Trial Outcomes & Findings for Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma (NCT NCT03070392)
NCT ID: NCT03070392
Last Updated: 2025-08-01
Results Overview
Overall survival is defined as the time from randomization to date of death due to any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
378 participants
Primary outcome timeframe
From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.
Results posted on
2025-08-01
Participant Flow
A total of 378 patients were randomly assigned (2:1) to Tebentafusp (n=252) or Investigator's Choice (n=126) at 58 sites in 14 countries.
The data cut-off date for this analysis was 13 October 2020. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design.
Participant milestones
| Measure |
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: Dacarbazine
Dacarbazine administered at 1,000 mg/m\^2 of body surface area IV infusion every 3 weeks until confirmed disease progression or unacceptable toxicity.
|
Investigator's Choice: Ipilimumab
Ipilimumab administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments.
|
Investigator's Choice: Pembrolizumab
Pembrolizumab administered at 2 mg/kg IV infusion 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
252
|
7
|
16
|
103
|
|
Overall Study
COMPLETED
|
0
|
0
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
252
|
7
|
6
|
103
|
Reasons for withdrawal
| Measure |
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: Dacarbazine
Dacarbazine administered at 1,000 mg/m\^2 of body surface area IV infusion every 3 weeks until confirmed disease progression or unacceptable toxicity.
|
Investigator's Choice: Ipilimumab
Ipilimumab administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments.
|
Investigator's Choice: Pembrolizumab
Pembrolizumab administered at 2 mg/kg IV infusion 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.
|
|---|---|---|---|---|
|
Overall Study
Not Treated
|
7
|
0
|
3
|
12
|
|
Overall Study
Death
|
3
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
2
|
|
Overall Study
Progressive Disease
|
154
|
6
|
2
|
70
|
|
Overall Study
Adverse Event
|
6
|
1
|
1
|
3
|
|
Overall Study
Alternate anticancer treatment
|
1
|
0
|
0
|
1
|
|
Overall Study
Ongoing
|
73
|
0
|
0
|
11
|
Baseline Characteristics
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Tebentafusp
n=252 Participants
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
n=126 Participants
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.
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
62.1 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
222 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.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.
Overall survival is defined as the time from randomization to date of death due to any cause.
Outcome measures
| Measure |
Tebentafusp
n=252 Participants
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
n=126 Participants
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.
|
|---|---|---|
|
Efficacy: Overall Survival
|
21.7 Months
Interval 18.6 to 28.6
|
16.0 Months
Interval 9.7 to 18.4
|
SECONDARY outcome
Timeframe: Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months.Population: The Safety Analysis Set includes all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. 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.
Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.
Outcome measures
| Measure |
Tebentafusp
n=245 Participants
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
n=111 Participants
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.
|
|---|---|---|
|
Safety: Number of Participants With Treatment Emergent Adverse Events
|
245 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months.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.
Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause.
Outcome measures
| Measure |
Tebentafusp
n=252 Participants
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
n=126 Participants
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.
|
|---|---|---|
|
Efficacy: Progression Free Survival (PFS)
|
3.3 Months
Interval 3.0 to 5.0
|
2.9 Months
Interval 2.8 to 3.0
|
SECONDARY outcome
Timeframe: 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.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.
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.
Outcome measures
| Measure |
Tebentafusp
n=252 Participants
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
n=126 Participants
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.
|
|---|---|---|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 3
|
-0.1 Units on a scale
Standard Deviation 0.66
|
0.1 Units on a scale
Standard Deviation 0.47
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 13
|
0.1 Units on a scale
Standard Deviation 0.52
|
0.1 Units on a scale
Standard Deviation 0.33
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Baseline Cycle 1
|
1.2 Units on a scale
Standard Deviation 0.53
|
1.3 Units on a scale
Standard Deviation 0.55
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 9
|
0.2 Units on a scale
Standard Deviation 0.87
|
0.1 Units on a scale
Standard Deviation 0.53
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 13
|
0.3 Units on a scale
Standard Deviation 0.79
|
0.1 Units on a scale
Standard Deviation 0.60
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 9
|
0.1 Units on a scale
Standard Deviation 0.73
|
-0.1 Units on a scale
Standard Deviation 0.73
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 25
|
0.0 Units on a scale
Standard Deviation 0.53
|
1.0 Units on a scale
Standard Deviation NA
Not calculable due to single participant.
