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

• ClinicalTrials.gov Identifier: NCT02589717
• Expanded Access Status: Approved for marketing
• First Posted: October 28, 2015
• Last Update Posted: November 2, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Urothelial Carcinoma	Drug: Atezolizumab [TECENTRIQ]

Study Design

• Study Type: Expanded Access

See clinical trials of the intervention/treatment in this expanded access record.

• Official Title: An Open-Label, Multicenter, Expanded Access Program for Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy.
• Study Start Date: November 2015
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Interventions

Intervention Details:

• Drug: Atezolizumab [TECENTRIQ]
  Atezolizumab 1200 mg will be administered by IV infusion q3w. Initial IV infusion will be given over 60 minutes and subsequent infusions will be given over 30 minutes.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Scottsdale, Arizona, United States, 85258

Tucson, Arizona, United States, 85710

United States, California

Duarte, California, United States, 91010

Oakland, California, United States, 94611

Stanford, California, United States, 94305

United States, Colorado

Denver, Colorado, United States, 80218

United States, Connecticut

New Haven, Connecticut, United States, 06520

West Hartford, Connecticut, United States, 06119

United States, Florida

Miami Beach, Florida, United States, 33140

Tampa, Florida, United States, 33612

United States, Illinois

Harvey, Illinois, United States, 60426

Springfield, Illinois, United States, 62794-9677

United States, Indiana

Goshen, Indiana, United States, 46526

Indianapolis, Indiana, United States, 46237

United States, Iowa

Sioux City, Iowa, United States, 51101

United States, Kentucky

Louisville, Kentucky, United States, 40202

United States, Louisiana

New Orleans, Louisiana, United States, 70112

United States, Massachusetts

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02115

Boston, Massachusetts, United States, 02215

United States, Michigan

Ann Arbor, Michigan, United States, 48106

Detroit, Michigan, United States, 48202

United States, Minnesota

St. Cloud, Minnesota, United States, 56303

United States, Mississippi

Jackson, Mississippi, United States, 39202

United States, Missouri

Saint Louis, Missouri, United States, 63110

United States, New Mexico

Albuquerque, New Mexico, United States, 87131-0001

United States, New York

Abany, New York, United States, 12208

New York, New York, United States, 10016

Rochester, New York, United States, 14642

United States, Ohio

Columbus, Ohio, United States, 43210

United States, Oregon

Eugene, Oregon, United States, 97401-8122

United States, Pennsylvania

Easton, Pennsylvania, United States, 18045

Philadelphia, Pennsylvania, United States, 19107

Pittsburgh, Pennsylvania, United States, 15212

United States, South Carolina

Charleston, South Carolina, United States, 29425

United States, Texas

Houston, Texas, United States, 77030

San Antonio, Texas, United States, 78229

United States, Virginia

Charlottesville, Virginia, United States, 22908

Norfolk, Virginia, United States, 23502

United States, Washington

Spokane, Washington, United States, 99208

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT02589717
• Other Study ID Numbers: ML29725
• First Posted: October 28, 2015
• Last Update Posted: November 2, 2016
• Last Verified: November 2016

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Transitional Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Atezolizumab; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Antineoplastic Agents