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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Atezolizumab
DrugAtezolizumab 20 mL (1200 mg) on Day 1, once every 3 weeks for up to 20 cycles (each cycle = 21 days)
Carboplatin
DrugCarboplatin AUC 5 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).
Cisplatin
DrugCisplatin 70 mg/m2 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).
Etoposide
DrugEtoposide 100 mg/m2 IV on Days 1 - 3 every cycle for the first 4 cycles (each cycle = 21 days)
Cystectomy
Procedure/SurgeryCystectomy should be performed within 42 days after completion of last administered study therapy of induction phase (first 4 cycles of chemotherapy).
Treatment groups
63 Participants
are divided into 1 treatment groupGroup A: Atezolizumab with Platinum and Etoposide, followed by cystectomy.Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Pathologic complete response (ypCR) at cystectomy
The number of participants with pathological complete responses (ypCR) at cystectomy. Pathologic complete response is defined as post-treatment cystectomy tumor stages N0 and M0, with T-stage T0.
Time frame
up to 18 monthsSecondary outcomes
1
Number of participants with non-muscle invasive disease
Non-muscle invasive disease is defined as \<ypT1N0 at cystectomy.
Time frame
up to 18 months2
Safety and tolerability of combination chemotherapy and cystectomy as assessed by number of participants experiencing adverse events
Number of participants experiencing dose limiting toxicities and treatment-related adverse events, as defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Time frame
4.5 years3
Incidence of brain metastases in follow-up
Number of participants who develop brain metastases during follow-up
Time frame
up to 5 years4
1-year overall survival rate (1-yr OS)
Number of participants alive 1 year after last dose
Time frame
up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov