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NCT03298451 · OUTCOME

Presence of ADA for Durvalumab

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2026-07-27

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
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

What was measured

Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.

Analysis population: The Durvalumab ADA evaluable set includes all participants who received at least 1 dose of Durvalumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Durvalumab. T75+D arm was closed during study.

Groups in this outcome

Durva 1500 mg

Durvalumab 1500 mg every 4 weeks (Q4W)

Treme 300 mg x1 Dose + Durva 1500 mg

Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W

Treme 75 mg x4 Doses + Durva 1500 mg

Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W

Sora 400 mg

Sorafenib 400 mg twice daily (BID)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Durva 1500 mg282
Treme 300 mg x1 Dose + Durva 1500 mg294
Treme 75 mg x4 Doses + Durva 1500 mg108
Sora 400 mg0

Reported measurements

Treatment-emergent ADA positive (ADA Incidence)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Durva 1500 mg8Not reportedNot reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg9Not reportedNot reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg5Not reportedNot reportedNot reportedNot reported
Treatment-induced ADA (Positive Post-baseline only)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Durva 1500 mg7Not reportedNot reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg9Not reportedNot reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        5
    title
    Treatment-emergent ADA positive (ADA Incidence)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        5
    title
    Treatment-induced ADA (Positive Post-baseline only)
denoms
  1. counts
    1. group Id
      OG000
      value
      282
    2. group Id
      OG001
      value
      294
    3. group Id
      OG002
      value
      108
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.
groups
  1. description
    Durvalumab 1500 mg every 4 weeks (Q4W)
    id
    OG000
    title
    Durva 1500 mg
  2. description
    Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W
    id
    OG001
    title
    Treme 300 mg x1 Dose + Durva 1500 mg
  3. description
    Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W
    id
    OG002
    title
    Treme 75 mg x4 Doses + Durva 1500 mg
  4. description
    Sorafenib 400 mg twice daily (BID)
    id
    OG003
    title
    Sora 400 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
The Durvalumab ADA evaluable set includes all participants who received at least 1 dose of Durvalumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Durvalumab. T75+D arm was closed during study.
reporting Status
POSTED
time Frame
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
title
Presence of ADA for Durvalumab
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice