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History of Changes for Study: NCT02420821
A Study of MPDL3280A (Anti-Programmed Death Ligand 1 [PD-L1] Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Latest version (submitted January 4, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 15, 2015 None (earliest Version on record)
2 May 11, 2015 Recruitment Status, Contacts/Locations and Study Status
3 May 29, 2015 Contacts/Locations and Study Status
4 June 1, 2015 Study Status
5 September 14, 2015 Contacts/Locations, Arms and Interventions, Study Status, Eligibility, Outcome Measures, Study Description and Study Identification
6 September 17, 2015 Contacts/Locations, Study Status and Study Identification
7 October 1, 2015 Contacts/Locations and Study Status
8 November 2, 2015 Contacts/Locations and Study Status
9 December 1, 2015 Contacts/Locations and Study Status
10 December 31, 2015 Contacts/Locations, Study Design and Study Status
11 February 11, 2016 Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status, Study Identification, Eligibility and Study Description
12 March 1, 2016 Contacts/Locations and Study Status
13 April 2, 2016 Contacts/Locations and Study Status
14 May 4, 2016 Contacts/Locations and Study Status
15 June 1, 2016 Contacts/Locations and Study Status
16 July 1, 2016 Study Status, Contacts/Locations and Study Design
17 August 1, 2016 Contacts/Locations and Study Status
18 August 15, 2016 Contacts/Locations, Arms and Interventions and Study Status
19 September 1, 2016 Contacts/Locations and Study Status
20 October 3, 2016 Contacts/Locations and Study Status
21 November 1, 2016 Contacts/Locations and Study Status
22 February 28, 2017 Recruitment Status, Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Study Design, Study Identification, Eligibility and Study Description
23 April 5, 2017 Study Status and Contacts/Locations
24 May 5, 2017 Contacts/Locations and Study Status
25 July 13, 2017 Contacts/Locations and Study Status
26 August 1, 2017 Study Status
27 January 8, 2018 Contacts/Locations and Study Status
28 January 12, 2018 Study Status
29 January 17, 2018 Study Status
30 February 28, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
31 March 14, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
32 April 2, 2018 Study Status and Contacts/Locations
33 April 23, 2018 Study Status
34 May 7, 2018 Study Status
35 June 4, 2018 Study Status
36 June 18, 2018 Study Status and Contacts/Locations
37 June 26, 2018 Study Status
38 July 30, 2018 Outcome Measures, Arms and Interventions, Study Status, Study Identification, Contacts/Locations, Eligibility and Study Description
Show
Results Submission Events
39 September 4, 2018 Study Status, Outcome Measures, Contacts/Locations, Document Section and Results
40 November 26, 2018 Study Status
41 February 18, 2019 Study Status and Contacts/Locations
42 February 21, 2019 Study Status
43 May 13, 2019 Study Status and Contacts/Locations
44 August 5, 2019 Contacts/Locations and Study Status
45 September 9, 2019 Study Status and Contacts/Locations
46 September 16, 2019 Study Status
47 October 14, 2019 Study Status and Contacts/Locations
48 October 22, 2019 Contacts/Locations and Study Status
49 January 13, 2020 Study Status and Contacts/Locations
50 March 4, 2020 Study Status and Contacts/Locations
51 May 26, 2020 Contacts/Locations and Study Status
52 August 17, 2020 Contacts/Locations and Study Status
53 September 14, 2020 Study Status and Contacts/Locations
54 October 13, 2020 Study Status
55 January 20, 2021 Contacts/Locations and Study Status
56 March 18, 2021 Study Status and Contacts/Locations
57 May 6, 2021 Study Status
58 July 27, 2021 Study Status and Contacts/Locations
59 October 19, 2021 Contacts/Locations and Study Status
60 January 13, 2022 Recruitment Status, Study Status and Contacts/Locations
61 January 4, 2023 Adverse Events, Outcome Measures, Participant Flow, Study Status, Contacts/Locations and More Information
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Study NCT02420821
Submitted Date:  April 15, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: WO29637
Brief Title: A Study of MPDL3280A (Anti-Programmed Death Ligand 1 [PD-L1] Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Official Title:
Secondary IDs: 2014-004684-20 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Not yet recruiting
Study Start: May 2015
Primary Completion: September 2019 [Anticipated]
Study Completion: September 2019 [Anticipated]
First Submitted: April 15, 2015
First Submitted that
Met QC Criteria:
April 15, 2015
First Posted: April 20, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 15, 2015
Last Update Posted: April 20, 2015 [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 randomized, open-label study is designed to evaluate the efficacy of MPDL3280A (anti-PD-L1 antibody) plus bevacizumab versus sunitinib in patients with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.
Detailed Description:
Open or close this module Conditions
Conditions: Renal Cell Carcinoma
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: 550 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MPDL3280A + Bevacizumab
Patients assigned to a dual regimen of MPDL3280A plus bevacizumab
Drug: Bevacizumab
15 mg/kg IV infusion on Days 1 and 22 of each 42-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death
Drug: MPDL3280A
Fixed-dose 1200 mg IV infusion on Days 1 and 22 of each 42-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death
Experimental: Sunitinib
Patients assigned to receive sunitinib single-agent chemotherapy
Drug: Sunitinib
50 mg orally (PO) once daily on Days 1 through 28 of each 42-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
[ Time Frame: Up to approximately 2.5 years ]

Secondary Outcome Measures:
1. Overall survival (OS)
[ Time Frame: Up to approximately 4 years ]

2. Objective response rate (ORR) as determined by the investigator using RECIST v1.1 criteria
[ Time Frame: Up to approximately 3 years ]

3. Time to deterioration (TTD) in patient-reported tiredness severity score
[ Time Frame: Up to approximately 3 years ]

4. Change from baseline in diarrhea severity
[ Time Frame: Up to approximately 3 years ]

5. Change from baseline in functional interference from fatigue
[ Time Frame: Up to approximately 3 years ]

6. Change from baseline in functional interference from symptoms
[ Time Frame: Up to approximately 3 years ]

7. Change from baseline in treatment side effects subscale
[ Time Frame: Up to approximately 3 years ]

8. PFS as determined by an independent review committee (IRC) using RECIST v1.1
[ Time Frame: Up to approximately 3 years ]

9. Duration of response (DOR) as determined by the investigator using RECIST v1.1
[ Time Frame: Up to approximately 3 years ]

10. ORR as determined by an IRC using RECIST v1.1
[ Time Frame: Up to approximately 3 years ]

11. DOR as determined by an IRC using RECIST v1.1
[ Time Frame: Up to approximately 3 years ]

12. PFS as determined by the investigator using modified RECIST criteria
[ Time Frame: Up to approximately 3 years ]

13. DOR as determined by the investigator using modified RECIST criteria
[ Time Frame: Up to approximately 3 years ]

14. ORR as determined by the investigator using modified RECIST criteria
[ Time Frame: Up to approximately 3 years ]

15. OS in patients with detectable programmed death ligand 1 (PDL1) expression
[ Time Frame: Up to approximately 3 years ]

16. PFS as determined by the investigator using RECIST v1.1 in patients with detectable PDL1 expression
[ Time Frame: Up to approximately 3 years ]

17. Safety: Incidence of adverse events
[ Time Frame: From the start of treatment until a maximum of 42 days after the last dose of study treatment ]

18. Safety: Incidence of anti-therapeutic antibodies (ATAs) against MPDL3280A
[ Time Frame: From the start of treatment until approximately 120 days after the last dose of study treatment ]

19. Pharmacokinetics: Maximum serum concentration (Cmax) of MPDL3280A
[ Time Frame: Post-dose on Day 1 Cycle 1 ]

20. Pharmacokinetics: Minimum serum concentration (Cmin) of MPDL3280A
[ Time Frame: From the start of treatment until approximately 120 days after the last dose of study treatment ]

21. Pharmacokinetics: Cmax of bevacizumab
[ Time Frame: Post-dose on Day 1 Cycle 1 ]

22. Pharmacokinetics: Cmin of bevacizumab
[ Time Frame: From the start of treatment until a maximum of 30 days after the last dose of study treatment ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients 18 years of age or older
  • Definitive diagnosis of unresectable advanced or metastatic RCC with clear-cell histology and/or sarcomatoid carcinoma
  • Evaluable Memorial Sloan Kettering Cancer Center (MSKCC) risk score
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Karnofsky performance status (KPS) greater than or equal to 70
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Radiotherapy for RCC within 14 days prior to treatment
  • Active or untreated central nervous system (CNS) metastases
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled hypercalcemia
  • Any other malignancies within 5 years except those with negligible risk of metastasis or death
  • Life expectancy less than 12 weeks
  • Participation in another experimental drug study within 4 weeks prior to treatment
  • Pregnant or lactating women
  • Known hypersensitivity to any component of MPDL3280A or other study medication
  • History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
  • Positive human immunodeficiency virus (HIV) test
  • Active hepatitis B or C
  • Severe infection within 4 weeks prior to treatment
  • Exposure to oral or intravenous (IV) antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to treatment
  • Significant cardiovascular disease
  • Prior allogeneic bone marrow or solid organ transplantation
  • Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
  • Treatment with immunostimulatory agents within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment
  • History of hypertensive crisis or hypertensive encephalopathy
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: WO29637 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, Arizona
Tucson, Arizona, United States, 85724
United States, California
Los Angeles, California, United States, 90095
Orange, California, United States, 92868
San Francisco, California, United States, 94143
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80218
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington, District of Columbia, United States, 20016-1468
United States, Florida
St Petersburg, Florida, United States, 33705
United States, Georgia
Atlanta, Georgia, United States, 30318
Macon, Georgia, United States, 31201
Marietta, Georgia, United States, 30060
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kentucky
Louisville, Kentucky, United States, 40402
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Morristown, New Jersey, United States, 07960
United States, New York
Hudson, New York, United States, 12534
New York, New York, United States, 10065
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oregon
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Nashville, Tennessee, United States, 37203
Nashville, Tennessee, United States, 37232
United States, Texas
Fort Worth, Texas, United States, 76104
United States, Virginia
Charlottesville, Virginia, United States, 22906
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle, Washington, United States, 98109
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Macquarie University, New South Wales, Australia, 2109
Newcastle, New South Wales, Australia, 2298
Australia, Queensland
Milton, Queensland, Australia, 4064
Australia, South Australia
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Murdoch, Western Australia, Australia, WA6150
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Barrie, Ontario, Canada, L4M 6M2
Hamilton, Ontario, Canada, L8V 5C2
Oshawa, Ontario, Canada, L1G 2B9
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Denmark
Aarhus C, Denmark, 8000
Herlev, Denmark, 2730
Odense, Denmark, 5000
Italy, Campania
Napoli, Campania, Italy, 80131
Italy, Emilia-Romagna
Meldola, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41100
Italy, Lazio
Roma, Lazio, Italy, 00152
Italy, Lombardia
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20162
Pavia, Lombardia, Italy, 27100
Italy, Toscana
Arezzo, Toscana, Italy, 52100
Korea, Republic of
Daejeon, Korea, Republic of, 301-721
Gyeonggi-do, Korea, Republic of, 410-769
Seongnam-si, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 110-774
Seoul, Korea, Republic of, 120-749
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Russian Federation
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 143423
Nizhni Novgorod, Russian Federation, 603001
Taiwan
Taichung, Taiwan, 407
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Turkey
Edirne, Turkey, 22770
Istanbul, Turkey, 34300
United Kingdom
Bebington, United Kingdom, CH63 4JY
Birmingham, United Kingdom, B15 2TH
Cambridge, United Kingdom, CB2 2QQ
London, United Kingdom, EC1A 7BE
London, United Kingdom, NW3 2QG
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M2O 4BX
Oxford, United Kingdom, OX3 7LJ
Preston, United Kingdom, PR2 9HT
Southampton, United Kingdom, SO16 6YD
Sutton, United Kingdom, SM2 5PT
Swansea, United Kingdom, SA2 8QA
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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