ROM) at Week 25
endpoint definition
Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard).
time origin
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0003
source section id
NCT05059262-om-0003
source outcome index
3
endpoint
Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25
endpoint definition
All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.
time origin
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0004
source section id
NCT05059262-om-0004
source outcome index
4
endpoint
Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25
endpoint definition
The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness.
time origin
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0005
source section id
NCT05059262-om-0005
source outcome index
5
endpoint
Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25
endpoint definition
The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state.
time origin
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0000
arm key
OG000
arm label
Vimseltinib
regimen
Participants received 30 mg BIW vimseltinib for 24 weeks.
analyzed count
83
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Participants received matching placebo BIW for 24 weeks.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0001
arm key
OG000
arm label
Vimseltinib
regimen
Participants received 30 mg BIW vimseltinib for 24 weeks.
analyzed count
83
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
Participants received matching placebo BIW for 24 weeks.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0002
arm key
OG000
arm label
Vimseltinib
regimen
Participants received 30 mg BIW vimseltinib for 24 weeks.
analyzed count
73
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0002
arm key
OG001
arm label
Placebo
regimen
Participants received matching placebo BIW for 24 weeks.
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0003
arm key
OG000
arm label
Vimseltinib
regimen
Participants received 30 mg BIW vimseltinib for 24 weeks.
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0003
arm key
OG001
arm label
Placebo
regimen
Participants received matching placebo BIW for 24 weeks.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0004
arm key
OG000
arm label
Vimseltinib
regimen
Participants received 30 mg BIW vimseltinib for 24 weeks.
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0004
arm key
OG001
arm label
Placebo
regimen
Participants received matching placebo BIW for 24 weeks.
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0005
arm key
OG000
arm label
Vimseltinib
regimen
Participants received 30 mg BIW vimseltinib for 24 weeks.
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
outcome key
om-0005
arm key
OG001
arm label
Placebo
regimen
Participants received matching placebo BIW for 24 weeks.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05059262-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
harm key
EG000
source section id
NCT05059262-ae
event group key
EG000
event group label
Total - Vimseltinib
serious affected
17
serious at risk
118
other affected
113
other at risk
118
frequency threshold
5
collection period
Collection of adverse events started from the signing of informed consent through safety follow-up (up to 1.68 years)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
harm key
EG001
source section id
NCT05059262-ae
event group key
EG001
event group label
Placebo
serious affected
1
serious at risk
39
other affected
32
other at risk
39
frequency threshold
5
collection period
Collection of adverse events started from the signing of informed consent through safety follow-up (up to 1.68 years)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
qol key
qol-0003
source section id
NCT05059262-om-0003
source outcome index
3
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25
measure definition
All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.
time frame
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores representing less physical function interference and better
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor-diffuse-type
nct id
NCT05059262
qol key
qol-0006
source section id
NCT05059262-om-0006
source outcome index
6
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use
measure definition
Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use.
time frame
Baseline to Week 25 (Cycle 7, Day 1)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The ITT Set consisted of participants who were randomized to a study treatment regimen.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice