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Clinical Trials in the USA / NCT03682068
Active, not recruiting Phase 3

Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

NCT03682068 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2018-09-27
Last updated
2026-08-20

Condition(s) studied

Unresectable Locally Advanced Urothelial CancerMetastatic Urothelial Cancer

Investigational drug(s) / intervention(s)

DurvalumabTremelimumabCisplatin + GemcitabineCarboplatin + Gemcitabine

Durvalumab: Durvalumab IV (intravenous infusion)

Tremelimumab: Tremelimumab IV (intravenous infusion)

Cisplatin + Gemcitabine: Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Carboplatin + Gemcitabine: Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Study summary

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Key Inclusion Criteria: * Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) * Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred \>12 months from the last therapy \[for chemoradiation and adjuvant treatment\] or \>12 months from the last surgery \[for neoadjuvant treatment\]. * At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment * Adequate organ and marrow function as defined in the protocol * Life expectancy ≥12 weeks in the opinion of the investigator * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Key Exclusion Criteria: * Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment. * No severe concomitant condition that requires immunosuppression medication * Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * Patients who may be eligible for or are being considered for radical resection during the course of the study. * Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

Primary outcome measure(s)

Trial sites (222)

FacilityCityRegionStatus
Research Site Birmingham Alabama
Research Site Bakersfield California
Research Site Fullerton California
Research Site Los Angeles California
Research Site Salinas California
Research Site Santa Barbara California
Research Site Truckee California
Research Site New Haven Connecticut
Research Site Washington D.C. District of Columbia
Research Site Orlando Florida
Research Site Chicago Illinois
Research Site Fort Wayne Indiana
Research Site Kansas City Kansas
Research Site Louisville Kentucky
Research Site New Orleans Louisiana
Research Site Grand Rapids Michigan
Research Site Bozeman Montana
Research Site New Hyde Park New York
Research Site New York New York
Research Site New York New York
Research Site Rochester New York
Research Site Germantown Tennessee
Research Site Fort Worth Texas
Research Site Ciudad de Buenos Aires Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site Rosario Argentina
Research Site Box Hill Australia
Research Site Elizabeth Vale Australia
Research Site Kogarah Australia
Research Site Macquarie University Australia
Research Site Murdoch Australia
Research Site Orange Australia
Research Site South Brisbane Australia
Research Site St Albans Australia
Research Site Curitiba Brazil
Research Site Fortaleza Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil

+ 182 more sites — see the full list on the official registry below.

On this site

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More AstraZeneca trials in the USA

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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 NCT03682068 on ClinicalTrials.gov ↗ ← All trials in the USA