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Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313)

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cabozantinib
Nivolumab
Ipilimumab
Cabozantinib-matched placebo
Sponsored by
Exelixis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring renal, cancer, carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
  • Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria.
  • Measurable disease per RECIST 1.1 as determined by the Investigator. Measurable disease must be outside the radiation field if radiation therapy was previously administered.
  • Karnofsky Performance Status (KPS) ≥ 70%.
  • Adequate organ and marrow function.

Exclusion Criteria:

  • Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents.
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and stable for at least 4 weeks prior to randomization.
  • Concomitant anticoagulation with oral anticoagulants or platelet inhibitors.
  • Administration of a live, attenuated vaccine within 30 days prior to randomization.
  • Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesions invading major pulmonary blood vessels.

  • Other clinically significant disorders such as:

    • Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization.
    • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.
    • Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active myobacterial infection.
    • Known history of COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to randomization.
  • Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major or minor surgery before randomization.
  • Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Sites / Locations

  • Exelixis Clinical Site #116
  • Exelixis Clinical Site #166
  • Exelixis Clinical Site #58B
  • Exelixis Clinical Site #29
  • Exelixis Clinical Site #44
  • Exelixis Clinical Site #3
  • Exelixis Clinical Site #95
  • Exelixis Clinical Site #69
  • Exelixis Clinical Site #58A
  • Exelixis Clinical Site #7B
  • Exelixis Clinical Site #7A
  • Exelixis Clinical Site #7C
  • Exelixis Clinical Site #6
  • Exelixis Clinical Site #15
  • Exelixis Clinical Site #24
  • Exelixis Clinical Site #4
  • Exelixis Clinical Site #2
  • Exelixis Clinical Site #159
  • Exelixis Clinical Site #8
  • Exelixis Clinical Site #19
  • Exelixis Clinical Site #101
  • Exelixis Clinical Site #107
  • Exelixis Clinical Site #12
  • Exelixis Clinical Site #102
  • Exelixis Clinical Site #5
  • Exelixis Clinical Site #10
  • Exelixis Clinical Site #38
  • Exelixis Clinical Site #64
  • Exelixis Clinical Site #57
  • Exelixis Clinical Site #1
  • Exelixis Clinical Site #13
  • Exelixis Clinical Site #153
  • Exelixis Clinical Site #109
  • Exelixis Clinical Site #73
  • Exelixis Clinical Site #63
  • Exelixis Clinical Site #54
  • Exelixis Clinical Site #110
  • Exelixis Clinical Site #120
  • Exelixis Clinical Site #32
  • Exelixis Clinical Site #35
  • Exelixis Clinical Site #27
  • Exelixis Clinical Site #33
  • Exelixis Clinical Site #17
  • Exelixis Clinical Site #14
  • Exelixis Clinical Site #18
  • Exelixis Clinical Site #11
  • Exelixis Clinical Site #9
  • Exelixis Clinical Site #23
  • Exelixis Clinical Site #26
  • Exelixis Clinical Site #98
  • Exelixis Clinical Site #76
  • Exelixis Clinical Site #75
  • Exelixis Clinical Site #126
  • Exelixis Clinical Site #112
  • Exelixis Clinical Site #146
  • Exelixis Clinical Site #154
  • Exelixis Clinical Site #155
  • Exelixis Clinical Site #140
  • Exelixis Clinical Site #163
  • Exelixis Clinical Site #158
  • Exelixis Clinical Site #168
  • Exelixis Clinical Site #162
  • Exelixis Clinical Site #119
  • Exelixis Clinical Site #141
  • Exelixis Clinical Site #22
  • Exelixis Clinical Site #105
  • Exelixis Clinical Site #46
  • Exelixis Clinical Site #25
  • Exelixis Clinical Site #113
  • Exelixis Clinical Site #85
  • Exelixis Clinical Site #91
  • Exelixis Clinical Site #100
  • Exelixis Clinical Site #89
  • Exelixis Clinical Site #114
  • Exelixis Clinical Site #118
  • Exelixis Clinical Site #50
  • Exelixis Clinical Site #56
  • Exelixis Clinical Site #52
  • Exelixis Clinical Site #86
  • Exelixis Clinical Site #71
  • Exelixis Clinical Site #78
  • Exelixis Clinical Site #80
  • Exelixis Clinical Site #66
  • Exelixis Clinical Site #150
  • Exelixis Clinical Site #65
  • Exelixis Clinical Site #125
  • Exelixis Clinical Site #128
  • Exelixis Clinical Site #90
  • Exelixis Clinical Site #42
  • Exelixis Clinical Site #67
  • Exelixis Clinical Site #37
  • Exelixis Clinical Site #127
  • Exelixis Clinical Site #115
  • Exelixis Clinical Site #117
  • Exelixis Clinical Site #139
  • Exelixis Clinical Site #171
  • Exelixis Clinical Site #164
  • Exelixis Clinical Site #137
  • Exelixis Clinical Site #124
  • Exelixis Clinical Site #28
  • Exelixis Clinical Site #136
  • Exelixis Clinical Site #111
  • Exelixis Clinical Site #39
  • Exelixis Clinical Site #51
  • Exelixis Clinical Site #88
  • Exelixis Clinical Site #81
  • Exelixis Clinical Site #84
  • Exelixis Clinical Site #121
  • Exelixis Clinical Site #97
  • Exelixis Clincal Site #129
  • Exelixis Clinical Site #41
  • Exelixis Clinical Site #70
  • Exelixis Clinical Site #47
  • Exelixis Clinical Site #60
  • Exelixis Clinical Site #61
  • Exelixis Clinical Site #59
  • Exelixis Clinical Site #104
  • Exelixis Clinical Site #68
  • Exelixis Clinical Site #147
  • Exelixis Clinical Site #143
  • Exelixis Clinical Site #151
  • Exelixis Clinical Site #152
  • Exelixis Clinical Site #123
  • Exelixis Clinical Site #167
  • Exelixis Clinical Site #169
  • Exelixis Clinical Site #134
  • Exelixis Clinical Site #132
  • Exelixis Clinical Site #160
  • Exelixis Clinical Site #131
  • Exelixis Clinical Site #161
  • Exelixis Clinical Site #144
  • Exelixis Clinical Site #149
  • Exelixis Clinical Site #122
  • Exelixis Clinical Site #148
  • Exelixis Clinical Site #31
  • Exelixis Clinical Site #62
  • Exelixis Clinical Site #135
  • Exelixis Clinical Site #99
  • Exelixis Clinical Site #83
  • Exelixis Clinical Site #77
  • Exelixis Clinical Site #40
  • Exelixis Clinical Site #53
  • Exelixis Clinical Site #45
  • Exelixis Clinical Site #43
  • Exelixis Clinical Site #36
  • Exelixis Clinical Site #49
  • Exelixis Clinical Site #34
  • Exelixis Clinical Site #94
  • Exelixis Clinical Site #20
  • Exelixis Clinical Site #55
  • Exelixis Clinical Site #96
  • Exelixis Clinical Site #74
  • Exelixis Clinical Site #142
  • Exelixis Clinical Site #138
  • Exelixis Clinical Site #173
  • Exelixis Clinical Site #72
  • Exelixis Clinical Site #93
  • Exelixis Clinical Site #30
  • Exelixis Clinical Site #172
  • Exelixis Clinical Site #92

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm

Control Arm

Arm Description

Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab

Cabozantinib-matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib-matched placebo + nivolumab

Outcomes

Primary Outcome Measures

Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC)

Secondary Outcome Measures

Duration of Overall Survival (OS)

Full Information

First Posted
May 2, 2019
Last Updated
April 11, 2023
Sponsor
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT03937219
Brief Title
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Acronym
COSMIC-313
Official Title
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
Detailed Description
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. The primary objective of this study is to evaluate the effect of cabozantinib in combination with nivolumab and ipilimumab ("triplet") on the duration of progression-free survival (PFS) versus nivolumab and ipilimumab. A secondary objective is to evaluate the effect of triplet combination on the duration of overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
renal, cancer, carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Cabozantinib-matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib-matched placebo + nivolumab
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Other Intervention Name(s)
Cabometyx, XL184
Intervention Description
Specified dose on specified days.
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days.
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Intervention Description
Specified dose on specified days.
Intervention Type
Drug
Intervention Name(s)
Cabozantinib-matched placebo
Intervention Description
Specified dose on specified days.
Primary Outcome Measure Information:
Title
Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC)
Time Frame
Up to 23 months after first subject randomized
Secondary Outcome Measure Information:
Title
Duration of Overall Survival (OS)
Time Frame
Up to 69 months after first subject randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component. Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria. Measurable disease per RECIST 1.1 as determined by the Investigator. Measurable disease must be outside the radiation field if radiation therapy was previously administered. Karnofsky Performance Status (KPS) ≥ 70%. Adequate organ and marrow function. Exclusion Criteria: Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to randomization. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and stable for at least 4 weeks prior to randomization. Concomitant anticoagulation with oral anticoagulants or platelet inhibitors. Administration of a live, attenuated vaccine within 30 days prior to randomization. Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesions invading major pulmonary blood vessels. Other clinically significant disorders such as: Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active myobacterial infection. Known history of COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to randomization. Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major or minor surgery before randomization. Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
Facility Information:
Facility Name
Exelixis Clinical Site #116
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Exelixis Clinical Site #166
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
Exelixis Clinical Site #58B
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Exelixis Clinical Site #29
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Exelixis Clinical Site #44
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Exelixis Clinical Site #3
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Exelixis Clinical Site #95
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Exelixis Clinical Site #69
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Exelixis Clinical Site #58A
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Exelixis Clinical Site #7B
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Exelixis Clinical Site #7A
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Exelixis Clinical Site #7C
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Exelixis Clinical Site #6
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Exelixis Clinical Site #15
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Exelixis Clinical Site #24
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Exelixis Clinical Site #4
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Exelixis Clinical Site #2
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Exelixis Clinical Site #159
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Exelixis Clinical Site #8
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Exelixis Clinical Site #19
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Exelixis Clinical Site #101
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Exelixis Clinical Site #107
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Exelixis Clinical Site #12
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Exelixis Clinical Site #102
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Exelixis Clinical Site #5
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Exelixis Clinical Site #10
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Exelixis Clinical Site #38
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Exelixis Clinical Site #64
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Exelixis Clinical Site #57
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Exelixis Clinical Site #1
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Exelixis Clinical Site #13
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Exelixis Clinical Site #153
City
Pilar
State/Province
Provincia De Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Exelixis Clinical Site #109
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Exelixis Clinical Site #73
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000
Country
Argentina
Facility Name
Exelixis Clinical Site #63
City
Caba
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Exelixis Clinical Site #54
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Exelixis Clinical Site #110
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Exelixis Clinical Site #120
City
Córdoba
ZIP/Postal Code
X5004
Country
Argentina
Facility Name
Exelixis Clinical Site #32
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Exelixis Clinical Site #35
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Exelixis Clinical Site #27
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Exelixis Clinical Site #33
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Exelixis Clinical Site #17
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Exelixis Clinical Site #14
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Exelixis Clinical Site #18
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Exelixis Clinical Site #11
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Exelixis Clinical Site #9
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Exelixis Clinical Site #23
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Exelixis Clinical Site #26
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Exelixis Clinical Site #98
City
Wiener Neustadt
State/Province
Niederösterreich
ZIP/Postal Code
2700
Country
Austria
Facility Name
Exelixis Clinical Site #76
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Exelixis Clinical Site #75
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Exelixis Clinical Site #126
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Exelixis Clinical Site #112
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Exelixis Clinical Site #146
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Exelixis Clinical Site #154
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Exelixis Clinical Site #155
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Exelixis Clinical Site #140
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Exelixis Clinical Site #163
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Exelixis Clinical Site #158
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Exelixis Clinical Site #168
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Exelixis Clinical Site #162
City
São José Do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Exelixis Clinical Site #119
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Exelixis Clinical Site #141
City
São Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Exelixis Clinical Site #22
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Exelixis Clinical Site #105
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Exelixis Clinical Site #46
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Exelixis Clinical Site #25
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Exelixis Clinical Site #113
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Exelixis Clinical Site #85
City
Temuco
State/Province
Región De La Araucanía (IX)
ZIP/Postal Code
4810561
Country
Chile
Facility Name
Exelixis Clinical Site #91
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Exelixis Clinical Site #100
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Exelixis Clinical Site #89
City
Králová
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Exelixis Clinical Site #114
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Exelixis Clinical Site #118
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Exelixis Clinical Site #50
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Exelixis Clinical Site #56
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Exelixis Clinical Site #52
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Exelixis Clinical Site #86
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Exelixis Clinical Site #71
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Exelixis Clinical Site #78
City
Lyon Cedex 8
ZIP/Postal Code
69373
Country
France
Facility Name
Exelixis Clinical Site #80
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Exelixis Clinical Site #66
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Exelixis Clinical Site #150
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Exelixis Clinical Site #65
City
Reims Cedex
ZIP/Postal Code
51726
Country
France
Facility Name
Exelixis Clinical Site #125
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Exelixis Clinical Site #128
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Exelixis Clinical Site #90
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Exelixis Clinical Site #42
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Exelixis Clinical Site #67
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Exelixis Clinical Site #37
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Exelixis Clinical Site #127
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Exelixis Clinical Site #115
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Exelixis Clinical Site #117
City
Frankfurt am main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Exelixis Clinical Site #139
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Exelixis Clinical Site #171
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
90419
Country
Germany
Facility Name
Exelixis Clinical Site #164
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Exelixis Clinical Site #137
City
Jena
State/Province
Thüringen
ZIP/Postal Code
077477
Country
Germany
Facility Name
Exelixis Clinical Site #124
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Exelixis Clinical Site #28
City
Hong Kong
Country
Hong Kong
Facility Name
Exelixis Clinical Site #136
City
Shatin
Country
Hong Kong
Facility Name
Exelixis Clinical Site #111
City
Tuen Mun
Country
Hong Kong
Facility Name
Exelixis Clinical Site #39
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Exelixis Clinical Site #51
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Exelixis Clinical Site #88
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Exelixis Clinical Site #81
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Exelixis Clinical Site #84
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Exelixis Clinical Site #121
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Exelixis Clinical Site #97
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Exelixis Clincal Site #129
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Exelixis Clinical Site #41
City
Meldola
State/Province
Forli - Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Exelixis Clinical Site #70
City
Faenza
State/Province
Ravenna
ZIP/Postal Code
48018
Country
Italy
Facility Name
Exelixis Clinical Site #47
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Exelixis Clinical Site #60
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Exelixis Clinical Site #61
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Exelixis Clinical Site #59
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Exelixis Clinical Site #104
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Exelixis Clinical Site #68
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Exelixis Clinical Site #147
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Exelixis Clinical Site #143
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Exelixis Clinical Site #151
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Exelixis Clinical Site #152
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Exelixis Clinical Site #123
City
Aguascalientes
State/Province
Ags
ZIP/Postal Code
20116
Country
Mexico
Facility Name
Exelixis Clinical Site #167
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Exelixis Clinical Site #169
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Exelixis Clinical Site #134
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Exelixis Clinical Site #132
City
Oaxaca de Juarez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Exelixis Clinical Site #160
City
Ciudad de México
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Exelixis Clinical Site #131
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Exelixis Clinical Site #161
City
Querétaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Exelixis Clinical Site #144
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Exelixis Clinical Site #149
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Exelixis Clinical Site #122
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Exelixis Clinical Site #148
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Exelixis Clinical Site #31
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
Facility Name
Exelixis Clinical Site #62
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Exelixis Clinical Site #135
City
Gdańsk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Exelixis Clinical Site #99
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Exelixis Clinical Site #83
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Exelixis Clinical Site #77
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Exelixis Clinical Site #40
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Exelixis Clinical Site #53
City
Santiago De Compostela
State/Province
Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Exelixis Clinical Site #45
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Exelixis Clinical Site #43
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Exelixis Clinical Site #36
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Exelixis Clinical Site #49
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Exelixis Clinical Site #34
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Exelixis Clinical Site #94
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Exelixis Clinical Site #20
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Exelixis Clinical Site #55
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Exelixis Clinical Site #96
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Exelixis Clinical Site #74
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Exelixis Clinical Site #142
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Exelixis Clinical Site #138
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Exelixis Clinical Site #173
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Exelixis Clinical Site #72
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Exelixis Clinical Site #93
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Exelixis Clinical Site #30
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Exelixis Clinical Site #172
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Exelixis Clinical Site #92
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35383907
Citation
Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5. No abstract available.
Results Reference
derived
PubMed Identifier
34550754
Citation
Mar N, Kaakour D, Rezazadeh Kalebasty A. Renal Cell Carcinoma-Lessons in Diversity, Breakthroughs, and Challenges. JCO Oncol Pract. 2022 Mar;18(3):197-199. doi: 10.1200/OP.21.00446. Epub 2021 Sep 22. No abstract available.
Results Reference
derived
PubMed Identifier
33058158
Citation
Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.
Results Reference
derived

Learn more about this trial

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

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