An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

An Open-Label, Multicenter, Expanded Access Program for Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy.

This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to provide atezolizumab access to participants with locally advanced or metastatic urothelial carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy regimen.

Study Overview

• Status: Approved for marketing
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Drug: Atezolizumab [TECENTRIQ]

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
    • Tucson, Arizona, United States, 85710
  • California
    • Duarte, California, United States, 91010
    • Oakland, California, United States, 94611
    • Stanford, California, United States, 94305
  • Colorado
    • Denver, Colorado, United States, 80218
  • Connecticut
    • New Haven, Connecticut, United States, 06520
    • West Hartford, Connecticut, United States, 06119
  • Florida
    • Miami Beach, Florida, United States, 33140
    • Tampa, Florida, United States, 33612
  • Illinois
    • Harvey, Illinois, United States, 60426
    • Springfield, Illinois, United States, 62794-9677
  • Indiana
    • Goshen, Indiana, United States, 46526
    • Indianapolis, Indiana, United States, 46237
  • Iowa
    • Sioux City, Iowa, United States, 51101
  • Kentucky
    • Louisville, Kentucky, United States, 40202
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
    • Boston, Massachusetts, United States, 02114
    • Boston, Massachusetts, United States, 02115
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
    • Detroit, Michigan, United States, 48202
  • Minnesota
    • St. Cloud, Minnesota, United States, 56303
  • Mississippi
    • Jackson, Mississippi, United States, 39202
  • Missouri
    • Saint Louis, Missouri, United States, 63110
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
  • New York
    • Abany, New York, United States, 12208
    • New York, New York, United States, 10016
    • Rochester, New York, United States, 14642
  • Ohio
    • Columbus, Ohio, United States, 43210
  • Oregon
    • Eugene, Oregon, United States, 97401-8122
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
    • Philadelphia, Pennsylvania, United States, 19107
    • Pittsburgh, Pennsylvania, United States, 15212
  • South Carolina
    • Charleston, South Carolina, United States, 29425
  • Texas
    • Houston, Texas, United States, 77030
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Charlottesville, Virginia, United States, 22908
    • Norfolk, Virginia, United States, 23502
  • Washington
    • Spokane, Washington, United States, 99208

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to comply with the study protocol, in the investigator's judgment
• Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra)
• Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], carboplatin and gemcitabine [CarboGem], etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Life expectancy >/= 12 weeks
• Adequate hematologic and end-organ function, defined by laboratory results obtained within 14 days prior to the first study treatment
• For women who are not postmenopausal (>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 90 days after the last dose of study drug

Exclusion Criteria:

• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
• Treatment with chemotherapy 14 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
• Treatment with radiotherapy 7 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
• Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
• Pregnant or lactating, or intending to become pregnant during the study
• Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
• Severe infections within 4 weeks prior to enrollment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
• Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of disease or a condition that contraindicates the use of the investigational drug or renders the participant at high risk for treatment complications
• Participants with active hepatitis B
• Active tuberculosis
• Administration of a live, attenuated vaccine within 4 weeks prior to enrollment or anticipation that such a live, attenuated vaccine will be required during the study
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
• Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to enrollment or anticipated requirement for systemic immunosuppressive medications during the trial

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimated): October 28, 2015

Study Record Updates

• Last Update Posted (Estimated): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: ML29725