Actively Recruiting
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-06-29
63
Participants Needed
2
Research Sites
379 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
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.
CONDITIONS
Official 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
- Must provide tumor tissue sample for testing before enrollment
- Medically fit for chemotherapy, immunotherapy, and bladder removal surgery
- At least 18 years old at consent
- ECOG performance status 0 or 1
- Adequate blood counts and organ function within 14 days before randomization
- Negative HIV test or stable on anti-retroviral therapy with adequate CD4 count and undetectable viral load
- Negative hepatitis B surface antigen and core antibody tests or confirmed negative HBV DNA if applicable
- Creatinine clearance over 30 mL/min (over 50 mL/min if receiving cisplatin)
- Women of childbearing potential must agree to abstain or use effective contraception during treatment and specified periods after
- Men must agree to abstain or use effective contraception during treatment and specified periods after
- Written informed consent given
- Patients on certain corticosteroids or mineralocorticoids for specific conditions are eligible
You will not qualify if you...
- Prior systemic treatment for small cell bladder cancer
- Concurrent invasive upper urinary tract urothelial carcinoma
- Active second malignancy other than non-melanoma skin cancer or controlled prostate cancer
- Prior systemic chemotherapy for urothelial bladder cancer (prior BCG or intravesical therapy allowed)
- Any metastatic disease including brain or leptomeningeal metastases
- Uncontrolled tumor-related pain not on stable medication
- Uncontrolled or symptomatic hypercalcemia
- Active or history of several autoimmune or immune deficiency diseases with specific exceptions
- History or active pneumonitis or pulmonary fibrosis
- Active tuberculosis
- Significant recent cardiovascular disease
- Recent major surgery or unresolved effects of recent procedures
- History of other malignancies within 5 years except certain low-risk cancers
- Recent severe infection or recent therapeutic antibiotics use
- Prior stem cell or organ transplant
- Other diseases or conditions that pose high risk or interfere with study
- Recent live attenuated vaccine use or anticipated need
- Current HBV antiviral therapy
- Recent investigational therapy use
- Prior immune checkpoint or CD137 agonist therapy
- Recent systemic immunostimulatory or immunosuppressive treatments
- History of severe allergic reactions to related antibodies
- Known hypersensitivity to study drugs or components
- Pregnancy, breastfeeding, or intention to become pregnant during study or within specified periods after
- Recent radiotherapy to bladder or unresolved radiotherapy toxicities
AI-Screening
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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
CONTACT
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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