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



Status:Recruiting
Healthy:No
Age Range:18 - 99
Updated:3/27/2019
Start Date:September 27, 2018
End Date:April 27, 2022
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

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).


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
We found this trial at
26
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Fountain Valley, California 92708
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Santa Barbara, California 93105
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