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Urothelial CarcinomaNCT02589717

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

A study testing Atezolizumab [TECENTRIQ] in people with Urothelial Carcinoma, run by Genentech, Inc. at 40 sites in United States.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Atezolizumab [TECENTRIQ]
Type of treatment
Injection or infusion
How many people
Not given
Where
40 sitesUnited States
Study dates
Nov 2015to Aug 2016
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Study site

    Abany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87131-0001

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Denver, Colorado, 80218

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Duarte, California, 91010

  • Study site

    Easton, Pennsylvania, 18045

  • Study site

    Eugene, Oregon, 97401-8122

  • Study site

    Goshen, Indiana, 46526

  • Study site

    Harvey, Illinois, 60426

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10016

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oakland, California, 94611

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Rochester, New York, 14642

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Sioux City, Iowa, 51101

  • Study site

    Spokane, Washington, 99208

  • Study site

    Springfield, Illinois, 62794-9677

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stanford, California, 94305

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tucson, Arizona, 85710

  • Study site

    West Hartford, Connecticut, 06119

Other trials in United States

About this study

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.

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.

Being tested
Atezolizumab [TECENTRIQ]
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab [TECENTRIQ]Drug

    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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT02589717
Sponsor's protocol ID
ML29725
Status last verified
Nov 2016
First submitted
16 Oct 2015
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Atezolizumab [TECENTRIQ] in people with Urothelial Carcinoma, run by Genentech, Inc. at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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Clinical Trial NCT02589717 | AzTrials