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NCT04697628 · OUTCOME

Overall Survival

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer · Source last updated 2026-02-24

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)

What was measured

Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.

Analysis population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

Groups in this outcome

Tisotumab Vedotin

Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).

Chemotherapy

Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.

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

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin253
Chemotherapy249

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin11.5Not reported9.814.9Not reported
Chemotherapy9.5Not reported7.910.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.89
    estimate Comment
    Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0038
    p Value Comment
    Two-sided p-value calculated from stratified log-rank test.
    param Type
    Cox Proportional Hazard
    param Value
    0.70
    statistical Method
    Stratified log-rank test
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.89
    estimate Comment
    Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0038
    p Value Comment
    Two-sided p-value calculated from stratified log-rank test.
    param Type
    Cox Proportional Hazard
    param Value
    0.70
    statistical Method
    Stratified log-rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.8
        upper Limit
        14.9
        value
        11.5
      2. group Id
        OG001
        lower Limit
        7.9
        upper Limit
        10.7
        value
        9.5
denoms
  1. counts
    1. group Id
      OG000
      value
      253
    2. group Id
      OG001
      value
      249
    units
    Participants
description
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    id
    OG000
    title
    Tisotumab Vedotin
  2. description
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.
reporting Status
POSTED
time Frame
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice