Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide.
The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible. Participants will receive: Atezolizumab 1,200 mg IV Day 1 Etoposide 100 mg/m2 IV on Days 1-3 Carboplatin AUC 5 IV on Day 1 or Cisplatin 70 mg/m2 IV on Day 1 (Patie…
Inclusion Criteria: * Histologically confirmed invasive carcinoma of the bladder with pure, or any component of, small cell or high grade neuroendocrine features with or without urothelial cancer - localized ≥ cT1-T4aN1 A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If less than 15 slides are available, the patient may still be eligible for the study, after Principal Investigator confirmatio…
Atezolizumab 20 mL (1200 mg) on Day 1, once every 3 weeks for up to 20 cycles (each cycle = 21 days)
Carboplatin AUC 5 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).
Cisplatin 70 mg/m2 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).
Etoposide 100 mg/m2 IV on Days 1 - 3 every cycle for the first 4 cycles (each cycle = 21 days)
Cystectomy should be performed within 42 days after completion of last administered study therapy of induction phase (first 4 cycles of chemotherapy).
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