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NCT03732677 · OUTCOME

Pathologic Complete Response (pCR) Rates at Time of Cystectomy

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17

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
Up to 6 months

What was measured

pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.

Analysis population: Full Analysis Set (Intention to Treat): includes all randomized subjects

Groups in this outcome

Durvalumab + Gemcitabine + Cisplatin

Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Gemcitabine + Cisplatin

Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

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

Analysis denominator · Participants

GroupSource count
Durvalumab + Gemcitabine + Cisplatin533
Gemcitabine + Cisplatin530

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Durvalumab + Gemcitabine + Cisplatin199Not reportedNot reportedNot reportedNot reported
Gemcitabine + Cisplatin146Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.227
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.084
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0005
    param Type
    Odds Ratio (OR)
    param Value
    1.60
    statistical Comment
    Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    1.227
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.084
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0005
    param Type
    Odds Ratio (OR)
    param Value
    1.60
    statistical Comment
    Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        199
      2. group Id
        OG001
        value
        146
denoms
  1. counts
    1. group Id
      OG000
      value
      533
    2. group Id
      OG001
      value
      530
    units
    Participants
description
pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.
groups
  1. description
    Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    OG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    OG001
    title
    Gemcitabine + Cisplatin
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (Intention to Treat): includes all randomized subjects
reporting Status
POSTED
time Frame
Up to 6 months
title
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice