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NCT03070392 · OUTCOME

Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma · Source last updated 2026-03-17

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

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
Time frame
EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.

What was measured

The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement.

Analysis population: The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.

Groups in this outcome

Tebentafusp

Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.

Investigator's Choice

1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable 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
Tebentafusp252
Investigator's Choice126

Reported measurements

Baseline Cycle 1

Analysis denominator · Participants

GroupSource count
Tebentafusp194
Investigator's Choice78
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp81.016.36Not reportedNot reportedNot reported
Investigator's Choice80.418.31Not reportedNot reportedNot reported
Change at Cycle 3

Analysis denominator · Participants

GroupSource count
Tebentafusp136
Investigator's Choice45
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp0.414.69Not reportedNot reportedNot reported
Investigator's Choice-0.814.28Not reportedNot reportedNot reported
Change at Cycle 5

Analysis denominator · Participants

GroupSource count
Tebentafusp108
Investigator's Choice28
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp0.615.61Not reportedNot reportedNot reported
Investigator's Choice-0.714.38Not reportedNot reportedNot reported
Change at Cycle 9

Analysis denominator · Participants

GroupSource count
Tebentafusp71
Investigator's Choice14
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-0.919.81Not reportedNot reportedNot reported
Investigator's Choice-3.313.30Not reportedNot reportedNot reported
Change at Cycle 13

Analysis denominator · Participants

GroupSource count
Tebentafusp47
Investigator's Choice9
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-2.016.48Not reportedNot reportedNot reported
Investigator's Choice-2.68.37Not reportedNot reportedNot reported
Change at Cycle 17

Analysis denominator · Participants

GroupSource count
Tebentafusp22
Investigator's Choice6
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-10.220.93Not reportedNot reportedNot reported
Investigator's Choice-8.533.82Not reportedNot reportedNot reported
Change at Cycle 21

Analysis denominator · Participants

GroupSource count
Tebentafusp13
Investigator's Choice2
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-1.814.52Not reportedNot reportedNot reported
Investigator's Choice-1.05.66Not reportedNot reportedNot reported
Change at Cycle 25

Analysis denominator · Participants

GroupSource count
Tebentafusp8
Investigator's Choice1
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-13.619.43Not reportedNot reportedNot reported
Investigator's Choice-4.0NANot reportedNot reportedNot calculable due to single participant
Change at Cycle 29

Analysis denominator · Participants

GroupSource count
Tebentafusp9
Investigator's Choice2
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp0.09.25Not reportedNot reportedNot reported
Investigator's Choice-2.01.41Not reportedNot reportedNot reported
Change at EOT

Analysis denominator · Participants

GroupSource count
Tebentafusp95
Investigator's Choice45
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-10.122.53Not reportedNot reportedNot reported
Investigator's Choice-11.721.40Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.36
        value
        81.0
      2. group Id
        OG001
        spread
        18.31
        value
        80.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        194
      2. group Id
        OG001
        value
        78
      units
      Participants
    title
    Baseline Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.69
        value
        0.4
      2. group Id
        OG001
        spread
        14.28
        value
        -0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Change at Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.61
        value
        0.6
      2. group Id
        OG001
        spread
        14.38
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    Change at Cycle 5
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.81
        value
        -0.9
      2. group Id
        OG001
        spread
        13.30
        value
        -3.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Change at Cycle 9
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.48
        value
        -2.0
      2. group Id
        OG001
        spread
        8.37
        value
        -2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Change at Cycle 13
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.93
        value
        -10.2
      2. group Id
        OG001
        spread
        33.82
        value
        -8.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Change at Cycle 17
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.52
        value
        -1.8
      2. group Id
        OG001
        spread
        5.66
        value
        -1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Change at Cycle 21
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.43
        value
        -13.6
      2. comment
        Not calculable due to single participant
        group Id
        OG001
        spread
        NA
        value
        -4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Change at Cycle 25
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.25
        value
        0.0
      2. group Id
        OG001
        spread
        1.41
        value
        -2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Change at Cycle 29
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.53
        value
        -10.1
      2. group Id
        OG001
        spread
        21.40
        value
        -11.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Change at EOT
denoms
  1. counts
    1. group Id
      OG000
      value
      252
    2. group Id
      OG001
      value
      126
    units
    Participants
description
The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
    id
    OG000
    title
    Tebentafusp
  2. description
    1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.
    id
    OG001
    title
    Investigator's Choice
param Type
MEAN
population Description
The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
reporting Status
POSTED
time Frame
EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
title
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice