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Trial record 3 of 5 for:    Cabozantinib | advanced hepatocellular carcinoma

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy (COSMIC-312)

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ClinicalTrials.gov Identifier: NCT03755791
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Exelixis

Brief Summary:
This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Cabozantinib Drug: Sorafenib Drug: Atezolizumab Phase 3

Detailed Description:
This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in combination with atezolizumab versus sorafenib in adults with advanced HCC who have not received previous systemic anticancer therapy in the advanced HCC setting. The primary objective of this study is to evaluate the effect of cabozantinib in combination with atezolizumab on the duration of progression-free survival (PFS) and duration of overall survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of single-agent cabozantinib compared with sorafenib in this patient population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Approximately 740 eligible subjects with advanced HCC will be randomized in a 2:1:1 ratio. Experimental arm (approximately 370 subjects) will receive cabozantinib plus atezolizumab. Control arm (approximately 185 subjects) will receive sorafenib. Single-agent cabozantinib arm (approximately 185 subjects) will receive single-agent cabozantinib
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
Subjects with advanced HCC will receive cabozantinib 40 mg oral, qd + atezolizumab 1200 mg infusion, q3w
Drug: Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40 mg
Other Names:
  • XL184
  • Cabometyx®

Drug: Atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Name: Tecentriq®

Active Comparator: Control arm
Subjects with advanced HCC will receive sorafenib 400 mg bid (twice a day)
Drug: Sorafenib
Supplied as 200-mg tablets; administered orally twice daily at 400 mg
Other Name: Nexavar®

Single-Agent Cabozantinib arm
Subjects with advanced HCC will receive cabozantinib 60 mg qd
Drug: Cabozantinib
Supplied as 60-mg tablets; administered orally once daily at 60 mg
Other Names:
  • XL184
  • Cabometyx®




Primary Outcome Measures :
  1. Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm [ Time Frame: Up to 25 months after the first subject is randomized. Defined as time from randomization to the earlier of progressive disease (PD) per RECIST 1.1 as determined by the Blinded Independent Radiology Committee (BIRC) or death from any cause. ]
    Duration of PFS per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  2. Duration of Overall Survival (OS) for the experimental arm vs. the control arm [ Time Frame: Up to 38 months after the first subject is randomized. Defined as time from randomization to date of death from any cause. ]

Secondary Outcome Measures :
  1. Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm [ Time Frame: Up to 20 months after the first subject is randomized. ]
    Duration of PFS per RECIST 1.1 by BIRC



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines.
  • The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
  • Measurable disease per RECIST 1.1 as determined by the Investigator.
  • Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
  • Child-Pugh Score of A.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
  • Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors (ICIs). Subjects who have received local intratumoral or arterial chemotherapy are eligible; local anticancer therapy must be completed ≥ 28 days before randomization
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization.
  • Concomitant anticoagulation with oral anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755791


Contacts
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Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400

