Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NCT03732677 · tracked via the Priya Life Science USA tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2018-11-16

Last updated

2026-07-17

Condition(s) studied

Muscle Invasive Bladder Cancer

Investigational drug(s) / intervention(s)

DurvalumabCisplatinGemcitabine

Durvalumab: Anti- PD-L1 Antibody

Cisplatin: Chemotherapy Agent

Gemcitabine: Chemotherapy agent

Study summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Eligibility

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

Inclusion: * Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology * Patients must be planning to undergo a radical cystectomy * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC * ECOG performance status of 0 or 1 * Must have a life expectancy of at least 12 weeks at randomization Exclusion: * Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening. * Prior pelvic radiotherapy treatment within 2 years of randomization to study * Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin \[BCG\]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies. * Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. * Uncontrolled intercurrent illness * Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

Primary outcome measure(s)

Pathologic Complete Response (pCR) Rates at Time of Cystectomy — Up to 6 months
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.
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event — Up to 48 months
EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first

Trial sites (188)

Facility	City	Region
Research Site	Birmingham	Alabama
Research Site	Los Angeles	California
Research Site	Palo Alto	California
Research Site	New Haven	Connecticut
Research Site	Chicago	Illinois
Research Site	Geneva	Illinois
Research Site	Iowa City	Iowa
Research Site	Westwood	Kansas
Research Site	Louisville	Kentucky
Research Site	New Orleans	Louisiana
Research Site	Towson	Maryland
Research Site	Ann Arbor	Michigan
Research Site	Detroit	Michigan
Research Site	New York	New York
Research Site	Rochester	New York
Research Site	Bethlehem	Pennsylvania
Research Site	Burlington	Vermont
Research Site	Milwaukee	Wisconsin
Research Site	Brisbane	Australia
Research Site	Elizabeth Vale	Australia
Research Site	Macquarie University	Australia
Research Site	Melbourne	Australia
Research Site	Murdoch	Australia
Research Site	South Brisbane	Australia
Research Site	Bruges	Belgium
Research Site	Charleroi	Belgium
Research Site	Kortrijk	Belgium
Research Site	Leuven	Belgium
Research Site	Liège	Belgium
Research Site	Roeselare	Belgium
Research Site	Barretos	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Rio de Janeiro	Brazil
Research Site	Santa Maria	Brazil
Research Site	São José do Rio Preto	Brazil
Research Site	São Paulo	Brazil
Research Site	São Paulo	Brazil

+ 148 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Other trials for the same condition

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin Active, not recruiting

Sample Collection for Ongoing Research and Product Evaluation Study Recruiting

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03732677 on ClinicalTrials.gov ↗ ← All trials in the USA