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Clinical Trials in Turkey / NCT03732677
Active, not recruiting Phase 3

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

NCT03732677 · tracked via the Priya Life Science Turkey 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)

Durvalumab →Cisplatin →Gemcitabine →

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
No
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)

FacilityCityRegionStatus
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 →

More AstraZeneca trials in Turkey

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer Active, not recruiting
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors Recruiting
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) Recruiting

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
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 Turkey