Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05312671
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bladder Cancer
  • Small Cell Neuroendocrine Carcinoma of Bladder
  • Urothelial Carcinoma Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 20 mL (1200 mg) on Day 1, once every 3 weeks for up to 20 cycles (each cycle = 21 days)
  • Carboplatin — DRUG
    Carboplatin AUC 5 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).
  • Cisplatin — DRUG
    Cisplatin 70 mg/m2 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).
  • Etoposide — DRUG
    Etoposide 100 mg/m2 IV on Days 1 - 3 every cycle for the first 4 cycles (each cycle = 21 days)
  • Cystectomy — PROCEDURE
    Cystectomy should be performed within 42 days after completion of last administered study therapy of induction phase (first 4 cycles of chemotherapy).

Study Details

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.

Key Dates

Start date
Jun 27, 2022
Status verified
Jun 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab with Platinum and Etoposide, followed by cystectomy.
    The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible. Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg Day 1 of every 21 day cycle with chemotherapy x 4 cycles. Following cystectomy, Atezolizumab maintenance Q 21 days will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease), or up to 1 year (e.g., 16 cycles).

Primary Outcome Measure

Pathologic complete response (ypCR) at cystectomy [ Time Frame: up to 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins University: Sibley Memorial HospitalWashington D.C.District of Columbia20016
Carol Goldener, RN
[email protected]
202-660-5629
Jean Hoffman-Censits, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Deborah Schwartz, RN
[email protected]
410-502-4523
Jean Hoffman-Censtis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Johns Hopkins University: Sibley Memorial Hospital· Washington D.C., DCJohns Hopkins University: Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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