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NCT04296890 · OUTCOME

Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

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

ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

Analysis population: The investigator (INV) Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.

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 Soravtansine105

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine32.4Not reported23.642.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.6
        upper Limit
        42.2
        value
        32.4
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
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 investigator (INV) Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.
reporting Status
POSTED
time Frame
Up to approximately 15 months
title
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice