Actively Recruiting
Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-06-29
63
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of a combination treatment involving atezolizumab, platinum, and etoposide chemotherapy for adults with locally advanced small cell neuroendocrine carcinoma of the bladder, with or without urothelial cancer components. This Phase II trial aims to evaluate the rate of complete tumor response after surgical removal of the bladder (cystectomy) following this treatment. The study focuses on patients who are fit for platinum-based chemotherapy and surgery, including those with certain resectable lymph node involvement. Participants will receive four cycles of chemotherapy every 21 days, consisting of atezolizumab 1200 mg by intravenous infusion on day 1, etoposide 100 mg/m2 on days 1 to 3, and either carboplatin or cisplatin on day 1. After completing chemotherapy, patients will undergo cystectomy within 42 days. Following surgery, maintenance atezolizumab infusions are given every 21 days for up to one year or until side effects or loss of benefit occur, as decided by the study doctors. Throughout the study, participants will undergo regular assessments including laboratory tests, imaging, and biopsies to monitor their response and safety. Researchers will measure the primary outcome of pathologic complete response at cystectomy up to 18 months. Secondary outcomes include disease-free survival, overall survival rates, safety and tolerability, incidence of brain metastases, and feasibility of the treatment combination. The study follow-up may last up to five years to capture long-term results and monitor participants' health.
CONDITIONS
Brief Title
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive bladder carcinoma with small cell or high-grade neuroendocrine features, localized stage cT1-T4aN1 or higher
- Submission of tumor tissue sample prior to enrollment or biopsy at screening if archival tissue is unavailable
- Medically fit for chemotherapy, immunotherapy, and cystectomy
- Age 18 years or older at time of consent
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function based on recent lab results
- Negative HIV and hepatitis B tests or stable HIV on therapy with specific lab criteria
- Creatinine clearance above 30, with >50 for patients receiving cisplatin
- Agreement to use contraception or abstain from sexual activity during and after treatment for specified periods if of childbearing potential
- Written informed consent according to local guidelines
- Use of certain corticosteroids or mineralocorticoids allowed under specified conditions
You will not qualify if you...
- Prior systemic treatment for small cell bladder cancer
- Concurrent invasive urothelial carcinoma in upper urinary tract, unless previously treated and disease-free
- Active second malignancy except certain low-risk cancers
- Prior systemic chemotherapy for urothelial bladder cancer (prior intravesical therapy allowed)
- Metastatic disease including brain metastases
- Uncontrolled tumor-related pain or symptomatic hypercalcemia
- Active or history of certain autoimmune diseases or immune deficiencies with exceptions
- History of lung diseases such as idiopathic pulmonary fibrosis or active pneumonitis
- Active tuberculosis
- Significant recent cardiovascular events or unstable heart conditions
- Recent major surgery or unresolved side effects from procedures
- History of other cancers within 5 years except low-risk types
- Severe infection or recent use of therapeutic antibiotics
- Prior organ transplantation
- Conditions or treatments contraindicating investigational drug use
- Recent live vaccine use or antiviral treatment for hepatitis B
- Prior immune checkpoint therapy or immunostimulatory agents
- Recent systemic immunosuppressive medication use
- Severe allergic reactions to similar antibodies
- Known allergies to study drugs
- Pregnancy, breastfeeding, or planning pregnancy during treatment
- Recent radiotherapy to bladder or unresolved radiotherapy toxicities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks (4 cycles of 21 days each)
Participants receive Atezolizumab combined with platinum-based chemotherapy and Etoposide every 3 weeks for 4 cycles.
4 visits every 3 weeks
Duration - Up to 6 weeks
Participants undergo cystectomy within 42 days after completing chemotherapy.
1 visit for surgery and follow-up visits as needed
Duration - Up to 1 year (up to 16 cycles)
Participants receive maintenance Atezolizumab every 3 weeks after surgery until unacceptable toxicity, loss of clinical benefit, or up to 1 year.
Visits every 3 weeks for up to 16 cycles
Trial Site Locations
Total: 2 locations
1
Johns Hopkins University: Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
D
Deborah Schwartz, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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