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NCT02552121 · OUTCOME

Part 2: Progression Free Survival (PFS)

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2021-04-08

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to end of trial (Part 2), up to 36 weeks

What was measured

Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.

Groups in this outcome

Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian

Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).

Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical

Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).

Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian

Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).

Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical

Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).

Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian

Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.

Part 2: Cohort Expansion: Cohort 6 1q3w Cervical

Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.

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

Analysis denominator · Participants

GroupSource count
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian4
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical2
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian1
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical4
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian1
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical3

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian10.7Not reported2.0NACould not be estimated due to the low number of events disease progression or death.
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical8.0Not reported4.3NACould not be estimated due to the low number of events disease progression or death.
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian22.0Not reportedNANACould not be estimated due to the low number of events disease progression or death.
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical14.0Not reported9.1NACould not be estimated due to the low number of events disease progression or death.
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian5.0Not reportedNANACould not be estimated due to the low number of events disease progression or death.
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical11.9Not reported11.017.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be estimated due to the low number of events disease progression or death.
        group Id
        OG000
        lower Limit
        2.0
        upper Limit
        NA
        value
        10.7
      2. comment
        Could not be estimated due to the low number of events disease progression or death.
        group Id
        OG001
        lower Limit
        4.3
        upper Limit
        NA
        value
        8.0
      3. comment
        Could not be estimated due to the low number of events disease progression or death.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        22.0
      4. comment
        Could not be estimated due to the low number of events disease progression or death.
        group Id
        OG003
        lower Limit
        9.1
        upper Limit
        NA
        value
        14.0
      5. comment
        Could not be estimated due to the low number of events disease progression or death.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        5.0
      6. group Id
        OG005
        lower Limit
        11.0
        upper Limit
        17.1
        value
        11.9
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
    id
    OG000
    title
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
  2. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
    id
    OG001
    title
    Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
  3. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
    id
    OG002
    title
    Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
  4. description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
    id
    OG003
    title
    Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
  5. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
    id
    OG004
    title
    Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
  6. description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
    id
    OG005
    title
    Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
param Type
MEDIAN
reporting Status
POSTED
time Frame
Baseline to end of trial (Part 2), up to 36 weeks
title
Part 2: Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice