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Comparison · NCT03732677-94bab337

Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: Pathologic Complete Response (pCR) Rates at Time of Cystectomy

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: Pathologic Complete Response (pCR) Rates at Time of Cystectomy. Trial comparisons, record NCT03732677-94bab337. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03732677-94bab337

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3730.3330.415wilson
Risk in group 20.2750.2390.315wilson
Risk difference, group 1 minus group 20.09790.04160.153newcombe hybrid score
Risk ratio, group 1 over group 21.361.141.62log
Odds ratio, group 1 over group 21.571.212.03log
Number needed to treat, for one more participant with the outcome on Durvalumab + Gemcitabine + Cisplatin than on Gemcitabine + Cisplatin10.26.5224from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Durvalumab + 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
199533OG000
Group 2Gemcitabine + 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
146530OG001

Outcome

Type
PRIMARY
Title
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
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.
Time frame
Up to 6 months
Population
Full Analysis Set (Intention to Treat): includes all randomized subjects

Source ClinicalTrials.gov

Trial

Title
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
NCT number
NCT03732677
Phases
PHASE3
Conditions
Muscle Invasive Bladder Cancer
Interventions
Durvalumab, Cisplatin, Gemcitabine
Lead sponsor
AstraZeneca
Results first posted
2025-07-03

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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