Unresectable Locally Advanced Urothelial Cancer, Metastatic Urothelial Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Durvalumab, Tremelimumab, Cisplatin + Gemcitabine, Carboplatin + Gemcitabine
INN of investigational material :
Therapeutic category code : 42- Antineopl
Sponsors
Astrazeneca K.K
Eligibility
Sex/Gender
All
Inclusion criteria
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 or more in the opinion of the investigator - Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS is defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. In order to minimize confounding of OS, patients randomized to SoC (cisplatin + gemcitabine or carboplatin + gemcitabine) will not be allowed to crossover to durvalumab + SoC or durvalumab + tremelimumab + SoC combination therapy. The primary analysis of OS will be performed in the PD-L1-high population. | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Germany, Hungary, India, Israel, Italy, Philippines, Poland, Russian Federation, South Korea, Spain, Taiwan, Thailand, Turkey, United States of America, Vietnam
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed