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NCT03298451 · OUTCOME

Summary of Durvalumab Concentration Over Time

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2026-07-27

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).

What was measured

Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.

Analysis population: PK analysis set includes all participants who received at least 1 dose Durvalumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.

Groups in this outcome

Durva 1500 mg

Durvalumab 1500 mg every 4 weeks (Q4W)

Treme 300 mg x1 Dose + Durva 1500 mg

Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W

Treme 75 mg x4 Doses + Durva 1500 mg

Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W

Sora 400 mg

Sorafenib 400 mg twice daily (BID)

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

Analysis denominator · Participants

GroupSource count
Durva 1500 mg357
Treme 300 mg x1 Dose + Durva 1500 mg388
Treme 75 mg x4 Doses + Durva 1500 mg142
Sora 400 mg0

Reported measurements

Cycle 2 (Week 4) pre-dose, Geometric mean

Analysis denominator · Participants

GroupSource count
Durva 1500 mg340
Treme 300 mg x1 Dose + Durva 1500 mg314
Treme 75 mg x4 Doses + Durva 1500 mg142
Sora 400 mg0
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durva 1500 mg74.786.7Not reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg59.9101.6Not reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg65.168.4Not reportedNot reportedNot reported
Cycle 4 (Week 12) pre-dose, Geometric mean

Analysis denominator · Participants

GroupSource count
Durva 1500 mg252
Treme 300 mg x1 Dose + Durva 1500 mg253
Treme 75 mg x4 Doses + Durva 1500 mg142
Sora 400 mg0
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durva 1500 mg113.9116.2Not reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg77.5280.1Not reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg92.1137.5Not reportedNot reportedNot reported
Cycle 4 (Week 12) post-dose, Geometric mean

Analysis denominator · Participants

GroupSource count
Durva 1500 mg255
Treme 300 mg x1 Dose + Durva 1500 mg248
Treme 75 mg x4 Doses + Durva 1500 mg142
Sora 400 mg0
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durva 1500 mg556.932.7Not reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg539.338.6Not reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg528.436.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        86.7
        value
        74.7
      2. group Id
        OG001
        spread
        101.6
        value
        59.9
      3. group Id
        OG002
        spread
        68.4
        value
        65.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        340
      2. group Id
        OG001
        value
        314
      3. group Id
        OG002
        value
        142
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    Cycle 2 (Week 4) pre-dose, Geometric mean
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        116.2
        value
        113.9
      2. group Id
        OG001
        spread
        280.1
        value
        77.5
      3. group Id
        OG002
        spread
        137.5
        value
        92.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        252
      2. group Id
        OG001
        value
        253
      3. group Id
        OG002
        value
        142
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    Cycle 4 (Week 12) pre-dose, Geometric mean
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.7
        value
        556.9
      2. group Id
        OG001
        spread
        38.6
        value
        539.3
      3. group Id
        OG002
        spread
        36.8
        value
        528.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        255
      2. group Id
        OG001
        value
        248
      3. group Id
        OG002
        value
        142
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    Cycle 4 (Week 12) post-dose, Geometric mean
denoms
  1. counts
    1. group Id
      OG000
      value
      357
    2. group Id
      OG001
      value
      388
    3. group Id
      OG002
      value
      142
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Durvalumab 1500 mg every 4 weeks (Q4W)
    id
    OG000
    title
    Durva 1500 mg
  2. description
    Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W
    id
    OG001
    title
    Treme 300 mg x1 Dose + Durva 1500 mg
  3. description
    Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W
    id
    OG002
    title
    Treme 75 mg x4 Doses + Durva 1500 mg
  4. description
    Sorafenib 400 mg twice daily (BID)
    id
    OG003
    title
    Sora 400 mg
param Type
GEOMETRIC_MEAN
population Description
PK analysis set includes all participants who received at least 1 dose Durvalumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.
reporting Status
POSTED
time Frame
To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).
title
Summary of Durvalumab Concentration Over Time
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice