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NCT03837899 · OUTCOME

Dose-Expansion Phase Only: Best Objective Response (BOR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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

BOR was calculated based on the overall visit responses from each RECIST 1.1 assessment. Categorization of BOR for solid tumors were based on RECIST 1.1 using the following response categories: CR, PR, stable disease (SD), progression of disease (PD), and not evaluable (NE). CR: disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to \<10 mm. PR: 30% decrease in the sum of diameters of TLs. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD. PD: \>= 20 % increase in the sum of diameters to TLs and an increase of \>= 5 mm. NE: Only relevant if any of the TLs were not assessed or NE or had a lesion intervention at visit. Non-CR/Non-PD: Persistence of 1+ non-target lesion (s). Non-CR/non-PD was relevant to participants who did not have measurable disease at baseline.

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

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg1Not reportedNot reportedNot reportedNot reported
Unconfirmed complete or partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
SD >= 7 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg1Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg1Not reportedNot reportedNot reportedNot reported
PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg9Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg7Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg1Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Unconfirmed complete or partial response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    SD >= 7 weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
    title
    PD
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      10
    units
    Participants
description
BOR was calculated based on the overall visit responses from each RECIST 1.1 assessment. Categorization of BOR for solid tumors were based on RECIST 1.1 using the following response categories: CR, PR, stable disease (SD), progression of disease (PD), and not evaluable (NE). CR: disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to \<10 mm. PR: 30% decrease in the sum of diameters of TLs. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD. PD: \>= 20 % increase in the sum of diameters to TLs and an increase of \>= 5 mm. NE: Only relevant if any of the TLs were not assessed or NE or had a lesion intervention at visit. Non-CR/Non-PD: Persistence of 1+ non-target lesion (s). Non-CR/non-PD was relevant to participants who did not have measurable disease at baseline.
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
COUNT_OF_PARTICIPANTS
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: Best Objective Response (BOR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice