Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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.
Eligibility criteria
Qualifiers
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
Medically fit to undergo chemotherapy, immunotherapy and cystectomy
18 years old at time of consent
ECOG performance status of 0 or 1
Disqualifiers
No prior systemic treatment for small-cell bladder cancer (SCBC)
Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible). Individual cases will be discussed at investigator discretion.
Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.
Patients who have received prior systemic chemotherapy for urothelial bladder cancer.
Trial design
Treatments tested in this trial
- Atezolizumab
- Carboplatin
- Cisplatin
- Etoposide
- Cystectomy
Treatment groups
63 Participants
are divided into 1 treatment groupSponsors and collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov