Neoadjuvant Atezolizumab in Localized Bladder Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Lawrence Fong
Study ID
NCT02451423
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Transitional Cell

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies the best dose of atezolizumab in treating patients with bladder cancer that has not spread to other places in the body. Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Mar 29, 2016
Status verified
May 2024
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1: Atezolizumab (Single dose)
    Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
  • Experimental: Cohort A2: Atezolizumab Monotherapy (2 doses)
    Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
  • Experimental: Cohort A3: Atezolizumab Monotherapy (3 doses)
    Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)

Primary Outcome Measure

Mean log2 (Fold Change of CD3+ T-Cell Count/µm2) Over Time [ Time Frame: Up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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University of California, San Francisco· San Francisco, CA

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