Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
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)
Overall Survival (OS) — approximately 5 years OS is defined as the time from the date of randomization until death due to any cause
Trial sites (222)
Facility
City
Region
Status
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.
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.
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