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NCT02516241 · OUTCOME

Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (01NOV2017, a maximum of 3 years).

What was measured

Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. unconfirmed responses are excluded.

Analysis population: Durvalumab Cisplatin Ineligible Population include all patients who had received D monotherapy and were not eligible for cisplatin treatment at baseline (per eCRF).

Groups in this outcome

Monotherapy - PD-L1 High

MEDI4736 (Durvalumab) - PD-L1 high

Monotherapy - PD-L1 Low/Negative

MEDI4736 (Durvalumab) - PD-L1 low/negative

Monotherapy - Total

MEDI4736 (Durvalumab)

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

Analysis denominator · Participants

GroupSource count
Monotherapy - PD-L1 High87
Monotherapy - PD-L1 Low/Negative56
Monotherapy - Total143

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Monotherapy - PD-L1 High23.0Not reportedNot reportedNot reportedNot reported
Monotherapy - PD-L1 Low/Negative17.9Not reportedNot reportedNot reportedNot reported
Monotherapy - Total21.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23.0
      2. group Id
        OG001
        value
        17.9
      3. group Id
        OG002
        value
        21.0
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    2. group Id
      OG001
      value
      56
    3. group Id
      OG002
      value
      143
    units
    Participants
description
Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. unconfirmed responses are excluded.
groups
  1. description
    MEDI4736 (Durvalumab) - PD-L1 high
    id
    OG000
    title
    Monotherapy - PD-L1 High
  2. description
    MEDI4736 (Durvalumab) - PD-L1 low/negative
    id
    OG001
    title
    Monotherapy - PD-L1 Low/Negative
  3. description
    MEDI4736 (Durvalumab)
    id
    OG002
    title
    Monotherapy - Total
param Type
NUMBER
population Description
Durvalumab Cisplatin Ineligible Population include all patients who had received D monotherapy and were not eligible for cisplatin treatment at baseline (per eCRF).
reporting Status
POSTED
time Frame
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (01NOV2017, a maximum of 3 years).
title
Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice