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NCT03070392 · OUTCOME

Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status

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
EORTC QLQ-C30 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

Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. 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
Tebentafusp173
Investigator's Choice65
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp76.10820.233Not reportedNot reportedNot reported
Investigator's Choice74.87220.439Not reportedNot reportedNot reported
Change at Cycle 3

Analysis denominator · Participants

GroupSource count
Tebentafusp105
Investigator's Choice35
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp0.95216.274Not reportedNot reportedNot reported
Investigator's Choice-0.23814.919Not reportedNot reportedNot reported
Change at Cycle 5

Analysis denominator · Participants

GroupSource count
Tebentafusp94
Investigator's Choice22
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-1.15220.797Not reportedNot reportedNot reported
Investigator's Choice-10.22722.557Not reportedNot reportedNot reported
Change at Cycle 9

Analysis denominator · Participants

GroupSource count
Tebentafusp57
Investigator's Choice13
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-2.19319.577Not reportedNot reportedNot reported
Investigator's Choice-8.33313.176Not reportedNot reportedNot reported
Change at Cycle 13

Analysis denominator · Participants

GroupSource count
Tebentafusp40
Investigator's Choice9
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-5.62517.641Not reportedNot reportedNot reported
Investigator's Choice-10.18516.017Not reportedNot reportedNot reported
Change at Cycle 17

Analysis denominator · Participants

GroupSource count
Tebentafusp18
Investigator's Choice6
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-10.18528.087Not reportedNot reportedNot reported
Investigator's Choice-4.1676.972Not reportedNot reportedNot reported
Change at Cycle 21

Analysis denominator · Participants

GroupSource count
Tebentafusp11
Investigator's Choice2
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp0.75818.429Not reportedNot reportedNot reported
Investigator's Choice-4.1675.893Not reportedNot reportedNot reported
Change at Cycle 25

Analysis denominator · Participants

GroupSource count
Tebentafusp7
Investigator's Choice1
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-2.38127.936Not reportedNot reportedNot reported
Investigator's Choice0.000.00Not reportedNot reportedNot reported
Change at Cycle 29

Analysis denominator · Participants

GroupSource count
Tebentafusp6
Investigator's Choice1
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-8.33319.720Not reportedNot reportedNot reported
Investigator's Choice0.000.00Not reportedNot reportedNot reported
Change at EOT

Analysis denominator · Participants

GroupSource count
Tebentafusp76
Investigator's Choice34
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tebentafusp-10.41720.911Not reportedNot reportedNot reported
Investigator's Choice-10.53923.148Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.233
        value
        76.108
      2. group Id
        OG001
        spread
        20.439
        value
        74.872
    denoms
    1. counts
      1. group Id
        OG000
        value
        173
      2. group Id
        OG001
        value
        65
      units
      Participants
    title
    Baseline Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.274
        value
        0.952
      2. group Id
        OG001
        spread
        14.919
        value
        -0.238
    denoms
    1. counts
      1. group Id
        OG000
        value
        105
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    Change at Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.797
        value
        -1.152
      2. group Id
        OG001
        spread
        22.557
        value
        -10.227
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Change at Cycle 5
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.577
        value
        -2.193
      2. group Id
        OG001
        spread
        13.176
        value
        -8.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Change at Cycle 9
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.641
        value
        -5.625
      2. group Id
        OG001
        spread
        16.017
        value
        -10.185
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Change at Cycle 13
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.087
        value
        -10.185
      2. group Id
        OG001
        spread
        6.972
        value
        -4.167
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Change at Cycle 17
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.429
        value
        0.758
      2. group Id
        OG001
        spread
        5.893
        value
        -4.167
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Change at Cycle 21
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.936
        value
        -2.381
      2. group Id
        OG001
        spread
        0.00
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Change at Cycle 25
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.720
        value
        -8.333
      2. group Id
        OG001
        spread
        0.00
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Change at Cycle 29
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.911
        value
        -10.417
      2. group Id
        OG001
        spread
        23.148
        value
        -10.539
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        34
      units
      Participants
    title
    Change at EOT
denoms
  1. counts
    1. group Id
      OG000
      value
      252
    2. group Id
      OG001
      value
      126
    units
    Participants
description
Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. 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
EORTC QLQ-C30 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 EORTC QLQ-C30 Global Health Status
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice