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OncoMatch/Clinical Trials/NCT05312671

Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer

Is NCT05312671 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Carboplatin for small cell neuroendocrine carcinoma of bladder.

Phase 2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT05312671Data as of May 2026

Treatment: Atezolizumab · Carboplatin · Cisplatin · EtoposideThis 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.

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Extracted eligibility criteria

Cancer type

Neuroendocrine Tumor

Urothelial Carcinoma

Disease stage

Required: Stage T4AN1 (AJCC TNM)

Grade: high grade

localized  cT1-T4aN1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic chemotherapy

Exception: Prior BCG and intravesical chemotherapy are allowed

No prior systemic treatment for small-cell bladder cancer (SCBC); Patients who have received prior systemic chemotherapy for urothelial bladder cancer. Prior BCG and intravesical chemotherapy are allowed

Cannot have received: immune checkpoint blockade therapy

Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

Cannot have received: systemic immunostimulatory agents (interferon, interleukin 2)

Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment

Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF-α agents)

Exception: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.

Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.

Cannot have received: radiation therapy

Patients who have had radiotherapy to the bladder, or radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities

Cannot have received: investigational therapy

Treatment with investigational therapy within 28 days prior to initiation of study treatment

Lab requirements

Blood counts

ANC ≥ 1500 cells/μL without G-CSF support; Lymphocyte count ≥ 500/μL; Platelet count ≥ 100,000/μL without transfusion; Hemoglobin ≥ 9.0 g/dL (transfusion allowed to meet criterion); INR or aPTT ≤ 1.5 × ULN (if not on anticoagulation)

Kidney function

Creatinine clearance >30. Patients receiving cisplatin must have creatinine clearance >50

Liver function

AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN; Serum bilirubin ≤ 1.5 × ULN (≤3 × ULN if Gilbert disease); Serum albumin ≥ 25 g/L (2.5 g/dL)

Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization: ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support; Lymphocyte count ≥ 500/μL; Platelet count ≥ 100,000/μL without transfusion; Hemoglobin ≥ 9.0 g/dL -patients may be transfused to meet this criterion. INR or aPTT ≤ 1.5 × upper limit of normal (ULN) This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN; Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled. Serum albumin ≥ 25 g/L (2.5 g/dL); Creatinine clearance >30. Patients receiving cisplatin must have creatinine clearance >50

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Johns Hopkins University: Sibley Memorial Hospital · Washington D.C., District of Columbia
  • Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland

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