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 17
|
-0.4 Units on a scale
Standard Deviation 0.85
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 21
|
-0.5 Units on a scale
Standard Deviation 0.88
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 25
|
-0.4 Units on a scale
Standard Deviation 0.74
|
0.0 Units on a scale
Standard Deviation NA
Not calculable due to single participant.
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Baseline Cycle 1
|
1.2 Units on a scale
Standard Deviation 0.62
|
1.3 Units on a scale
Standard Deviation 0.55
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 5
|
0.0 Units on a scale
Standard Deviation 0.73
|
0.3 Units on a scale
Standard Deviation 0.65
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 9
|
0.0 Units on a scale
Standard Deviation 0.91
|
0.0 Units on a scale
Standard Deviation 0.55
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 13
|
-0.1 Units on a scale
Standard Deviation 0.60
|
0.3 Units on a scale
Standard Deviation 0.87
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 17
|
0.3 Units on a scale
Standard Deviation 0.57
|
0.2 Units on a scale
Standard Deviation 0.41
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 21
|
0.0 Units on a scale
Standard Deviation 0.58
|
0.5 Units on a scale
Standard Deviation 0.71
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 25
|
0.1 Units on a scale
Standard Deviation 0.64
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at Cycle 29
|
0.0 Units on a scale
Standard Deviation 0.50
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Mobility - Change at EOT
|
0.3 Units on a scale
Standard Deviation 0.73
|
0.4 Units on a scale
Standard Deviation 0.99
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Baseline Cycle 1
|
1.1 Units on a scale
Standard Deviation 0.45
|
1.1 Units on a scale
Standard Deviation 0.29
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 3
|
0.0 Units on a scale
Standard Deviation 0.49
|
0.0 Units on a scale
Standard Deviation 0.26
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 5
|
0.0 Units on a scale
Standard Deviation 0.42
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 9
|
0.0 Units on a scale
Standard Deviation 0.58
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 17
|
0.1 Units on a scale
Standard Deviation 0.68
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 21
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 25
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at Cycle 29
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Self-care - Change at EOT
|
0.1 Units on a scale
Standard Deviation 0.60
|
0.1 Units on a scale
Standard Deviation 0.56
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 3
|
0.2 Units on a scale
Standard Deviation 0.59
|
0.1 Units on a scale
Standard Deviation 0.73
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 5
|
0.1 Units on a scale
Standard Deviation 0.61
|
0.2 Units on a scale
Standard Deviation 0.61
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 17
|
0.5 Units on a scale
Standard Deviation 0.80
|
0.2 Units on a scale
Standard Deviation 0.41
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 21
|
0.3 Units on a scale
Standard Deviation 0.48
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 25
|
0.3 Units on a scale
Standard Deviation 0.46
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at Cycle 29
|
0.2 Units on a scale
Standard Deviation 0.44
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Usual activities - Change at EOT
|
0.4 Units on a scale
Standard Deviation 0.77
|
0.5 Units on a scale
Standard Deviation 0.87
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Baseline Cycle 1
|
1.5 Units on a scale
Standard Deviation 0.71
|
1.5 Units on a scale
Standard Deviation 0.73
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 3
|
0.0 Units on a scale
Standard Deviation 0.75
|
0.1 Units on a scale
Standard Deviation 0.73
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 5
|
0.0 Units on a scale
Standard Deviation 0.65
|
0.2 Units on a scale
Standard Deviation 0.72
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 13
|
0.1 Units on a scale
Standard Deviation 0.51
|
0.1 Units on a scale
Standard Deviation 0.93
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 17
|
0.4 Units on a scale
Standard Deviation 0.85
|
0.3 Units on a scale
Standard Deviation 0.52
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 21
|
0.2 Units on a scale
Standard Deviation 0.55
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at Cycle 29
|
0.1 Units on a scale
Standard Deviation 0.60
|
0.5 Units on a scale
Standard Deviation 0.71
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Pain/Discomfort - Change at EOT
|
0.2 Units on a scale
Standard Deviation 0.87
|
0.4 Units on a scale
Standard Deviation 1.10
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Baseline Cycle 1
|
1.8 Units on a scale
Standard Deviation 0.94
|
1.7 Units on a scale
Standard Deviation 0.89
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 3
|
-0.2 Units on a scale
Standard Deviation 0.77
|
-0.3 Units on a scale
Standard Deviation 0.55
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 5
|
-0.2 Units on a scale
Standard Deviation 0.74
|
0.0 Units on a scale
Standard Deviation 0.61
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 9
|
-0.3 Units on a scale
Standard Deviation 0.80
|
0.1 Units on a scale
Standard Deviation 0.77
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 13
|
-0.4 Units on a scale
Standard Deviation 0.77
|
-0.1 Units on a scale
Standard Deviation 0.60
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at Cycle 29
|
-0.6 Units on a scale
Standard Deviation 0.88
|
0.5 Units on a scale
Standard Deviation 0.71
|
|
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
Anxiety/Depression - Change at EOT
|
0.3 Units on a scale
Standard Deviation 0.94
|
0.2 Units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 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.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.
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.
Outcome measures
| Measure |
Tebentafusp
n=252 Participants
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
n=126 Participants
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.
|
|---|---|---|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 5
|
0.6 Units on a scale
Standard Deviation 15.61
|
-0.7 Units on a scale
Standard Deviation 14.38
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 9
|
-0.9 Units on a scale
Standard Deviation 19.81
|
-3.3 Units on a scale
Standard Deviation 13.30
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Baseline Cycle 1
|
81.0 Units on a scale
Standard Deviation 16.36
|
80.4 Units on a scale
Standard Deviation 18.31
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 3
|
0.4 Units on a scale
Standard Deviation 14.69
|
-0.8 Units on a scale
Standard Deviation 14.28
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 13
|
-2.0 Units on a scale
Standard Deviation 16.48
|
-2.6 Units on a scale
Standard Deviation 8.37
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 17
|
-10.2 Units on a scale
Standard Deviation 20.93
|
-8.5 Units on a scale
Standard Deviation 33.82
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 21
|
-1.8 Units on a scale
Standard Deviation 14.52
|
-1.0 Units on a scale
Standard Deviation 5.66
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 25
|
-13.6 Units on a scale
Standard Deviation 19.43
|
-4.0 Units on a scale
Standard Deviation NA
Not calculable due to single participant
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at Cycle 29
|
0.0 Units on a scale
Standard Deviation 9.25
|
-2.0 Units on a scale
Standard Deviation 1.41
|
|
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
Change at EOT
|
-10.1 Units on a scale
Standard Deviation 22.53
|
-11.7 Units on a scale
Standard Deviation 21.40
|
SECONDARY outcome
Timeframe: 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.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.
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.
Outcome measures
| Measure |
Tebentafusp
n=252 Participants
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
n=126 Participants
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.
|
|---|---|---|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 5
|
-1.152 Units on a scale
Standard Deviation 20.797
|
-10.227 Units on a scale
Standard Deviation 22.557
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 9
|
-2.193 Units on a scale
Standard Deviation 19.577
|
-8.333 Units on a scale
Standard Deviation 13.176
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Baseline Cycle 1
|
76.108 Units on a scale
Standard Deviation 20.233
|
74.872 Units on a scale
Standard Deviation 20.439
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 3
|
0.952 Units on a scale
Standard Deviation 16.274
|
-0.238 Units on a scale
Standard Deviation 14.919
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 13
|
-5.625 Units on a scale
Standard Deviation 17.641
|
-10.185 Units on a scale
Standard Deviation 16.017
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 17
|
-10.185 Units on a scale
Standard Deviation 28.087
|
-4.167 Units on a scale
Standard Deviation 6.972
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 21
|
0.758 Units on a scale
Standard Deviation 18.429
|
-4.167 Units on a scale
Standard Deviation 5.893
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 25
|
-2.381 Units on a scale
Standard Deviation 27.936
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at Cycle 29
|
-8.333 Units on a scale
Standard Deviation 19.720
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Change at EOT
|
-10.417 Units on a scale
Standard Deviation 20.911
|
-10.539 Units on a scale
Standard Deviation 23.148
|
SECONDARY outcome
Timeframe: PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15.Population: The PK Analysis Set included participants in the Safety Analysis Set who had at least 1 measurable PK concentration and who had relevant date, time, and dosing data for the sample.
Serum PK concentrations of tebentafusp were collected over time.
Outcome measures
| Measure |
Tebentafusp
n=231 Participants
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.
|
|---|---|---|
|
Pharmacokinetics (PK): Tebentafusp Concentration
Cycle 1 Day 1 - End of Infusion
|
4201.929 pg/mL
Geometric Coefficient of Variation 0.6
|
—
|
|
Pharmacokinetics (PK): Tebentafusp Concentration
Cycle 1 Day 1 - 12 to 24 hours post-infusion
|
505.100 pg/mL
Geometric Coefficient of Variation 0.7
|
—
|
|
Pharmacokinetics (PK): Tebentafusp Concentration
Cycle 1 Day 8 - End of Infusion
|
5787.139 pg/mL
Geometric Coefficient of Variation 0.4
|
—
|
|
Pharmacokinetics (PK): Tebentafusp Concentration
Cycle 1 Day 8 - 12 to 24 hours post-infusion
|
738.602 pg/mL
Geometric Coefficient of Variation 0.7
|
—
|
|
Pharmacokinetics (PK): Tebentafusp Concentration
Cycle 1 Day 15 - End of Infusion
|
13715.914 pg/mL
Geometric Coefficient of Variation 0.5
|
—
|
|
Pharmacokinetics (PK): Tebentafusp Concentration
Cycle 1 Day 15 - 12 to 24 hours post-infusion
|
1685.354 pg/mL
Geometric Coefficient of Variation 0.6
|
—
|
SECONDARY outcome
Timeframe: ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years.Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years.Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years.Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 5.5 years.Outcome measures
Outcome data not reported
Adverse Events
Tebentafusp
Serious events: 69 serious events
Other events: 245 other events
Deaths: 84 deaths
Investigator's Choice
Serious events: 26 serious events
Other events: 102 other events
Deaths: 57 deaths
Serious adverse events
| Measure |
Tebentafusp
n=245 participants at risk
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
n=111 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Lethargy
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Motor dysfunction
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Presyncope
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Spinal cord compression
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Psychiatric disorders
Mental status changes
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Renal and urinary disorders
Renal failure
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Reproductive system and breast disorders
Scrotal inflammation
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.82%
2/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
6/245 • Number of events 10 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.6%
4/245 • Number of events 13 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Vascular disorders
Hypotension
|
2.0%
5/245 • Number of events 6 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Eye disorders
Diplopia
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Eye disorders
Periorbital edema
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Eye disorders
Uveitis
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.82%
2/245 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
4/245 • Number of events 6 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.82%
2/245 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Asthenia
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Fatigue
|
0.41%
1/245 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Gait disturbance
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
General physical health deterioration
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Pyrexia
|
2.4%
6/245 • Number of events 6 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.41%
1/245 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.82%
2/245 • Number of events 18 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.82%
2/245 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 5 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hypertransaminasemia
|
0.41%
1/245 • Number of events 5 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Immune system disorders
Cytokine release syndrome
|
9.8%
24/245 • Number of events 51 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Appendicitis
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
COVID-19
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Erysipelas
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Salmonella sepsis
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Amylase increased
|
0.41%
1/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Aspartate aminotransferase increased
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Blood creatinine increased
|
0.82%
2/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Lipase increased
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.82%
2/245 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Brain edema
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Dizziness
|
0.41%
1/245 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/245 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
Other adverse events
| Measure |
Tebentafusp
n=245 participants at risk
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
n=111 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
24/245 • Number of events 36 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Dizziness
|
10.6%
26/245 • Number of events 46 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
8.1%
9/111 • Number of events 12 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
10.2%
25/245 • Number of events 62 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
3.6%
4/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.8%
24/245 • Number of events 51 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
5/245 • Number of events 7 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
5.4%
6/111 • Number of events 10 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Cardiac disorders
Tachycardia
|
9.8%
24/245 • Number of events 45 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Endocrine disorders
Hyperthyroidism
|
0.82%
2/245 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
11.7%
13/111 • Number of events 16 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
3/245 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
10.8%
12/111 • Number of events 15 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Eye disorders
Periorbital edema
|
10.6%
26/245 • Number of events 51 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.1%
59/245 • Number of events 92 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
12.6%
14/111 • Number of events 21 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.4%
50/245 • Number of events 79 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
12.6%
14/111 • Number of events 21 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Constipation
|
18.0%
44/245 • Number of events 65 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
11.7%
13/111 • Number of events 15 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
24.9%
61/245 • Number of events 120 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
19.8%
22/111 • Number of events 45 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
8/245 • Number of events 9 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
5.4%
6/111 • Number of events 6 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
20/245 • Number of events 28 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
4.5%
5/111 • Number of events 5 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Nausea
|
48.6%
119/245 • Number of events 288 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
25.2%
28/111 • Number of events 44 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
29.8%
73/245 • Number of events 163 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
9.0%
10/111 • Number of events 19 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Asthenia
|
15.5%
38/245 • Number of events 71 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
8.1%
9/111 • Number of events 11 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Chills
|
47.8%
117/245 • Number of events 378 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
3.6%
4/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Face edema
|
10.2%
25/245 • Number of events 39 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Fatigue
|
50.6%
124/245 • Number of events 352 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
35.1%
39/111 • Number of events 53 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Influenza like illness
|
7.3%
18/245 • Number of events 75 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Edema peripheral
|
26.9%
66/245 • Number of events 119 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
General disorders
Pyrexia
|
75.9%
186/245 • Number of events 682 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
6.3%
7/111 • Number of events 11 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatic pain
|
6.1%
15/245 • Number of events 41 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
3.6%
4/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
10.6%
26/245 • Number of events 56 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
5.4%
6/111 • Number of events 6 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Immune system disorders
Cytokine release syndrome
|
13.9%
34/245 • Number of events 91 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
20/245 • Number of events 24 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
14/245 • Number of events 19 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
4.5%
5/111 • Number of events 5 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
20.4%
50/245 • Number of events 127 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
10.8%
12/111 • Number of events 19 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Aspartate aminotransferase increased
|
22.4%
55/245 • Number of events 134 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
9.9%
11/111 • Number of events 19 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.4%
23/245 • Number of events 60 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Blood creatinine increased
|
5.3%
13/245 • Number of events 26 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
13/245 • Number of events 20 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 8 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Lipase increased
|
14.3%
35/245 • Number of events 73 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
6.3%
7/111 • Number of events 12 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Investigations
Weight decreased
|
6.5%
16/245 • Number of events 16 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
6.3%
7/111 • Number of events 11 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.4%
45/245 • Number of events 56 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
13.5%
15/111 • Number of events 17 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.3%
18/245 • Number of events 24 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 3 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.8%
19/245 • Number of events 31 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.0%
27/245 • Number of events 52 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 5 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.6%
53/245 • Number of events 97 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
16.2%
18/111 • Number of events 30 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.4%
45/245 • Number of events 56 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
8.1%
9/111 • Number of events 14 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
14/245 • Number of events 30 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
24/245 • Number of events 40 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
6.3%
7/111 • Number of events 9 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Headache
|
30.6%
75/245 • Number of events 135 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
9.9%
11/111 • Number of events 15 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Nervous system disorders
Parasthesia
|
11.0%
27/245 • Number of events 53 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Psychiatric disorders
Anxiety
|
5.3%
13/245 • Number of events 14 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Psychiatric disorders
Insomnia
|
9.0%
22/245 • Number of events 24 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
5.4%
6/111 • Number of events 6 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
44/245 • Number of events 67 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
9.9%
11/111 • Number of events 12 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.7%
31/245 • Number of events 42 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
6.3%
7/111 • Number of events 7 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
16/245 • Number of events 20 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
21/245 • Number of events 22 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.4%
77/245 • Number of events 106 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
3.6%
4/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
24.5%
60/245 • Number of events 120 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
19.6%
48/245 • Number of events 62 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.00%
0/111 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
13/245 • Number of events 17 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 1 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
68.6%
168/245 • Number of events 536 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
23.4%
26/111 • Number of events 33 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
53.9%
132/245 • Number of events 603 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
16.2%
18/111 • Number of events 25 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.6%
75/245 • Number of events 343 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
8.1%
9/111 • Number of events 10 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
20.8%
51/245 • Number of events 80 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.8%
19/245 • Number of events 24 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
9.0%
22/245 • Number of events 26 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
1.8%
2/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
16.3%
40/245 • Number of events 45 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
3.6%
4/111 • Number of events 5 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Vascular disorders
Flushing
|
10.2%
25/245 • Number of events 34 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
0.90%
1/111 • Number of events 2 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Vascular disorders
Hypertension
|
15.5%
38/245 • Number of events 91 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
7.2%
8/111 • Number of events 8 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
|
Vascular disorders
Hypotension
|
37.1%
91/245 • Number of events 212 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
2.7%
3/111 • Number of events 4 • Approximately 36 months.
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place