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Locations
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United States, Arizona
Exelixis Clinical Site #159 Recruiting
Tucson, Arizona, United States, 85719
United States, California
Exelixis Clinical Site #44 Recruiting
La Jolla, California, United States, 92037
Exelixis Clinical Site #112 Recruiting
Los Angeles, California, United States, 90033
Exelixis Clinical Site #2 Recruiting
Rialto, California, United States, 92377
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Exelixis Clinical Site #109 Recruiting
San Francisco, California, United States, 94115
Exelixis Clinical Site #54 Recruiting
San Francisco, California, United States, 94158
United States, District of Columbia
Exelixis Clinical Site #58 Recruiting
Washington, District of Columbia, United States, 20007
United States, Georgia
Exelixis Clinical Site #4 Recruiting
Atlanta, Georgia, United States, 30318
United States, Illinois
Exelixis Clinical Site #120 Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Exelixis Clinical Site #6 Recruiting
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Exelixis Clinical Site #7 Recruiting
Burlington, Massachusetts, United States, 01805
United States, Missouri
Exelixis Clinical Site #11 Recruiting
Kansas City, Missouri, United States, 64128
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Kansas City, Missouri, United States, 64131
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Saint Louis, Missouri, United States, 63110
United States, Nevada
Exelixis Clinical Site #1 Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Exelixis Clinical Site #14 Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
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Albuquerque, New Mexico, United States, 87131
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
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Toledo, Ohio, United States, 43614
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Portland, Oregon, United States, 97213
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Philadelphia, Pennsylvania, United States, 19107
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Charleston, South Carolina, United States, 29425
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Houston, Texas, United States, 77030
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Temple, Texas, United States, 76508
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Seattle, Washington, United States, 98101
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Seattle, Washington, United States, 98109
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Spokane, Washington, United States, 99208
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Australia, New South Wales
Exelixis Clinical Site #78 Recruiting
Camperdown, New South Wales, Australia, 2050
Exelixis Clinical Site #165 Recruiting
Darlinghurst, New South Wales, Australia, 2010
Exelixis Clinical Site #171 Recruiting
Kingswood, New South Wales, Australia, 2747
Exelixis Clinical Site #126 Recruiting
Kogarah, New South Wales, Australia, 2217
Exelixis Clinical Site #155 Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Exelixis Clinical Site #142 Recruiting
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
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Kurralta Park, South Australia, Australia
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Heidelberg, Victoria, Australia, 3084
Exelixis Clinical Site #72 Recruiting
Parkville, Victoria, Australia, 3050
Austria
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Klagenfurt, Kärnten, Austria, 9020
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St. Pölten, Lower Austria, Austria, 3100
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Linz, Oberosterreich, Austria, 4010
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Wien, Austria, 1090
Belgium
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Brussels, California, Belgium, 1070
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Brussels, Belgium, 1200
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Gent, Belgium, 9000
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Haine-Saint-Paul, Belgium, 7100
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Liège, Belgium, 4000
Brazil
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Belo Horizonte, MG, Brazil, 30110-022
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Belo Horizonte, MG, Brazil, 30130-090
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Curitiba, PR, Brazil, 81520-060
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Barretos, SP, Brazil, 14784-400
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Jaú, SP, Brazil, 17210-120
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São Paulo, SP, Brazil, 01321-001
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São Paulo, SP, Brazil, 04538-132
Exelixis Clinical Site #91 Recruiting
São Paulo, Brazil, 04543-000
Canada, Alberta
Exelixis Clinical Site #71 Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Exelixis Clinical Site #34 Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Quebec
Exelixis Clinical Site #85 Recruiting
Montréal, Quebec, Canada, H3T 1E2
Colombia
Exelixis Clinical Site #130 Recruiting
Montería, Cordoba, Colombia, 230002
Czechia
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Hradec Králové, Czechia, 500 05
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Olomouc, Czechia, 779 00
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Praha 4, Czechia, 140 59
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Praha 5, Czechia, 150 06
France
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Amiens, France, 80054
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Besancon, France, 25030
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Bondy Cedex, France, 93140
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Caen Cedex 09, France, 14033
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Clichy, France, 92110
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Grenoble, France, 38043
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Lille Cedex, France, 59037
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Lyon Cedex 4, France, 69317
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Montbeliard, France, 25250
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Montpellier, France, 34295
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Nantes, France, 44093
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Nice, France, 06202
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Pessac, France, 33604
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Vandœuvre-lès-Nancy, France, 54511
Georgia
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Batumi, Georgia, 6000
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Tbilisi, Georgia, 0112
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Tbilisi, Georgia, 0114
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Tbilisi, Georgia, 0144
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Tbilisi, Georgia, 0186
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Hungary
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Budapest, Hungary, 1083
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Debrecen, Hungary, 4032
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Szeged, Hungary, 6720
Ireland
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Dublin, Ireland, 8
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Jerusalem, Israel, 9112001
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Petah Tikva, Israel, 4941492
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Ramat-Gan, Israel, 5262101
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Rehovot, Israel, 7661041
Italy
Exelixis Clinical Site #163 Recruiting
Tricase, Lecce, Italy, 73039
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Rozzano, Milano, Italy, 20089
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Bologna, Italy, 40138
Exelixis Clinical Site #152 Recruiting
Brescia, Italy, 25124
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Milan, Italy, 20122
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Napoli, Italy, 80131
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Novara, Italy, 28100
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Roma, Italy, 00168
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Torino, Italy, 10126
Exelixis Clinical Site #182 Recruiting
Torino, Italy, 10128
Korea, Republic of
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
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Suwon, Gyeonggi-do, Korea, Republic of, 16499
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Busan, Korea, Republic of, 47392
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Busan, Korea, Republic of, 49201
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Busan, Korea, Republic of, 49241
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Incheon, Korea, Republic of, 22332
Exelixis Clinical Site #104 Recruiting
Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 03080
Exelixis Clinical Site #99 Recruiting
Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06273
Exelixis Clinical Site #93 Recruiting
Seoul, Korea, Republic of, 06351
Mexico
Exelixis Clinical Site #141 Recruiting
Tuxtla Gutiérrez, Chiapas, Mexico, 29038
Exelixis Clinical Site #135 Recruiting
León, Guanajuato, Mexico, 37000
Exelixis Clinical Site #132 Recruiting
Monterrey, Nuevo Leon, Mexico, 64000
Exelixis Clinical Site #133 Recruiting
Ciudad De México, Mexico, 06700
Exelixis Clinical Site #160 Recruiting
Mexico City, Mexico, 06760
Exelixis Clinical Site #134 Recruiting
San Luis Potosí, Mexico, 78250
Exelixis Clinical Site #153 Recruiting
Veracruz, Mexico, 94300
Netherlands
Exelixis Clinical Site #92 Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
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Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Exelixis Clinical Site #84 Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Exelixis Clinical Site #36 Recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
Exelixis Clinical Site #60 Recruiting
Grafton, Auckland, New Zealand, 1023
Exelixis Clinical Site #62 Recruiting
Newton, Wellington, New Zealand, 6021
Philippines
Exelixis Clinical Site #118 Recruiting
Cebu City, Philippines, 6000
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Pasig City, Philippines, 1605
Exelixis Clinical Site #136 Recruiting
Quezon City, Philippines, 1102
Poland
Exelixis Clinical Site #41 Recruiting
Warszawa, Mazowieckie, Poland, 02-507
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Gdansk, Pomorskie, Poland, 80-952
Exelixis Clinical Site #15 Recruiting
Mysłowice, Slaskie, Poland, 41-400
Russian Federation
Exelixis Clinical Site #74 Recruiting
Kislino, Kursk Region, Russian Federation, 305524
Exelixis Clinical Site #81 Recruiting
Kaluga, Russian Federation, 248007
Exelixis Clinical Site #95 Recruiting
Krasnodar, Russian Federation, 350040
Exelixis Clinical Site #108 Recruiting
Moscow, Russian Federation, 115478
Exelixis Clinical Site #101 Recruiting
Murmansk, Russian Federation, 183047
Exelixis Clinical Site #80 Recruiting
Nizhny Novgorod, Russian Federation, 603137
Exelixis Clinical Site #111 Recruiting
Saint Petersburg, Russian Federation, 197758
Exelixis Clinical Site #90 Recruiting
Saint-Petersburg, Russian Federation, 197758
Exelixis Clinical Site #73 Recruiting
Sochi, Russian Federation, 354057
Singapore
Exelixis Clinical Site #106 Recruiting
Singapore, Singapore, 169610
Exelixis Clinical Site #97 Recruiting
Singapore, Singapore, 217562
Exelixis Clinical Site #116 Recruiting
Singapore, Singapore, 308433
Spain
Exelixis Clinical Site #28 Recruiting
Santander, Cantabria, Spain, 39008
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Majadahonda, Madrid, Spain, 28222
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Majadahonda, Madrid, Spain, 28222
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Pamplona, Navarra, Spain, 31008
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Barcelona, Spain, 08908
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Madrid, Spain, 28007
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Madrid, Spain, 28046
Exelixis Clinical Site #168 Recruiting
Valencia, Spain, 46009
Exelixis Clinical Site #45 Recruiting
Zaragoza, Spain, 50009
Switzerland
Exelixis Clinical Site #115 Recruiting
Basel, Switzerland, 4031
Exelixis Clinical Site #172 Recruiting
Bern, Switzerland, 3010
Exelixis Clinical Site #110 Recruiting
Saint Gallen, Switzerland, 9007
Exelixis Clinical Site #61 Recruiting
Zurich, Switzerland, 8091
Taiwan
Exelixis Clinical Site #119 Recruiting
Changhua, Taiwan, 500
Exelixis Clinical Site #162 Recruiting
Kaohsiung, Taiwan, 833
Exelixis Clinical Site #161 Recruiting
Taichung, Taiwan, 407
Exelixis Clinical Site #145 Recruiting
Tainan, Taiwan, 736
Exelixis Clinical Site #82 Recruiting
Taipei, Taiwan, 10002
Exelixis Clinical Site #128 Recruiting
Taipei, Taiwan, 10491
Exelixisi Clinical Site #100 Recruiting
Taipei, Taiwan, 11217
Exelixis Clinical Site #94 Recruiting
Taoyuan, Taiwan, 333
Thailand
Exelixis Clinical Site #96 Recruiting
Pathum Wan, Bangkok, Thailand, 10330
Exelixis Clinical Site #183 Recruiting
Muang, Khon Kaen, Thailand, 40002
Exelixis Clinical Site #139 Recruiting
Hat Yai, Songkla, Thailand, 90110
Exelixis Clinical Site #143 Recruiting
Chiang Mai, Thailand, 50200
Turkey
Exelixis Clinical Site #178 Recruiting
Ankara, Turkey, 06230
Exelixis Clinical Site #173 Recruiting
Edirne, Turkey, 22030
Exelixis Clinical Site #179 Recruiting
Istanbul, Turkey, 34214
Exelixis Clinical Site #180 Recruiting
Malatya, Turkey, 44280
Ukraine
Exelixis Clinical Site #125 Recruiting
Chernivtsi, Ukraine, 58013
Exelixis Clinical Site #122 Recruiting
Dnipro, Ukraine, 49102
Exelixis Clinical Site #123 Recruiting
Kharkiv, Ukraine, 61070
Exelixis Clinical Site #124 Recruiting
Odesa, Ukraine, 65055
Exelixis Clinical Site #138 Recruiting
Uzhhorod, Ukraine, 88000
United Kingdom
Exelixis Clinical Site #83 Recruiting
Bristol, England, United Kingdom, BS2 8ED
Exelixis Clinical Site #87 Recruiting
Cambridge, England, United Kingdom, CB2 0QQ
Exelixis Clinical Site #151 Recruiting
London, England, United Kingdom, NW3 2QG
Exelixis Clinical Site #129 Recruiting
London, England, United Kingdom, W12 0HS
Sponsors and Collaborators
Exelixis

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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT03755791     History of Changes
Other Study ID Numbers: XL184-312
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exelixis:
liver
cancer
hepatocellular
carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs