NCT03837899 · OUTCOME

Dose-Expansion Phase: Cmax 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
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, 8, and 12

What was measured

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

Group	Source count
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	11
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	10

Reported measurements

Source class 1

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	606	27.7	Not reported	Not reported	Not reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	595	14.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
27.7
value
606
group Id
OG001
spread
14.2
value
595

denoms

counts
group Id
OG000
value
11
group Id
OG001
value
10
units
Participants

description

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

dispersion Type

Geometric Coefficient of Variation

groups

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
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

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, 8, and 12

title

Dose-Expansion Phase: Cmax of Durvalumab

type

SECONDARY

unit Of Measure

mcg/mL

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

Preserved source evidence · Not medical advice