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NCT03070392 · OUTCOME

Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores

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 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

General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse 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

Group	Source count
Tebentafusp	252
Investigator's Choice	126

Reported measurements

Mobility - Baseline Cycle 1

Analysis denominator · Participants

Group	Source count
Tebentafusp	194
Investigator's Choice	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	1.2	0.62	Not reported	Not reported	Not reported
Investigator's Choice	1.3	0.55	Not reported	Not reported	Not reported

Mobility - Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Tebentafusp	136
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.1	0.66	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.47	Not reported	Not reported	Not reported

Mobility - Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Tebentafusp	108
Investigator's Choice	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.73	Not reported	Not reported	Not reported
Investigator's Choice	0.3	0.65	Not reported	Not reported	Not reported

Mobility - Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Tebentafusp	71
Investigator's Choice	14

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.91	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.55	Not reported	Not reported	Not reported

Mobility - Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Tebentafusp	47
Investigator's Choice	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.1	0.60	Not reported	Not reported	Not reported
Investigator's Choice	0.3	0.87	Not reported	Not reported	Not reported

Mobility - Change at Cycle 17

Analysis denominator · Participants

Group	Source count
Tebentafusp	22
Investigator's Choice	6

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.3	0.57	Not reported	Not reported	Not reported
Investigator's Choice	0.2	0.41	Not reported	Not reported	Not reported

Mobility - Change at Cycle 21

Analysis denominator · Participants

Group	Source count
Tebentafusp	13
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.58	Not reported	Not reported	Not reported
Investigator's Choice	0.5	0.71	Not reported	Not reported	Not reported

Mobility - Change at Cycle 25

Analysis denominator · Participants

Group	Source count
Tebentafusp	8
Investigator's Choice	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.64	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Mobility - Change at Cycle 29

Analysis denominator · Participants

Group	Source count
Tebentafusp	9
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.50	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Mobility - Change at EOT

Analysis denominator · Participants

Group	Source count
Tebentafusp	95
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.3	0.73	Not reported	Not reported	Not reported
Investigator's Choice	0.4	0.99	Not reported	Not reported	Not reported

Self-care - Baseline Cycle 1

Analysis denominator · Participants

Group	Source count
Tebentafusp	194
Investigator's Choice	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	1.1	0.45	Not reported	Not reported	Not reported
Investigator's Choice	1.1	0.29	Not reported	Not reported	Not reported

Self-care - Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Tebentafusp	136
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.49	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.26	Not reported	Not reported	Not reported

Self-care - Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Tebentafusp	108
Investigator's Choice	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.42	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Self-care - Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Tebentafusp	71
Investigator's Choice	14

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.58	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Self-care - Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Tebentafusp	47
Investigator's Choice	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.52	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.33	Not reported	Not reported	Not reported

Self-care - Change at Cycle 17

Analysis denominator · Participants

Group	Source count
Tebentafusp	22
Investigator's Choice	6

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.68	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Self-care - Change at Cycle 21

Analysis denominator · Participants

Group	Source count
Tebentafusp	13
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.00	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Self-care - Change at Cycle 25

Analysis denominator · Participants

Group	Source count
Tebentafusp	8
Investigator's Choice	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.00	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Self-care - Change at Cycle 29

Analysis denominator · Participants

Group	Source count
Tebentafusp	9
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.00	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Self-care - Change at EOT

Analysis denominator · Participants

Group	Source count
Tebentafusp	95
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.60	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.56	Not reported	Not reported	Not reported

Usual activities - Baseline Cycle 1

Analysis denominator · Participants

Group	Source count
Tebentafusp	194
Investigator's Choice	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	1.2	0.53	Not reported	Not reported	Not reported
Investigator's Choice	1.3	0.55	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Tebentafusp	136
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.2	0.59	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.73	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Tebentafusp	108
Investigator's Choice	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.61	Not reported	Not reported	Not reported
Investigator's Choice	0.2	0.61	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Tebentafusp	71
Investigator's Choice	14

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.2	0.87	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.53	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Tebentafusp	47
Investigator's Choice	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.3	0.79	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.60	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 17

Analysis denominator · Participants

Group	Source count
Tebentafusp	22
Investigator's Choice	6

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.5	0.80	Not reported	Not reported	Not reported
Investigator's Choice	0.2	0.41	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 21

Analysis denominator · Participants

Group	Source count
Tebentafusp	13
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.3	0.48	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 25

Analysis denominator · Participants

Group	Source count
Tebentafusp	8
Investigator's Choice	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.3	0.46	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Usual activities - Change at Cycle 29

Analysis denominator · Participants

Group	Source count
Tebentafusp	9
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.2	0.44	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Usual activities - Change at EOT

Analysis denominator · Participants

Group	Source count
Tebentafusp	95
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.4	0.77	Not reported	Not reported	Not reported
Investigator's Choice	0.5	0.87	Not reported	Not reported	Not reported

Pain/Discomfort - Baseline Cycle 1

Analysis denominator · Participants

Group	Source count
Tebentafusp	194
Investigator's Choice	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	1.5	0.71	Not reported	Not reported	Not reported
Investigator's Choice	1.5	0.73	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Tebentafusp	136
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.75	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.73	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Tebentafusp	108
Investigator's Choice	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.65	Not reported	Not reported	Not reported
Investigator's Choice	0.2	0.72	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Tebentafusp	71
Investigator's Choice	14

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.73	Not reported	Not reported	Not reported
Investigator's Choice	-0.1	0.73	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Tebentafusp	47
Investigator's Choice	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.51	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.93	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 17

Analysis denominator · Participants

Group	Source count
Tebentafusp	22
Investigator's Choice	6

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.4	0.85	Not reported	Not reported	Not reported
Investigator's Choice	0.3	0.52	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 21

Analysis denominator · Participants

Group	Source count
Tebentafusp	13
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.2	0.55	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Pain/Discomfort - Change at Cycle 25

Analysis denominator · Participants

Group	Source count
Tebentafusp	8
Investigator's Choice	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.0	0.53	Not reported	Not reported	Not reported
Investigator's Choice	1.0	NA	Not reported	Not reported	Not calculable due to single participant.

Pain/Discomfort - Change at Cycle 29

Analysis denominator · Participants

Group	Source count
Tebentafusp	9
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.1	0.60	Not reported	Not reported	Not reported
Investigator's Choice	0.5	0.71	Not reported	Not reported	Not reported

Pain/Discomfort - Change at EOT

Analysis denominator · Participants

Group	Source count
Tebentafusp	95
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.2	0.87	Not reported	Not reported	Not reported
Investigator's Choice	0.4	1.10	Not reported	Not reported	Not reported

Anxiety/Depression - Baseline Cycle 1

Analysis denominator · Participants

Group	Source count
Tebentafusp	194
Investigator's Choice	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	1.8	0.94	Not reported	Not reported	Not reported
Investigator's Choice	1.7	0.89	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Tebentafusp	136
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.2	0.77	Not reported	Not reported	Not reported
Investigator's Choice	-0.3	0.55	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Tebentafusp	108
Investigator's Choice	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.2	0.74	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.61	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Tebentafusp	71
Investigator's Choice	14

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.3	0.80	Not reported	Not reported	Not reported
Investigator's Choice	0.1	0.77	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Tebentafusp	47
Investigator's Choice	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.4	0.77	Not reported	Not reported	Not reported
Investigator's Choice	-0.1	0.60	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 17

Analysis denominator · Participants

Group	Source count
Tebentafusp	22
Investigator's Choice	6

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.4	0.85	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 21

Analysis denominator · Participants

Group	Source count
Tebentafusp	13
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.5	0.88	Not reported	Not reported	Not reported
Investigator's Choice	0.0	0.00	Not reported	Not reported	Not reported

Anxiety/Depression - Change at Cycle 25

Analysis denominator · Participants

Group	Source count
Tebentafusp	8
Investigator's Choice	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.4	0.74	Not reported	Not reported	Not reported
Investigator's Choice	0.0	NA	Not reported	Not reported	Not calculable due to single participant.

Anxiety/Depression - Change at Cycle 29

Analysis denominator · Participants

Group	Source count
Tebentafusp	9
Investigator's Choice	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	-0.6	0.88	Not reported	Not reported	Not reported
Investigator's Choice	0.5	0.71	Not reported	Not reported	Not reported

Anxiety/Depression - Change at EOT

Analysis denominator · Participants

Group	Source count
Tebentafusp	95
Investigator's Choice	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tebentafusp	0.3	0.94	Not reported	Not reported	Not reported
Investigator's Choice	0.2	1.07	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.62
value
1.2
group Id
OG001
spread
0.55
value
1.3
denoms
counts
group Id
OG000
value
194
group Id
OG001
value
78
units
Participants
title
Mobility - Baseline Cycle 1
categories
measurements
group Id
OG000
spread
0.66
value
-0.1
group Id
OG001
spread
0.47
value
0.1
denoms
counts
group Id
OG000
value
136
group Id
OG001
value
45
units
Participants
title
Mobility - Change at Cycle 3
categories
measurements
group Id
OG000
spread
0.73
value
0.0
group Id
OG001
spread
0.65
value
0.3
denoms
counts
group Id
OG000
value
108
group Id
OG001
value
28
units
Participants
title
Mobility - Change at Cycle 5
categories
measurements
group Id
OG000
spread
0.91
value
0.0
group Id
OG001
spread
0.55
value
0.0
denoms
counts
group Id
OG000
value
71
group Id
OG001
value
14
units
Participants
title
Mobility - Change at Cycle 9
categories
measurements
group Id
OG000
spread
0.60
value
-0.1
group Id
OG001
spread
0.87
value
0.3
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
9
units
Participants
title
Mobility - Change at Cycle 13
categories
measurements
group Id
OG000
spread
0.57
value
0.3
group Id
OG001
spread
0.41
value
0.2
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
6
units
Participants
title
Mobility - Change at Cycle 17
categories
measurements
group Id
OG000
spread
0.58
value
0.0
group Id
OG001
spread
0.71
value
0.5
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
2
units
Participants
title
Mobility - Change at Cycle 21
categories
measurements
group Id
OG000
spread
0.64
value
0.1
group Id
OG001
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
1
units
Participants
title
Mobility - Change at Cycle 25
categories
measurements
group Id
OG000
spread
0.50
value
0.0
group Id
OG001
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
2
units
Participants
title
Mobility - Change at Cycle 29
categories
measurements
group Id
OG000
spread
0.73
value
0.3
group Id
OG001
spread
0.99
value
0.4
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
45
units
Participants
title
Mobility - Change at EOT
categories
measurements
group Id
OG000
spread
0.45
value
1.1
group Id
OG001
spread
0.29
value
1.1
denoms
counts
group Id
OG000
value
194
group Id
OG001
value
78
units
Participants
title
Self-care - Baseline Cycle 1
categories
measurements
group Id
OG000
spread
0.49
value
0.0
group Id
OG001
spread
0.26
value
0.0
denoms
counts
group Id
OG000
value
136
group Id
OG001
value
45
units
Participants
title
Self-care - Change at Cycle 3

denoms

counts
group Id
OG000
value
252
group Id
OG001
value
126
units
Participants

description

General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.

dispersion Type

Standard Deviation

groups

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
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 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,5L Domain Scores

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Not medical advice