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NCT04697628 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        23
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        122
      2. group Id
        FG001
        num Subjects
        91
      type
      On-going in study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        253
      2. group Id
        FG001
        num Subjects
        249
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        250
      2. group Id
        FG001
        num Subjects
        239
      type
      Treated
    3. achievements
      1. comment
        Completers include participants who died from any cause.
        group Id
        FG000
        num Subjects
        114
      2. comment
        Completers include participants who died from any cause.
        group Id
        FG001
        num Subjects
        131
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        139
      2. group Id
        FG001
        num Subjects
        118
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 660 participants were screened of which 158 participants failed screening and 502 participants were enrolled in the study.
recruitment Details
Participants with recurrent/metastatic cervical cancer (rCC/mCC) who received 1 or 2 prior lines of systemic therapy for their recurrent or metastatic disease were included.
Complete source fields
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
    FG000
    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
    FG001
    title
    Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        23
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        122
      2. group Id
        FG001
        num Subjects
        91
      type
      On-going in study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        253
      2. group Id
        FG001
        num Subjects
        249
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        250
      2. group Id
        FG001
        num Subjects
        239
      type
      Treated
    3. achievements
      1. comment
        Completers include participants who died from any cause.
        group Id
        FG000
        num Subjects
        114
      2. comment
        Completers include participants who died from any cause.
        group Id
        FG001
        num Subjects
        131
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        139
      2. group Id
        FG001
        num Subjects
        118
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 660 participants were screened of which 158 participants failed screening and 502 participants were enrolled in the study.
recruitment Details
Participants with recurrent/metastatic cervical cancer (rCC/mCC) who received 1 or 2 prior lines of systemic therapy for their recurrent or metastatic disease were included.

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Preserved source evidence · Not medical advice