Primary Outcomes:

Primary Outcome 1 - Measure: Overall Survival (OS)

Primary Outcome 1 - Time Frame: approximately 5 years

Condition:

• Unresectable Locally Advanced Urothelial Cancer
• Metastatic Urothelial Cancer

Eligibility

Criteria:
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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No