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NCT03837899 · OUTCOME

Dose-Expansion Phase Only: Overall Survival (OS)

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
months
Interval / dispersion
Inter-Quartile Range
Time frame
From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

What was measured

OS was defined as the time from the date of first dose of study treatment until death due to any cause regardless of whether the patient withdraws from study treatment or received another anti-cancer therapy (i.e date of death or censoring - date of first dose + 1).

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

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 months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg6.6Not reported2.215.8Not reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg6.9Not reported3.2NANA indicates higher inter-quartile range not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        15.8
        value
        6.6
      2. comment
        NA indicates higher inter-quartile range not reached.
        group Id
        OG001
        lower Limit
        3.2
        upper Limit
        NA
        value
        6.9
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      10
    units
    Participants
description
OS was defined as the time from the date of first dose of study treatment until death due to any cause regardless of whether the patient withdraws from study treatment or received another anti-cancer therapy (i.e date of death or censoring - date of first dose + 1).
dispersion Type
Inter-Quartile 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 FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
title
Dose-Expansion Phase Only: Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice