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NCT02516241 · OUTCOME

Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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
At week 0, 4, 12 and at follow-up Month 3.

What was measured

Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.

Analysis population: ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result

Groups in this outcome

Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

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

Analysis denominator · Participants

GroupSource count
Combination Therapy340

Reported measurements

ADA evaluable patients

Analysis denominator · Participants

GroupSource count
Combination Therapy340
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy292Not reportedNot reportedNot reportedNot reported
ADA positive at any visit (ADA Prevalence)

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy64Not reportedNot reportedNot reportedNot reported
Treatment-emergent ADA positive (ADA Incidence)

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy54Not reportedNot reportedNot reportedNot reported
Treatment-boosted ADA

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy1Not reportedNot reportedNot reportedNot reported
Treatment-induced ADA (Positive Post-baseline only)

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy53Not reportedNot reportedNot reportedNot reported
ADA Positive at Baseline only

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy8Not reportedNot reportedNot reportedNot reported
ADA Positive Post-baseline and Positive at Baseline

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy3Not reportedNot reportedNot reportedNot reported
Persistently Positive

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy31Not reportedNot reportedNot reportedNot reported
Transiently Positive

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy25Not reportedNot reportedNot reportedNot reported
nAb Positive at any visit

Analysis denominator · Participants

GroupSource count
Combination Therapy292
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy50Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        292
    denoms
    1. counts
      1. group Id
        OG000
        value
        340
      units
      Participants
    title
    ADA evaluable patients
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    ADA positive at any visit (ADA Prevalence)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        54
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    Treatment-emergent ADA positive (ADA Incidence)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    Treatment-boosted ADA
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        53
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    Treatment-induced ADA (Positive Post-baseline only)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    ADA Positive at Baseline only
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    ADA Positive Post-baseline and Positive at Baseline
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    Persistently Positive
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    Transiently Positive
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        50
    denoms
    1. counts
      1. group Id
        OG000
        value
        292
      units
      Participants
    title
    nAb Positive at any visit
denoms
  1. counts
    1. group Id
      OG000
      value
      340
    units
    Participants
description
Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    OG000
    title
    Combination Therapy
param Type
COUNT_OF_PARTICIPANTS
population Description
ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result
reporting Status
POSTED
time Frame
At week 0, 4, 12 and at follow-up Month 3.
title
Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice