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NCT05059262 · OUTCOME

Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

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 with CR or PR
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Week 25 (Cycle 7, Day 1)

What was measured

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.

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 with CR or PR · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vimseltinib39.8Not reported29.251.1Not 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
    28.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    49.6
    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 Interactive Response Technology (IRT).
    param Type
    Difference in ORR
    param Value
    39.0
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    28.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    49.6
    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 Interactive Response Technology (IRT).
    param Type
    Difference in ORR
    param Value
    39.0
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.2
        upper Limit
        51.1
        value
        39.8
      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
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.
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
Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
type
PRIMARY
unit Of Measure
percentage of participants with CR or PR

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

Preserved source evidence · Not medical advice