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NCT03837899 · OUTCOME

Number of Participants With Individual Antibody Titer Measurement

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
Pre-infusion on Cycle 1 Day 1 and Cycle 4 Day 1 for durvalumab, pre-infusion on Cycle 1 Day 1, pre-infusion on Cycle 3, 4, and 8 Day 1 for tremelimumab (dose-expansion)

What was measured

Blood samples were planned to be collected for vaccine antibody titer measurements before and after planned routine immunization.

Analysis population: Participants who has a baseline titer collected and who has subsequent samples following a routine childhood immunization were included. As no participants received a routine immunization during the study, no additional samples were collected, hence no data analysed.

Groups in this outcome

Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

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
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg7
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg11
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg3
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg8
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg11
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      11
    6. group Id
      OG005
      value
      10
    units
    Participants
description
Blood samples were planned to be collected for vaccine antibody titer measurements before and after planned routine immunization.
groups
  1. description
    Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 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
    Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
  2. description
    Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG001
    title
    Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
  3. description
    Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG002
    title
    Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
  4. description
    Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
    id
    OG003
    title
    Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
  5. 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
    OG004
    title
    SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
  6. 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
    OG005
    title
    STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who has a baseline titer collected and who has subsequent samples following a routine childhood immunization were included. As no participants received a routine immunization during the study, no additional samples were collected, hence no data analysed.
reporting Status
POSTED
time Frame
Pre-infusion on Cycle 1 Day 1 and Cycle 4 Day 1 for durvalumab, pre-infusion on Cycle 1 Day 1, pre-infusion on Cycle 3, 4, and 8 Day 1 for tremelimumab (dose-expansion)
title
Number of Participants With Individual Antibody Titer Measurement
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice