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History of Changes for Study: NCT02420821
A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advance Renal Cell Carcinoma [IMmotion151]
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:  December 31, 2015 (v10)

Open or close this module Study Identification
Unique Protocol ID: WO29637
Brief Title: A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advance Renal Cell Carcinoma [IMmotion151]
Official Title:
Secondary IDs: 2014-004684-20 [EudraCT Number]
Open or close this module Study Status
Record Verification: December 2015
Overall Status: Recruiting
Study Start: May 2015
Primary Completion: June 2020 [Anticipated]
Study Completion: June 2020 [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:
December 31, 2015
Last Update Posted: January 1, 2016 [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 Atezolizumab (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: 830 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Atezolizumab + Bevacizumab
Patients assigned to a dual regimen of Atezolizumab plus Bevacizumab
Drug: Atezolizumab
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
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
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 Atezolizumab
[ 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 Atezolizumab
[ Time Frame: Post-dose on Day 1 Cycle 1 ]

20. Pharmacokinetics: Minimum serum concentration (Cmin) of Atezolizumab
[ 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 Atezolizumab 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
[Recruiting]
Tucson, Arizona, United States, 85724
United States, California
[Recruiting]
Orange, California, United States, 92868
[Active, not recruiting]
San Francisco, California, United States, 94143
United States, Colorado
[Active, not recruiting]
Aurora, Colorado, United States, 80045
[Active, not recruiting]
Denver, Colorado, United States, 80218
United States, District of Columbia
[Active, not recruiting]
Washington, District of Columbia, United States, 20016-1468
United States, Florida
[Active, not recruiting]
Boca Raton, Florida, United States, 33486
[Active, not recruiting]
Port Charlotte, Florida, United States, 33980
[Active, not recruiting]
St Petersburg, Florida, United States, 33705
[Recruiting]
West Palm Beach, Florida, United States, 33401
United States, Georgia
[Recruiting]
Atlanta, Georgia, United States, 30318
[Active, not recruiting]
Macon, Georgia, United States, 31201
[Recruiting]
Marietta, Georgia, United States, 30060
United States, Illinois
[Recruiting]
Chicago, Illinois, United States, 60637
United States, Kentucky
[Recruiting]
Louisville, Kentucky, United States, 40402
United States, Massachusetts
[Recruiting]
Boston, Massachusetts, United States, 02114
[Recruiting]
Boston, Massachusetts, United States, 02115
[Active, not recruiting]
Boston, Massachusetts, United States, 02215
United States, Nevada
[Active, not recruiting]
Las Vegas, Nevada, United States, 89169
United States, New Jersey
[Recruiting]
Hackensack, New Jersey, United States, 07601
United States, New York
[Recruiting]
Albany, New York, United States, 12208
[Active, not recruiting]
New York, New York, United States, 10065
United States, Ohio
[Recruiting]
Cincinnati, Ohio, United States, 45242
[Recruiting]
Cleveland, Ohio, United States, 44195
United States, Oregon
[Active, not recruiting]
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
[Active, not recruiting]
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
[Recruiting]
Chattanooga, Tennessee, United States, 37404
[Recruiting]
Nashville, Tennessee, United States, 37203
[Recruiting]
Nashville, Tennessee, United States, 37232
United States, Texas
[Active, not recruiting]
Dallas, Texas, United States, 75246
[Recruiting]
Fort Worth, Texas, United States, 76104
United States, Virginia
[Recruiting]
Raonoke, Virginia, United States, 24014
United States, Washington
[Recruiting]
Seattle, Washington, United States, 98109
Australia, New South Wales
[Recruiting]
Camperdown, New South Wales, Australia, 2050
[Recruiting]
Macquarie University, New South Wales, Australia, 2109
[Recruiting]
Waratah, New South Wales, Australia, 2298
Australia, Queensland
[Recruiting]
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
[Active, not recruiting]
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
[Recruiting]
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
[Recruiting]
Murdoch, Western Australia, Australia, WA6150
Bosnia and Herzegovina
[Not yet recruiting]
Banja Luka, Bosnia and Herzegovina, 78000
[Not yet recruiting]
Sarajevo, Bosnia and Herzegovina, 71000
Canada
[Active, not recruiting]
Quebec, Canada, G1R 3S1
Canada, Nova Scotia
[Recruiting]
Halifax, Nova Scotia, Canada, .B3H 2Y9
Canada, Ontario
[Active, not recruiting]
Barrie, Ontario, Canada, L4M 6M2
[Recruiting]
Hamilton, Ontario, Canada, L8V 5C2
[Not yet recruiting]
London, Ontario, Canada, N6A 4L6
[Recruiting]
Oshawa, Ontario, Canada, L1G 2B9
[Active, not recruiting]
Ottawa, Ontario, Canada, K1H 8L6
[Not yet recruiting]
Toronto, Ontario, Canada, M4N 3M5
[Not yet recruiting]
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
[Recruiting]
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
[Active, not recruiting]
Brno, Czech Republic, 656 53
[Recruiting]
Olomouc, Czech Republic, 775 20
[Recruiting]
Praha 4 - Krc, Czech Republic, 140 59
Denmark
[Recruiting]
Aarhus C, Denmark, 8000
[Recruiting]
Herlev, Denmark, 2730
[Recruiting]
Odense, Denmark, 5000
France
[Not yet recruiting]
Angers, France, 49055
[Not yet recruiting]
Bordeaux, France, 33075
[Not yet recruiting]
Caen, France, 14076
[Not yet recruiting]
Lille, France, 59020
[Not yet recruiting]
Lyon, France, 69373
[Not yet recruiting]
Nancy, France, 54100
[Not yet recruiting]
Paris, France, 75475
[Not yet recruiting]
Paris, France, 75908
[Not yet recruiting]
Villejuif, France, 94805
Germany
[Not yet recruiting]
Berlin, Germany, 10117
[Not yet recruiting]
Dresden, Germany, 01307
[Not yet recruiting]
Essen, Germany, 45122
[Not yet recruiting]
Heidelberg, Germany, 69120
[Not yet recruiting]
München, Germany, 81377
[Not yet recruiting]
Tübingen, Germany, 72076
Italy, Campania
[Recruiting]
Napoli, Campania, Italy, 80131
Italy, Emilia-Romagna
[Recruiting]
Meldola, Emilia-Romagna, Italy, 47014
[Recruiting]
Modena, Emilia-Romagna, Italy, 41100
Italy, Lazio
[Recruiting]
Roma, Lazio, Italy, 00152
Italy, Lombardia
[Recruiting]
Milano, Lombardia, Italy, 20132
[Recruiting]
Milano, Lombardia, Italy, 20162
[Recruiting]
Pavia, Lombardia, Italy, 27100
Italy, Toscana
[Recruiting]
Arezzo, Toscana, Italy, 52100
Japan
[Recruiting]
Aichi, Japan, 466-8560
[Recruiting]
Chiba, Japan, 260-0801
[Recruiting]
Ibaraki, Japan, 305-8576
[Recruiting]
Iwate, Japan, 020-8505
[Recruiting]
Kanagawa, Japan, 236-0004
[Recruiting]
Kumamoto, Japan, 860-8556
[Recruiting]
Niigata, Japan, 951-8520
[Recruiting]
Osaka, Japan, 537-8511
[Recruiting]
Osaka, Japan, 565-0871
[Recruiting]
Osaka, Japan, 589-8511
[Recruiting]
Sapporo-shi, Japan, 060-8648
[Recruiting]
Tokushima, Japan, 770-8503
[Recruiting]
Tokyo, Japan, 113-8603
[Recruiting]
Tokyo, Japan, 135-8550
[Recruiting]
Tokyo, Japan, 160-0016
[Recruiting]
Tokyo, Japan, 162-0054
Korea, Republic of
[Recruiting]
Daejeon, Korea, Republic of, 35015
[Recruiting]
Gyeonggi-do, Korea, Republic of, 10408
[Active, not recruiting]
Gyeonggi-do, Korea, Republic of, 13620
[Recruiting]
Seoul, Korea, Republic of, 03080
[Recruiting]
Seoul, Korea, Republic of, 03722
[Recruiting]
Seoul, Korea, Republic of, 05505
[Recruiting]
Seoul, Korea, Republic of, 06351
Mexico
[Recruiting]
Queretaro, Mexico, 76090
[Recruiting]
Toluca, Mexico, 50180
[Not yet recruiting]
Veracruz, Mexico, 91700
Poland
[Recruiting]
Lublin, Poland, 20-090
[Recruiting]
Poznan, Poland, 60-569
[Recruiting]
Warszawa, Poland, 04-125
Russian Federation
[Recruiting]
Moscow, Russian Federation, 125284
[Active, not recruiting]
Moscow, Russian Federation, 143423
[Active, not recruiting]
Nizhni Novgorod, Russian Federation, 603001
Serbia
[Not yet recruiting]
Belgrade, Serbia, 11000
[Not yet recruiting]
Sremska Kamenica, Serbia, 21204
Singapore
[Not yet recruiting]
Singapore, Singapore, 119074
[Not yet recruiting]
Singapore, Singapore, 169610
[Not yet recruiting]
Singapore, Singapore, 258499
Spain
[Recruiting]
Barcelona, Spain, 08035
[Recruiting]
Barcelona, Spain, 08036
[Recruiting]
Barcelona, Spain, 08907
[Recruiting]
Cordoba, Spain, 14004
[Recruiting]
Madrid, Spain, 28007
[Recruiting]
Madrid, Spain, 28034
[Active, not recruiting]
Madrid, Spain, 28041
[Recruiting]
Sevilla, Spain, 41013
Spain, Barcelona
[Recruiting]
Sabadell, Barcelona, Spain, 08208
Taiwan
[Recruiting]
Taichung, Taiwan, 407
[Recruiting]
Taipei, Taiwan, 100
[Active, not recruiting]
Taoyuan, Taiwan, 333
Turkey
[Recruiting]
Edirne, Turkey, 22770
[Recruiting]
Istanbul, Turkey, 34300
Ukraine
[Not yet recruiting]
Dnipropetrovsk, Ukraine, 49102
[Not yet recruiting]
Kiev, Ukraine, 04053
[Not yet recruiting]
Lviv, Ukraine, 79031
[Not yet recruiting]
Zaporizhzhia, Ukraine, 69600
United Kingdom
[Recruiting]
Bebington, United Kingdom, CH63 4JY
[Recruiting]
Birmingham, United Kingdom, B15 2TH
[Recruiting]
Blackburn, United Kingdom, BB2 3HH
[Recruiting]
Cambridge, United Kingdom, CB2 2QQ
[Recruiting]
London, United Kingdom, EC1A 7BE
[Recruiting]
London, United Kingdom, NW3 2QG
[Recruiting]
London, United Kingdom, SW3 6JJ
[Recruiting]
Manchester, United Kingdom, M2O 4BX
[Recruiting]
Oxford, United Kingdom, OX3 7LJ
[Recruiting]
Southampton, United Kingdom, SO16 6YD
[Recruiting]
Sutton, United Kingdom, SM2 5PT
[Recruiting]
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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