Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of MPDL3280A in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 7, 2014
Last updated: March 2, 2015
Last verified: March 2015

This phase II, single-arm study was designed to evaluate the effect of MPDL3280A treatment in patients with locally advanced or metastatic urothelial bladder cancer. Patients will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of patients who are treatment-naïve and ineligible for platinum-containing therapy. Cohort 2 will contain patients who have progressed during or following a prior platinum-based chemotherapy regimen. Patients in both cohorts will be given a 1200 mg intravenous (IV) dose of MPDL3280A on Day 1 of 21-day cycles. Treatment may continue for up to 16 cycles or 12 months, whichever is first, in the absence of toxicity or disease progression. Patients will be followed for up for 2 years. Patients who complete the initial treatment stage of up to 16 cycles may be eligible for MPDL3280A re-treatment upon subsequent disease progression during the follow-up period and without intervening systemic anti-cancer therapy.

Condition Intervention Phase
Carcinoma, Transitional Cell , Bladder Cancer, Bladder Tumors, Urinary Bladder Neoplasms
Drug: MPDL3280A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response (DOR) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies to MPDL3280A [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) of MPDL3280A [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Treatment-naive and cisplatin-ineligible patients
Drug: MPDL3280A
1200 mg dose given by intravenous infusion (IV) on Day 1 of 21-day cycles for up to 16 cycles or 12 months (whichever comes first)
Experimental: Cohort 2
Patients with disease progression following or during platinum-containing treatment
Drug: MPDL3280A
1200 mg dose given by intravenous infusion (IV) on Day 1 of 21-day cycles for up to 16 cycles or 12 months (whichever comes first)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >/= 18 years
  • Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
  • Representative tumor specimens as specified by the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy >/= 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Cohort 1-Specific Inclusion Criteria

  • Ineligible for cisplatin-based chemotherapy due to one of the following:
  • Impaired renal function
  • A hearing loss of 25 dB at two contiguous frequencies
  • Grade 2 or greater peripheral neuropathy
  • ECOG performance score of 2

Cohort 2-Specific Inclusion Criteria

  • 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], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence

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 CT or 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 treated with expected curative outcome or incidental prostate cancer
  • Pregnant and lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Serum albumin < 2.5 g/dL
  • Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Significant cardiovascular disease
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
  • Prior allogeneic stem cell or solid organ transplant
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02108652

Contact: Reference Study ID Number: GO29293 888-662-6728 (U.S. Only)

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Active, not recruiting
Scottsdale, Arizona, United States, 85258
Active, not recruiting
Tucson, Arizona, United States, 85710
United States, California
Los Angeles, California, United States, 90025
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90024
Active, not recruiting
San Francisco, California, United States, 94143-0106
Active, not recruiting
San Marcos, California, United States, 92069
Active, not recruiting
Stanford, California, United States, 94305-5820
Vallejo, California, United States, 94589
United States, Colorado
Active, not recruiting
Aurora, Colorado, United States, 80045
Active, not recruiting
Aurora, Colorado, United States, 80012
United States, Connecticut
Active, not recruiting
Farmington, Connecticut, United States, 06030
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Active, not recruiting
Jacksonville, Florida, United States, 32224
United States, Georgia
Atlanta, Georgia, United States, 30318
United States, Illinois
Chicago, Illinois, United States, 60637
Harvey, Illinois, United States, 60426
United States, Indiana
Active, not recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
Active, not recruiting
Louisville, Kentucky, United States, 40402
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Boston, Massachusetts, United States, 02115
Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
United States, Minnesota
Active, not recruiting
Minneapolis, Minnesota, United States, 55404
Rochester, Minnesota, United States, 55905
United States, Nebraska
Active, not recruiting
Omaha, Nebraska, United States, 68130
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
Active, not recruiting
Abany, New York, United States, 12208
New York, New York, United States, 10065
New York, New York, United States, 10016
Active, not recruiting
New York, New York, United States, 10029
United States, Ohio
Active, not recruiting
Cincinnati, Ohio, United States, 45242
Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland, Ohio, United States, 44195
United States, Oregon
Active, not recruiting
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Active, not recruiting
Fort Worth, Texas, United States, 76104
Active, not recruiting
Houston, Texas, United States, 77024
Active, not recruiting
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Virginia
Fairfax, Virginia, United States, 22031
Norfolk, Virginia, United States, 23502
United States, Washington
Active, not recruiting
Seattle, Washington, United States, 98109
Canada, British Columbia
Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Active, not recruiting
Oshawa, Ontario, Canada, L1G 2B9
Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Not yet recruiting
Paris, France, 75475
Active, not recruiting
Suresnes, France, 92151
Active, not recruiting
Villejuif, France, 94800
Berlin, Germany, 12200
Active, not recruiting
Düsseldorf, Germany, 40225
Freiburg, Germany, 79106
Active, not recruiting
Hamburg, Germany, 20246
Active, not recruiting
München, Germany, 81675
Active, not recruiting
Milano, Lombardia, Italy, 20133
Active, not recruiting
Arezzo, Toscana, Italy, 52100
Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Active, not recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Active, not recruiting
Pamplona, Navarra, Spain, 31008
Active, not recruiting
Barcelona, Spain, 08035
Madrid, Spain, 28041
Madrid, Spain, 28034
Active, not recruiting
Madrid, Spain, 28007
Sevilla, Spain, 41013
United Kingdom
Birmingham, United Kingdom, B15 2TH
Active, not recruiting
London, United Kingdom, W1G 6AD
London, United Kingdom, E1 2AD
Sutton, United Kingdom, SM2 5PT
Active, not recruiting
Wirral, United Kingdom, L63 4JY
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT02108652     History of Changes
Other Study ID Numbers: GO29293
Study First Received: April 7, 2014
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
bladder cancer

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on March 03, 2015