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NCT04296890 · OUTCOME

Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression · Source last updated 2024-08-07

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
Up to approximately 15 months

What was measured

The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.

Analysis population: The CA-125-Evaluable population was defined as all participants who received at least 1 dose of study drug and whose pretreatment sample was ≥2.0 times the upper limit of normal (ULN), within 2 weeks prior to first dose of mirvetuximab soravtansine, and who had at least 1 postbaseline CA-125 evaluation.

Groups in this outcome

Mirvetuximab Soravtansine

Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).

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

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine86

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine46.5Not reported35.757.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.7
        upper Limit
        57.6
        value
        46.5
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
    id
    OG000
    title
    Mirvetuximab Soravtansine
param Type
NUMBER
population Description
The CA-125-Evaluable population was defined as all participants who received at least 1 dose of study drug and whose pretreatment sample was ≥2.0 times the upper limit of normal (ULN), within 2 weeks prior to first dose of mirvetuximab soravtansine, and who had at least 1 postbaseline CA-125 evaluation.
reporting Status
POSTED
time Frame
Up to approximately 15 months
title
Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice