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NCT03070392 · OUTCOME

Pharmacokinetics (PK): Tebentafusp Concentration

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

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

Measure
GEOMETRIC_MEAN
Unit
pg/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
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.

What was measured

Serum PK concentrations of tebentafusp were collected over time.

Analysis 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.

Groups in this outcome

Tebentafusp

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Tebentafusp231

Reported measurements

Cycle 1 Day 1 - End of Infusion

Analysis denominator · Participants

GroupSource count
Tebentafusp207
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tebentafusp4201.9290.6Not reportedNot reportedNot reported
Cycle 1 Day 1 - 12 to 24 hours post-infusion

Analysis denominator · Participants

GroupSource count
Tebentafusp212
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tebentafusp505.1000.7Not reportedNot reportedNot reported
Cycle 1 Day 8 - End of Infusion

Analysis denominator · Participants

GroupSource count
Tebentafusp200
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tebentafusp5787.1390.4Not reportedNot reportedNot reported
Cycle 1 Day 8 - 12 to 24 hours post-infusion

Analysis denominator · Participants

GroupSource count
Tebentafusp198
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tebentafusp738.6020.7Not reportedNot reportedNot reported
Cycle 1 Day 15 - End of Infusion

Analysis denominator · Participants

GroupSource count
Tebentafusp202
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tebentafusp13715.9140.5Not reportedNot reportedNot reported
Cycle 1 Day 15 - 12 to 24 hours post-infusion

Analysis denominator · Participants

GroupSource count
Tebentafusp205
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tebentafusp1685.3540.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.6
        value
        4201.929
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      units
      Participants
    title
    Cycle 1 Day 1 - End of Infusion
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.7
        value
        505.100
    denoms
    1. counts
      1. group Id
        OG000
        value
        212
      units
      Participants
    title
    Cycle 1 Day 1 - 12 to 24 hours post-infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.4
        value
        5787.139
    denoms
    1. counts
      1. group Id
        OG000
        value
        200
      units
      Participants
    title
    Cycle 1 Day 8 - End of Infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.7
        value
        738.602
    denoms
    1. counts
      1. group Id
        OG000
        value
        198
      units
      Participants
    title
    Cycle 1 Day 8 - 12 to 24 hours post-infusion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.5
        value
        13715.914
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      units
      Participants
    title
    Cycle 1 Day 15 - End of Infusion
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.6
        value
        1685.354
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      units
      Participants
    title
    Cycle 1 Day 15 - 12 to 24 hours post-infusion
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    units
    Participants
description
Serum PK concentrations of tebentafusp were collected over time.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
    id
    OG000
    title
    Tebentafusp
param Type
GEOMETRIC_MEAN
population Description
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.
reporting Status
POSTED
time Frame
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.
title
Pharmacokinetics (PK): Tebentafusp Concentration
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice