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NCT03837899 · OUTCOME

Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab

Durvalumab and Tremelimumab for Pediatric Malignancies · Source last updated 2026-07-07

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

Measure
GEOMETRIC_MEAN
Unit
(mcg/mL)/(mg/kg)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

What was measured

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Analysis population: The PK analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis.

Groups in this outcome

Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg7
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg11
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg3
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg8

Reported measurements

Source class 1
Values in (mcg/mL)/(mg/kg) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg18.158.0Not reportedNot reportedNot reported
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg28.836.0Not reportedNot reportedNot reported
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg13.7135Not reportedNot reportedNot reported
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg20.434.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.0
        value
        18.1
      2. group Id
        OG001
        spread
        36.0
        value
        28.8
      3. group Id
        OG002
        spread
        135
        value
        13.7
      4. group Id
        OG003
        spread
        34.2
        value
        20.4
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG000
    title
    Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
  2. description
    Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG001
    title
    Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
  3. description
    Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG002
    title
    Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
  4. description
    Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG003
    title
    Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
param Type
GEOMETRIC_MEAN
population Description
The PK analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis.
reporting Status
POSTED
time Frame
Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12
title
Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab
type
PRIMARY
unit Of Measure
(mcg/mL)/(mg/kg)

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Preserved source evidence · Not medical advice