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← Intraocular (Uveal) Melanoma

NCT03070392 · STUDY IN CONTEXT

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Overall survival is defined as the time from randomization to date of death due to any cause.

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.

→

secondary · POSTED

Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

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

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03070392
qol key
qol-0003
source section id
NCT03070392-om-0003
source outcome index
3
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
measure definition
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.
time frame
EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03070392
qol key
qol-0004
source section id
NCT03070392-om-0004
source outcome index
4
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
measure definition
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.
time frame
EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03070392
qol key
qol-0005
source section id
NCT03070392-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
measure definition
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.
time frame
EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating better
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03070392
trial label
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0000
    source section id
    NCT03070392-om-0000
    source outcome index
    0
    endpoint
    Efficacy: Overall Survival
    endpoint definition
    Overall survival is defined as the time from randomization to date of death due to any cause.
    time origin
    From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0001
    source section id
    NCT03070392-om-0001
    source outcome index
    1
    endpoint
    Safety: Number of Participants With Treatment Emergent Adverse Events
    endpoint definition
    Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.
    time origin
    Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0002
    source section id
    NCT03070392-om-0002
    source outcome index
    2
    endpoint
    Efficacy: Progression Free Survival (PFS)
    endpoint definition
    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.
    time origin
    PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0003
    source section id
    NCT03070392-om-0003
    source outcome index
    3
    endpoint
    Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
    endpoint definition
    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.
    time origin
    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.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0004
    source section id
    NCT03070392-om-0004
    source outcome index
    4
    endpoint
    Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
    endpoint definition
    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.
    time origin
    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.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0005
    source section id
    NCT03070392-om-0005
    source outcome index
    5
    endpoint
    Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
    endpoint definition
    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.
    time origin
    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.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Tebentafusp
    regimen
    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.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Investigator's Choice
    regimen
    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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Tebentafusp
    regimen
    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.
    analyzed count
    245
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Investigator's Choice
    regimen
    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.
    analyzed count
    111
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Tebentafusp
    regimen
    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.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Investigator's Choice
    regimen
    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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Tebentafusp
    regimen
    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.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Investigator's Choice
    regimen
    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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Tebentafusp
    regimen
    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.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Investigator's Choice
    regimen
    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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Tebentafusp
    regimen
    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.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Investigator's Choice
    regimen
    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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03070392-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    harm key
    EG000
    source section id
    NCT03070392-ae
    event group key
    EG000
    event group label
    Tebentafusp
    serious affected
    69
    serious at risk
    245
    other affected
    245
    other at risk
    245
    frequency threshold
    5
    collection period
    Approximately 36 months.
    event definition
    The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    harm key
    EG001
    source section id
    NCT03070392-ae
    event group key
    EG001
    event group label
    Investigator's Choice
    serious affected
    26
    serious at risk
    111
    other affected
    102
    other at risk
    111
    frequency threshold
    5
    collection period
    Approximately 36 months.
    event definition
    The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    qol key
    qol-0003
    source section id
    NCT03070392-om-0003
    source outcome index
    3
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
    measure definition
    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.
    time frame
    EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    qol key
    qol-0004
    source section id
    NCT03070392-om-0004
    source outcome index
    4
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
    measure definition
    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.
    time frame
    EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-intraocular-uveal-melanoma
    nct id
    NCT03070392
    qol key
    qol-0005
    source section id
    NCT03070392-om-0005
    source outcome index
    5
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
    measure definition
    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.
    time frame
    EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating better
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice