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ACTIVE NOT RECRUITING

NCT03937219

PHASE3

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

Sponsor: Exelixis

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

855

Start Date

2019-06-25

Completion Date

2027-01-31

Last Updated

2025-09-10

Healthy Volunteers

Conditions

Renal Cell Carcinoma

Interventions

DRUG

Cabozantinib

Specified dose on specified days.

BIOLOGICAL

Nivolumab

Specified dose on specified days.

BIOLOGICAL

Ipilimumab

Specified dose on specified days.

DRUG

Cabozantinib-matched placebo

Specified dose on specified days.

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.

Locations (159)

Exelixis Clinical Site #116

La Jolla, California, United States

Exelixis Clinical Site #166

Orange, California, United States

Exelixis Clinical Site #29

Boca Raton, Florida, United States

Exelixis Clinical Site #44

Miami, Florida, United States

Exelixis Clinical Site #3

Atlanta, Georgia, United States

Exelixis Clinical Site #95

Chicago, Illinois, United States

Exelixis Clinical Site #69

Scarborough, Maine, United States

Exelixis Clinical Site #58A

Baltimore, Maryland, United States

Exelixis Clinical Site #7B

Boston, Massachusetts, United States

Exelixis Clinical Site #7A

Boston, Massachusetts, United States

Exelixis Clinical Site #7C

Boston, Massachusetts, United States

Exelixis Clinical Site #6

Burlington, Massachusetts, United States

Exelixis Clinical Site #15

Detroit, Michigan, United States

Exelixis Clinical Site #24

Kansas City, Missouri, United States

Exelixis Clinical Site #4

St Louis, Missouri, United States

Exelixis Clinical Site #2

Omaha, Nebraska, United States

Exelixis Clinical Site #159

New York, New York, United States

Exelixis Clinical Site #8

New York, New York, United States

Exelixis Clinical Site #19

Syracuse, New York, United States

Exelixis Clinical Site #101

Charlotte, North Carolina, United States

Exelixis Clinical Site #107

Portland, Oregon, United States

Exelixis Clinical Site #12

Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #102

Charleston, South Carolina, United States

Exelixis Clinical Site #5

Myrtle Beach, South Carolina, United States

Exelixis Clinical Site #10

Nashville, Tennessee, United States

Exelixis Clinical Site #38

Nashville, Tennessee, United States

Exelixis Clinical Site #64

Fairfax, Virginia, United States

Exelixis Clinical Site #57

Seattle, Washington, United States

Exelixis Clinical Site #1

Spokane, Washington, United States

Exelixis Clinical Site #13

Madison, Wisconsin, United States

Exelixis Clinical Site #153

Pilar, Buenos Aires, Argentina

Exelixis Clinical Site #109

Rosario, Santa Fe Province, Argentina

Exelixis Clinical Site #73

San Miguel de Tucumán, Tucumán Province, Argentina

Exelixis Clinical Site #54

Buenos Aires, Argentina

Exelixis Clinical Site #63

CABA, Argentina

Exelixis Clinical Site #110

Ciudad Autonoma de Buenos Aire, Argentina

Exelixis Clinical Site #120

Córdoba, Argentina

Exelixis Clinical Site #32

Albury, New South Wales, Australia

Exelixis Clinical Site #35

Kogarah, New South Wales, Australia

Exelixis Clinical Site #27

North Ryde, New South Wales, Australia

Exelixis Clinical Site #33

Sydney, New South Wales, Australia

Exelixis Clinical Site #17

South Brisbane, Queensland, Australia

Exelixis Clinical Site #14

Woolloongabba, Queensland, Australia

Exelixis Clinical Site #18

Adelaide, South Australia, Australia

Exelixis Clinical Site #11

North Adelaide, South Australia, Australia

Exelixis Clinical Site #9

Ballarat, Victoria, Australia

Exelixis Clinical Site #23

Box Hill, Victoria, Australia

Exelixis Clinical Site #26

Subiaco, Western Australia, Australia

Exelixis Clinical Site #98

Wiener Neustadt, Lower Austria, Austria

Exelixis Clinical Site #76

Linz, Upper Austria, Austria

Exelixis Clinical Site #75

Salzburg, Austria

Exelixis Clinical Site #126

Vienna, Austria

Exelixis Clinical Site #112

Brussels, Belgium

Exelixis Clinical Site #146

Hasselt, Belgium

Exelixis Clinical Site #154

Belo Horizonte, Minas Gerais, Brazil

Exelixis Clinical Site #155

Curitiba, Paraná, Brazil

Exelixis Clinical Site #158

Porto Alegre, Rio Grande do Sul, Brazil

Exelixis Clinical Site #140

Porto Alegre, Rio Grande do Sul, Brazil

Exelixis Clinical Site #163

Porto Alegre, Rio Grande do Sul, Brazil

Exelixis Clinical Site #168

Barretos, São Paulo, Brazil

Exelixis Clinical Site #162

São José do Rio Preto, São Paulo, Brazil

Exelixis Clinical Site #119

São Paulo, Brazil

Exelixis Clinical Site #141

São Paulo, Brazil

Exelixis Clinical Site #22

Calgary, Alberta, Canada

Exelixis Clinical Site #105

Winnipeg, Manitoba, Canada

Exelixis Clinical Site #46

Ottawa, Ontario, Canada

Exelixis Clinical Site #25

Toronto, Ontario, Canada

Exelixis Clinical Site #113

Montreal, Quebec, Canada

Exelixis Clinical Site #85

Temuco, Región de La Araucanía (IX), Chile

Exelixis Clinical Site #91

Santiago, Chile

Exelixis Clinical Site #100

Santiago, Chile

Exelixis Clinical Site #89

Králová, Czechia

Exelixis Clinical Site #114

Prague, Czechia

Exelixis Clinical Site #118

Prague, Czechia

Exelixis Clinical Site #50

Helsinki, Finland

Exelixis Clinical Site #56

Tampere, Finland

Exelixis Clinical Site #52

Turku, Finland

Exelixis Clinical Site #86

Bordeaux, France

Exelixis Clinical Site #71

Le Mans, France

Exelixis Clinical Site #78

Lyon, France

Exelixis Clinical Site #80

Montpellier, France

Exelixis Clinical Site #66

Nice, France

Exelixis Clinical Site #150

Paris, France

Exelixis Clinical Site #65

Reims, France

Exelixis Clinical Site #125

Rennes, France

Exelixis Clinical Site #128

Strasbourg, France

Exelixis Clinical Site #90

Strasbourg, France

Exelixis Clinical Site #42

Toulouse, France

Exelixis Clinical Site #67

Vandœuvre-lès-Nancy, France

Exelixis Clinical Site #37

Villejuif, France

Exelixis Clinical Site #127

Heidelberg, Baden-Wurttemberg, Germany

Exelixis Clinical Site #115

Tübingen, Baden-Wurttemberg, Germany

Exelixis Clinical Site #117

Frankfurt am Main, Hesse, Germany

Exelixis Clinical Site #139

Münster, North Rhine-Westphalia, Germany

Exelixis Clinical Site #171

Münster, North Rhine-Westphalia, Germany

Exelixis Clinical Site #164

Mainz, Rhineland-Palatinate, Germany

Exelixis Clinical Site #137

Jena, Thuringia, Germany

Exelixis Clinical Site #124

Dresden, Germany

Exelixis Clinical Site #28

Hong Kong, Hong Kong

Exelixis Clinical Site #136

Shatin, Hong Kong

Exelixis Clinical Site #111

Tuenmen, Hong Kong

Exelixis Clinical Site #39

Budapest, Hungary

Exelixis Clinical Site #51

Pécs, Hungary

Exelixis Clinical Site #88

Beersheba, Israel

Exelixis Clinical Site #81

Haifa, Israel

Exelixis Clinical Site #84

Jerusalem, Israel

Exelixis Clinical Site #121

Kfar Saba, Israel

Exelixis Clinical Site #97

Petah Tikva, Israel

Exelixis Clincal Site #129

Ramat Gan, Israel

Exelixis Clinical Site #41

Meldola, Forli - Cesena, Italy

Exelixis Clinical Site #70

Faenza, Ravenna, Italy

Exelixis Clinical Site #47

Arezzo, Italy

Exelixis Clinical Site #60

Modena, Italy

Exelixis Clinical Site #61

Padova, Italy

Exelixis Clinical Site #59

Pavia, Italy

Exelixis Clinical Site #104

Perugia, Italy

Exelixis Clinical Site #68

Terni, Italy

Exelixis Clinical Site #123

Aguascalientes, Aguascalientes, Mexico

Exelixis Clinical Site #167

León, Guanajuato, Mexico

Exelixis Clinical Site #169

Zapopan, Jalisco, Mexico

Exelixis Clinical Site #134

Monterrey, Nuevo León, Mexico

Exelixis Clinical Site #132

Oaxaca City, Oaxaca, Mexico

Exelixis Clinical Site #160

Mexico City, Mexico

Exelixis Clinical Site #131

Querétaro, Mexico

Exelixis Clinical Site #161

Querétaro, Mexico

Exelixis Clinical Site #144

Amsterdam, Netherlands

Exelixis Clinical Site #149

Rotterdam, Netherlands

Exelixis Clinical Site #122

Hamilton, Waikato Region, New Zealand

Exelixis Clinical Site #148

Newtown, Wellington Region, New Zealand

Exelixis Clinical Site #31

Biała Podlaska, Poland

Exelixis Clinical Site #62

Bydgoszcz, Poland

Exelixis Clinical Site #135

Gdansk, Poland

Exelixis Clinical Site #99

Otwock, Poland

Exelixis Clinical Site #83

Poznan, Poland

Exelixis Clinical Site #77

Singapore, Singapore

Exelixis Clinical Site #40

Singapore, Singapore

Exelixis Clinical Site #147

Seongnam-si, Gyeonggi-do, South Korea

Exelixis Clinical Site #143

Seoul, South Korea

Exelixis Clinical Site #151

Seoul, South Korea

Exelixis Clinical Site #152

Seoul, South Korea

Exelixis Clinical Site #53

Santiago de Compostela, Coruña, Spain

Exelixis Clinical Site #45

Pamplona, Navarre, Spain

Exelixis Clinical Site #43

Barcelona, Spain

Exelixis Clinical Site #36

Barcelona, Spain

Exelixis Clinical Site #49

Córdoba, Spain

Exelixis Clinical Site #34

Madrid, Spain

Exelixis Clinical Site #94

Madrid, Spain

Exelixis Clinical Site #20

Madrid, Spain

Exelixis Clinical Site #55

Madrid, Spain

Exelixis Clinical Site #96

Oviedo, Spain

Exelixis Clinical Site #74

Valencia, Spain

Exelixis Clinical Site #142

Taichung, Taiwan

Exelixis Clinical Site #138

Taipei, Taiwan

Exelixis Clinical Site #173

Taoyuan District, Taiwan

Exelixis Clinical Site #72

Cambridge, United Kingdom

Exelixis Clinical Site #93

Glasgow, United Kingdom

Exelixis Clinical Site #30

London, United Kingdom

Exelixis Clinical Site #172

London, United Kingdom

Exelixis Clinical Site #92

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (159)