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NCT03837899 · OUTCOME

Dose-Expansion Phase: Tmax 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
MEDIAN
Unit
days
Interval / dispersion
Full Range
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, 8, and 12

What was measured

Serum samples were collected from the participants at the defined timepoints. Tmax 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

SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came 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
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg11
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg10

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0.049Not reported0.040.09Not reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0.051Not reported0.040.08Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.04
        upper Limit
        0.09
        value
        0.049
      2. group Id
        OG001
        lower Limit
        0.04
        upper Limit
        0.08
        value
        0.051
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.
dispersion Type
Full Range
groups
  1. description
    Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 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
    SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
  2. description
    Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
    id
    OG001
    title
    STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
param Type
MEDIAN
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, 8, and 12
title
Dose-Expansion Phase: Tmax of Durvalumab
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice