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NCT05059262 · OUTCOME

ORR at Week 25 Per Tumor Volume Score (TVS)

Study of Vimseltinib for Tenosynovial Giant Cell Tumor · Source last updated 2026-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Week 25 (Cycle 7, Day 1)

What was measured

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.

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

Groups in this outcome

Vimseltinib

Participants received 30 mg BIW vimseltinib for 24 weeks.

Placebo

Participants received matching placebo BIW for 24 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Vimseltinib83
Placebo40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vimseltinib67.5Not reported56.377.4Not reported
Placebo0Not reported0.08.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    57.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    77.3
    estimate Comment
    Stratified Mantel-Haenszel with stratification factors based on IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.
    param Type
    Difference in ORR
    param Value
    67.2
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    57.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    77.3
    estimate Comment
    Stratified Mantel-Haenszel with stratification factors based on IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.
    param Type
    Difference in ORR
    param Value
    67.2
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.3
        upper Limit
        77.4
        value
        67.5
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        8.8
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      40
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 30 mg BIW vimseltinib for 24 weeks.
    id
    OG000
    title
    Vimseltinib
  2. description
    Participants received matching placebo BIW for 24 weeks.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
The ITT Set consisted of participants who were randomized to a study treatment regimen.
reporting Status
POSTED
time Frame
Baseline to Week 25 (Cycle 7, Day 1)
title
ORR at Week 25 Per Tumor Volume Score (TVS)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice