ClinicalTrials.gov

History of Changes for Study: NCT02302807
A Study of MPDL3280A Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Latest version (submitted July 5, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 26, 2014 None (earliest Version on record)
2 December 2, 2014 Arms and Interventions, Study Status and Contacts/Locations
3 December 8, 2014 Recruitment Status, Contacts/Locations, Study Status and Study Description
4 December 23, 2014 Contacts/Locations and Study Status
5 December 29, 2014 Contacts/Locations and Study Status
6 January 6, 2015 Study Status and Contacts/Locations
7 January 19, 2015 Contacts/Locations and Study Status
8 January 26, 2015 Study Status and Contacts/Locations
9 February 5, 2015 Contacts/Locations, Study Status and Study Description
10 February 12, 2015 Contacts/Locations and Study Status
11 February 23, 2015 Contacts/Locations and Study Status
12 March 2, 2015 Study Status
13 March 9, 2015 Contacts/Locations and Study Status
14 March 16, 2015 Contacts/Locations and Study Status
15 March 23, 2015 Contacts/Locations and Study Status
16 April 2, 2015 Contacts/Locations and Study Status
17 May 5, 2015 Study Status
18 May 11, 2015 Contacts/Locations and Study Status
19 May 29, 2015 Contacts/Locations and Study Status
20 June 1, 2015 Study Status and Contacts/Locations
21 July 1, 2015 Contacts/Locations and Study Status
22 July 31, 2015 Contacts/Locations and Study Status
23 August 17, 2015 Contacts/Locations and Study Status
24 September 1, 2015 Contacts/Locations and Study Status
25 September 9, 2015 Contacts/Locations and Study Status
26 October 1, 2015 Contacts/Locations and Study Status
27 November 2, 2015 Contacts/Locations and Study Status
28 November 12, 2015 Arms and Interventions, Contacts/Locations, Study Identification, Outcome Measures, Study Description and Study Status
29 December 1, 2015 Contacts/Locations, Arms and Interventions and Study Status
30 December 31, 2015 Contacts/Locations and Study Status
31 February 1, 2016 Contacts/Locations and Study Status
32 March 1, 2016 Recruitment Status, Contacts/Locations, Study Status and Study Design
33 April 2, 2016 Contacts/Locations, Study Status and Study Design
34 May 4, 2016 Study Status
35 June 1, 2016 Study Status and Contacts/Locations
36 July 1, 2016 Study Status and Study Design
37 August 1, 2016 Study Status and Contacts/Locations
38 August 16, 2016 Arms and Interventions, Outcome Measures, Study Status, Study Identification, Eligibility and Study Description
39 September 8, 2016 Arms and Interventions, Study Status, Eligibility, Outcome Measures, Study Description and Study Identification
40 October 3, 2016 Study Status
41 November 1, 2016 Study Status and Contacts/Locations
42 February 28, 2017 Contacts/Locations and Study Status
43 April 4, 2017 Study Status and Contacts/Locations
44 May 5, 2017 Contacts/Locations and Study Status
45 August 1, 2017 Study Status and Contacts/Locations
46 December 11, 2017 Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
47 March 13, 2018 Outcome Measures, Study Status, Contacts/Locations, Document Section and Results
48 May 7, 2018 Contacts/Locations and Study Status
49 July 30, 2018 Contacts/Locations and Study Status
50 September 13, 2018 Study Status, Outcome Measures and Contacts/Locations
51 October 15, 2018 Study Status
52 December 20, 2018 Recruitment Status and Study Status
53 July 5, 2019 Adverse Events, Outcome Measures, Participant Flow, Document Section, Contacts/Locations, Study Status and Eligibility
Comparison Format:

Scroll up to access the controls

Study NCT02302807
Submitted Date:  November 26, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: GO29294
Brief Title: A Study of MPDL3280A Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Official Title: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY
Secondary IDs: 2014-003231-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2014
Overall Status: Not yet recruiting
Study Start: December 2014
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: November 25, 2014
First Submitted that
Met QC Criteria:
November 26, 2014
First Posted: November 27, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 26, 2014
Last Update Posted: November 27, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, contr olled 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.
Detailed Description:
Open or close this module Conditions
Conditions: Bladder Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 767 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A: MPDL3280A Drug: MPDL2380A
MPDL2380A, 1200 mg by intravenous infusion on Day 1 of each 21-day cycle
Active Comparator: Arm B: Control Chemotherapy
Prior to randomization, the investigator will have the option of choosing one of three chemotherapy regimens (vinflunine, paclitaxel, or docetaxel) for each patient. The ratio of patients who are randomized to vinflunine versus patients who are randomized to a taxane (paclitaxel or docetaxel) will be approximately 1:1
Drug: vinflunine, paclitaxel, or docetaxel
per the investigator's choice and administered according to local label
Other Names:
  • Chemotherapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall survival
[ Time Frame: Between randomization and death due to any cause, up to approximately 23 months after first patient enrolled ]

Secondary Outcome Measures:
1. Objective response rate (ORR)
[ Time Frame: Up to approximately 23 months after first patient enrolled ]

2. Progression-free survival (PFS)
[ Time Frame: Up to approximately 23 months after first patient enrolled ]

3. Duration of response (DOR)
[ Time Frame: Up to approximately 23 months after first patient enrolled ]

4. Incidence of adverse events (AEs)
[ Time Frame: Up to approximately 23 months after first patient enrolled ]

5. Incidence of anti-therapeutic antibodies to MPDL3280A
[ Time Frame: Up to approximately 23 months after first patient enrolled ]

6. Maximum serum concentration (Cmax) of MPDL3280A
[ Time Frame: Up to approximately 23 months after first patient enrolled ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GO29294 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. Only)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, District of Columbia
Washington, District of Columbia, United States, 20057
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, South Carolina
Charleston, South Carolina, United States, 29414
United States, Tennessee
Nashville, Tennessee, United States, 37232
Australia, Queensland
Herston, Queensland, Australia, 4029
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
East Bentleigh, Victoria, Australia, VIC 3165
Melbourne, Victoria, Australia, 3084
Austria
Wien, Austria, 1090
Wien, Austria, 1100
Belgium
Antwerpen, Belgium, 2020
Bruxelles, Belgium, 1000
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver, British Columbia, Canada, V5Z 4E6
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
Barrie, Ontario, Canada, L4M 6M2
London, Ontario, Canada, N6A 4L6
Oshawa, Ontario, Canada, L1G 2B9
Ottawa, Ontario, Canada, K1H 8L6
Sault Ste Marie, Ontario, Canada, P6A 2C4
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H3G 1A4
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
Brno, Czech Republic, 656 53
Olomouc, Czech Republic, 77520
Pardubice, Czech Republic, 532 03
Praha, Czech Republic, 100 34
Praha, Czech Republic, 128 08
Denmark
Aarhus C, Denmark, 8000
Herlev, Denmark, 2730
København, Denmark, 2100
Finland
Helsinki, Finland, 00180
Turku, Finland, 20520
France
Angers, France, 49933
Avignon, France, 84918
Besancon, France, 25030
Bordeaux, France, 33075
Bordeaux, France, 33076
Caen, France, 14076
Creteil, France, 94010
Limoges, France, 87039
Lyon, France, 69373
Marseille, France, 13009
Montpellier, France, 34298
Nancy, France, 54100
Nimes, France, 30029
Paris, France, 75014
Paris, France, 75231
Paris, France, 75475
Paris, France, 75908
Pierre Benite, France, 69495
Rouen, France, 76031
Saint Herblain, France, 44805
Strasbourg, France, 67098
Suresnes, France, 92151
Toulouse, France, 31059
Villejuif, France, 94805
Germany
Aachen, Germany, 52074
Berlin, Germany, 12200
Dresden, Germany, 01307
Erlangen, Germany, 91054
Göttingen, Germany, 37075
Heidelberg, Germany, 69120
Homburg/Saar, Germany, 66424
Magdeburg, Germany, 39120
München, Germany, 81675
Greece
Athens, Greece, 11528
Heraklion, Greece, 711 10
Larissa, Greece, 41 110
Patras, Greece, 265 00
Hungary
Budapest, Hungary, 1082
Budapest, Hungary, 1122
Budapest, Hungary, 1145
Kecskemét, Hungary, 6000
Szolnok, Hungary, 5004
Italy, Campania
Napoli, Campania, Italy, 80131
Italy, Emilia-Romagna
Meldola, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41100
Italy, Friuli-Venezia Giulia
Udine, Friuli-Venezia Giulia, Italy, 33100
Italy, Lazio
Roma, Lazio, Italy, 00152
Italy, Lombardia
Bergamo, Lombardia, Italy, 24128
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20133
Italy, Piemonte
Candiolo, Piemonte, Italy, 10060
Italy, Puglia
San Giovanni Rotondo, Puglia, Italy, 71013
Italy, Sicilia
Palermo, Sicilia, Italy, 90146
Italy, Toscana
Arezzo, Toscana, Italy, 52100
Firenze, Toscana, Italy, 50139
Korea, Republic of
Seoul, Korea, Republic of, 110744
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Netherlands
Amsterdam, Netherlands, 1066 CX
Hoofddorp, Netherlands, 2134 TM
Nieuwegein, Netherlands, 3430 EM
Rotterdam, Netherlands, 3075 EA
Zwolle, Netherlands, 8011 JW
Norway
Kristiansand, Norway, 4604
Poland
Bialystok, Poland, 15-027
Gdansk, Poland, 80-952
Lublin, Poland, 20-090
Poznan, Poland, 60-569
Warszawa, Poland, 02-781
Wroclaw, Poland, 50-556
Portugal
Lisboa, Portugal, 1649-035
Loures, Portugal, 2674-514
Porto, Portugal, 4200-072
Romania
Baia Mare, Romania, 430031
Bucharest, Romania, 022338
Cluj-napoca, Romania, 400015
Craiova, Romania, 200385
Iasi, Romania, 700106
Targu Mures, Romania, 540142
Timisoara, Romania, 300239
Russian Federation
Barnaul, Russian Federation, 656049
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125284
Nizhni Novgorod, Russian Federation, 603001
Omsk, Russian Federation, 644013
Saint-Petersburg, Russian Federation, 190013
St Petersburg, Russian Federation
Serbia
Belgrade, Serbia, 11000
Sremska Kamenica, Serbia, 21204
Slovenia
Ljubljana, Slovenia, 1000
Sweden
Göteborg, Sweden, 413 45
Stockholm, Sweden, 17176
Umea, Sweden, 90185
Switzerland
Bern, Switzerland, 3010
Chur, Switzerland, 7000
Genève, Switzerland, 1211 14
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8091
Taiwan
Taichung, Taiwan, 407
Taichung, Taiwan
Taipei, Taiwan, 100
Taipei, Taiwan
Turkey
Bursa, Turkey, 16059
Edirne, Turkey, 22770
Istanbul, Turkey, 34286
Istanbul, Turkey, 34300
Istanbul, Turkey, 34365
Izmir, Turkey, 35100
Malatya, Turkey, 44280
S?hhiye, ANKARA, Turkey, 06100
United Kingdom
Birmingham, United Kingdom, B15 2TH
Bristol, United Kingdom, BS2 8ED
Cambridge, United Kingdom, CB2 0QQ
Cheltenham, United Kingdom, GL53 7AN
Glasgow, United Kingdom, G12 0YN
Lancaster, United Kingdom, LA1 4RP
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, E1 2AD
London, United Kingdom, SE1 7EH
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham, United Kingdom, NG5 1PB
Oxford, United Kingdom, OX3 7LJ
Scunthorpe, United Kingdom, DN16 7BH
Southampton, United Kingdom, SO16 6YD
Sutton, United Kingdom, SM2 5PT
Truro, United Kingdom, TR1 3LJ
Wirral, United Kingdom, L63 4JY
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services