NCT03837899 · OUTCOME

Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months

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: NUMBER
Unit: percentage of participants
Interval / dispersion: 90% Confidence Interval
Time frame: At 12 and 24 Weeks

What was measured

Survival rates were defined as the Kaplan-Meier estimate of OS at 12 and 24 months.

Analysis population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

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

12 Months

Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	25.6	Not reported	6.27	51.10	Not reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	40.0	Not reported	15.94	63.31	Not reported

24 Months

Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	NA	Not reported	NA	NA	NA indicated survival rate not reached for 24 months at this DCO.
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	30.0	Not reported	9.74	53.67	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
6.27
upper Limit
51.10
value
25.6
group Id
OG001
lower Limit
15.94
upper Limit
63.31
value
40.0
title
12 Months
categories
measurements
comment
NA indicated survival rate not reached for 24 months at this DCO.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
9.74
upper Limit
53.67
value
30.0
title
24 Months

denoms

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

description

Survival rates were defined as the Kaplan-Meier estimate of OS at 12 and 24 months.

dispersion Type

90% Confidence Interval

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

NUMBER

population Description

The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

reporting Status

POSTED

time Frame

At 12 and 24 Weeks

title

Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice