A Study of MPDL3280A Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Chemotherapy Type: Drug
Name: MPDL3280A Type: Drug
Overall Status
Recruiting
Summary
This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of MPDL3280A compared with chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 767 patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age >/= 18 years

- Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)

- Representative tumor specimens as specified by the protocol

- Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Life expectancy >/= 12 weeks

- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

- Adequate hematologic and end organ function

- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception as defined by the protocol and to continue its use for 6 months after the last dose of MPDL3280A

Exclusion Criteria:

- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment

- Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments

- Leptomeningeal disease

- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

- Pregnant and lactating women

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to randomization

- Major surgical procedure other than for diagnosis within 4 weeks prior to randomization

- 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 MPDL3280A formulation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplant

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan

- Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks prior to randomization

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Locations
Washington, District of Columbia, United States
Status: Recruiting
Atlanta, Georgia, United States
Status: Recruiting
Las Vegas, Nevada, United States
Status: Recruiting
Durham, North Carolina, United States
Status: Recruiting
Greenville, South Carolina, United States
Status: Active, not recruiting
Nashville, Tennessee, United States
Status: Recruiting
Herston, Queensland, Australia
Status: Recruiting
Adelaide, South Australia, Australia
Status: Recruiting
East Bentleigh, Victoria, Australia
Status: Recruiting
Melbourne, Victoria, Australia
Status: Recruiting
Wien, Austria
Status: Recruiting
Wien, Austria
Status: Recruiting
Antwerpen, Belgium
Status: Recruiting
Bruxelles, Belgium
Status: Recruiting
Gent, Belgium
Status: Recruiting
Kortrijk, Belgium
Status: Active, not recruiting
Leuven, Belgium
Status: Recruiting
Calgary, Alberta, Canada
Status: Recruiting
Kelowna, British Columbia, Canada
Status: Active, not recruiting
Vancouver, British Columbia, Canada
Status: Recruiting
Victoria, British Columbia, Canada
Status: Recruiting
Barrie, Ontario, Canada
Status: Recruiting
London, Ontario, Canada
Status: Recruiting
Oshawa, Ontario, Canada
Status: Recruiting
Ottawa, Ontario, Canada
Status: Recruiting
Sault Ste Marie, Ontario, Canada
Status: Recruiting
Toronto, Ontario, Canada
Status: Recruiting
Montreal, Quebec, Canada
Status: Recruiting
Brno, Czech Republic
Status: Active, not recruiting
Olomouc, Czech Republic
Status: Recruiting
Pardubice, Czech Republic
Status: Recruiting
Praha 2, Czech Republic
Status: Recruiting
Praha, Czech Republic
Status: Recruiting
Aarhus C, Denmark
Status: Not yet recruiting
Herlev, Denmark
Status: Active, not recruiting
København, Denmark
Status: Not yet recruiting
Helsinki, Finland
Status: Recruiting
Turku, Finland
Status: Recruiting
Angers, France
Status: Recruiting
Avignon, France
Status: Recruiting
Besancon, France
Status: Recruiting
Bordeaux, France
Status: Recruiting
Bordeaux, France
Status: Not yet recruiting
Caen, France
Status: Not yet recruiting
Creteil, France
Status: Active, not recruiting
Limoges, France
Status: Active, not recruiting
Lyon, France
Status: Recruiting
Marseille, France
Status: Recruiting
Montpellier, France
Status: Recruiting
Nancy, France
Status: Recruiting
Nice, France
Status: Recruiting
Nimes, France
Status: Active, not recruiting
Paris, France
Status: Recruiting
Paris, France
Status: Recruiting
Paris, France
Status: Recruiting
Paris, France
Status: Not yet recruiting
Pierre Benite, France
Status: Active, not recruiting
Rouen, France
Status: Recruiting
Saint Herblain, France
Status: Recruiting
Strasbourg, France
Status: Active, not recruiting
Suresnes, France
Status: Recruiting
Toulouse, France
Status: Recruiting
Villejuif, France
Status: Recruiting
Aachen, Germany
Status: Recruiting
Berlin, Germany
Status: Recruiting
Dresden, Germany
Status: Recruiting
Düsseldorf, Germany
Status: Recruiting
Erlangen, Germany
Status: Recruiting
Freiburg, Germany
Status: Recruiting
Göttingen, Germany
Status: Active, not recruiting
Hamburg, Germany
Status: Recruiting
Heidelberg, Germany
Status: Active, not recruiting
Homburg/Saar, Germany
Status: Not yet recruiting
Magdeburg, Germany
Status: Recruiting
Mannheim, Germany
Status: Recruiting
München, Germany
Status: Recruiting
Tübingen, Germany
Status: Not yet recruiting
Athens, Greece
Status: Recruiting
Heraklion, Crete, Greece
Status: Not yet recruiting
Patras, Greece
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Kecskemét, Hungary
Status: Recruiting
Szolnok, Hungary
Status: Recruiting
Napoli, Campania, Italy
Status: Recruiting
Meldola, Emilia-Romagna, Italy
Status: Active, not recruiting
Modena, Emilia-Romagna, Italy
Status: Recruiting
Udine, Friuli-Venezia Giulia, Italy
Status: Recruiting
Roma, Lazio, Italy
Status: Recruiting
Bergamo, Lombardia, Italy
Status: Active, not recruiting
Cremona, Lombardia, Italy
Status: Recruiting
Milano, Lombardia, Italy
Status: Recruiting
Candiolo, Piemonte, Italy
Status: Recruiting
San Giovanni Rotondo, Puglia, Italy
Status: Active, not recruiting
Palermo, Sicilia, Italy
Status: Recruiting
Arezzo, Toscana, Italy
Status: Recruiting
Firenze, Toscana, Italy
Status: Active, not recruiting
Aichi, Japan
Status: Recruiting
Aomori, Japan
Status: Recruiting
Chiba, Japan
Status: Completed
Chiba, Japan
Status: Recruiting
Ehime, Japan
Status: Recruiting
Fukuoka, Japan
Status: Recruiting
Fukuoka, Japan
Status: Recruiting
Gunma, Japan
Status: Recruiting
Hiroshima, Japan
Status: Recruiting
Hokkaido, Japan
Status: Recruiting
Hokkaido, Japan
Status: Recruiting
Ibaraki, Japan
Status: Active, not recruiting
Iwate, Japan
Status: Active, not recruiting
Kanagawa, Japan
Status: Recruiting
Kumamoto, Japan
Status: Recruiting
Niigata, Japan
Status: Recruiting
Osaka, Japan
Status: Recruiting
Osaka, Japan
Status: Recruiting
Osaka, Japan
Status: Recruiting
Shizuoka, Japan
Status: Recruiting
Tokushima, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Recruiting
Tokyo, Japan
Status: Recruiting
Tokyo, Japan
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Recruiting
Amsterdam, Netherlands
Status: Recruiting
Hoofddorp, Netherlands
Status: Recruiting
Maastricht, Netherlands
Status: Not yet recruiting
Nieuwegein, Netherlands
Status: Recruiting
Zwolle, Netherlands
Status: Not yet recruiting
Kristiansand, Norway
Status: Recruiting
Tromsø, Norway
Status: Recruiting
Trondheim, Norway
Status: Recruiting
Bialystok, Poland
Status: Recruiting
Gdansk, Poland
Status: Recruiting
Lublin, Poland
Status: Active, not recruiting
Poznan, Poland
Status: Recruiting
Warszawa, Poland
Status: Active, not recruiting
Wroclaw, Poland
Status: Not yet recruiting
Lisboa, Portugal
Status: Active, not recruiting
Loures, Portugal
Status: Active, not recruiting
Porto, Portugal
Status: Recruiting
Baia Mare, Romania
Status: Recruiting
Bucharest, Romania
Status: Recruiting
Cluj-napoca, Romania
Status: Not yet recruiting
Craiova, Romania
Status: Active, not recruiting
Iasi, Romania
Status: Not yet recruiting
Targu Mures, Romania
Status: Not yet recruiting
Timisoara, Romania
Status: Recruiting
Barnaul, Russian Federation
Status: Not yet recruiting
Moscow, Russian Federation
Status: Not yet recruiting
Nizhni Novgorod, Russian Federation
Status: Not yet recruiting
Saint-Petersburg, Russian Federation
Status: Not yet recruiting
St Petersburg, Russian Federation
Status: Not yet recruiting
Stavropol, Russian Federation
Status: Not yet recruiting
Belgrade, Serbia
Status: Not yet recruiting
Sremska Kamenica, Serbia
Status: Not yet recruiting
Ljubljana, Slovenia
Status: Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Status: Active, not recruiting
Sabadell, Barcelona, Spain
Status: Active, not recruiting
Palma De Mallorca, Islas Baleares, Spain
Status: Recruiting
Santiago de Compostela, La Coruña, Spain
Status: Active, not recruiting
Pamplona, Navarra, Spain
Status: Recruiting
Barcelona, Spain
Status: Active, not recruiting
Barcelona, Spain
Status: Recruiting
Barcelona, Spain
Status: Active, not recruiting
Cordoba, Spain
Status: Active, not recruiting
Madrid, Spain
Status: Recruiting
Madrid, Spain
Status: Active, not recruiting
Madrid, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Navarra, Spain
Status: Active, not recruiting
Sevilla, Spain
Status: Recruiting
Göteborg, Sweden
Status: Active, not recruiting
Stockholm, Sweden
Status: Recruiting
Umea, Sweden
Status: Recruiting
Bern, Switzerland
Status: Recruiting
Chur, Switzerland
Status: Active, not recruiting
Geneve, Switzerland
Status: Recruiting
St. Gallen, Switzerland
Status: Recruiting
Zürich, Switzerland
Status: Recruiting
Taichung, Taiwan
Status: Recruiting
Taichung, Taiwan
Status: Active, not recruiting
Taipei, Taiwan
Status: Active, not recruiting
Taipei, Taiwan
Status: Recruiting
Bursa, Turkey
Status: Not yet recruiting
Edirne, Turkey
Status: Not yet recruiting
Istanbul, Turkey
Status: Not yet recruiting
Istanbul, Turkey
Status: Not yet recruiting
Istanbul, Turkey
Status: Not yet recruiting
Izmir, Turkey
Status: Not yet recruiting
Malatya, Turkey
Status: Not yet recruiting
Sıhhiye, ANKARA, Turkey
Status: Not yet recruiting
Birmingham, United Kingdom
Status: Not yet recruiting
Bristol, United Kingdom
Status: Not yet recruiting
Cambridge, United Kingdom
Status: Recruiting
Cheltenham, United Kingdom
Status: Recruiting
Coventry, United Kingdom
Status: Recruiting
Exeter, United Kingdom
Status: Recruiting
Lancaster, United Kingdom
Status: Recruiting
Leeds, United Kingdom
Status: Active, not recruiting
Leicester, United Kingdom
Status: Active, not recruiting
London, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
Newcastle Upon Tyne, United Kingdom
Status: Recruiting
Nottingham, United Kingdom
Status: Recruiting
Oxford, United Kingdom
Status: Recruiting
Scunthorpe, United Kingdom
Status: Recruiting
Southampton, United Kingdom
Status: Recruiting
Sutton, United Kingdom
Status: Recruiting
Truro, United Kingdom
Status: Recruiting
Wirral, United Kingdom
Status: Recruiting
Start Date
January 2015
Completion Date
January 2017
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page