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New triple therapy aims to stall advanced kidney cancer

NCT ID NCT03937219

Disease control Sponsor: Exelixis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding the targeted drug cabozantinib to two immunotherapies (nivolumab and ipilimumab) helps people with advanced kidney cancer live longer without their cancer growing. About 855 participants with intermediate- or poor-risk disease are randomly assigned to receive either the triple combination or the standard two-drug regimen. The study is active but no longer recruiting new participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cabozantinib (a targeted cancer drug) combined with nivolumab and ipilimumab (immunotherapies)
What this could lead to
If successful, this three-drug combination could help people with advanced kidney cancer live longer without their disease getting worse.
What could go wrong
This is an advanced trial, but adding a third drug may increase side effects. The benefit over the current two-drug standard is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

855 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

carcinoma clear cell renal carcinoma neoplasm renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • Exelixis Clincal Site #129

    Ramat Gan, 5265601, Israel

  • Exelixis Clinical Site #1

    Spokane, Washington, 99208, United States

  • Exelixis Clinical Site #10

    Nashville, Tennessee, 37203, United States

  • Exelixis Clinical Site #100

    Santiago, 8420383, Chile

  • Exelixis Clinical Site #101

    Charlotte, North Carolina, 28204, United States

  • Exelixis Clinical Site #102

    Charleston, South Carolina, 29425, United States

  • Exelixis Clinical Site #104

    Perugia, 06132, Italy

  • Exelixis Clinical Site #105

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Exelixis Clinical Site #107

    Portland, Oregon, 97239, United States

  • Exelixis Clinical Site #109

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Exelixis Clinical Site #11

    North Adelaide, South Australia, 5006, Australia

  • Exelixis Clinical Site #110

    Ciudad Autonoma de Buenos Aire, C1426ANZ, Argentina

  • Exelixis Clinical Site #111

    Tuenmen, Hong Kong

  • Exelixis Clinical Site #112

    Brussels, 1000, Belgium

  • Exelixis Clinical Site #113

    Montreal, Quebec, H3T 1E2, Canada

  • Exelixis Clinical Site #114

    Prague, 140 59, Czechia

  • Exelixis Clinical Site #115

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Exelixis Clinical Site #116

    La Jolla, California, 92093, United States

  • Exelixis Clinical Site #117

    Frankfurt am Main, Hesse, 60596, Germany

  • Exelixis Clinical Site #118

    Prague, 150 06, Czechia

  • Exelixis Clinical Site #119

    São Paulo, 01323-001, Brazil

  • Exelixis Clinical Site #12

    Pittsburgh, Pennsylvania, 15232, United States

  • Exelixis Clinical Site #120

    Córdoba, X5004, Argentina

  • Exelixis Clinical Site #121

    Kfar Saba, 4428164, Israel

  • Exelixis Clinical Site #122

    Hamilton, Waikato Region, 3204, New Zealand

  • Exelixis Clinical Site #123

    Aguascalientes, Aguascalientes, 20116, Mexico

  • Exelixis Clinical Site #124

    Dresden, 01307, Germany

  • Exelixis Clinical Site #125

    Rennes, 35042, France

  • Exelixis Clinical Site #126

    Vienna, 1090, Austria

  • Exelixis Clinical Site #127

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Exelixis Clinical Site #128

    Strasbourg, 67000, France

  • Exelixis Clinical Site #13

    Madison, Wisconsin, 53792, United States

  • Exelixis Clinical Site #131

    Querétaro, 76000, Mexico

  • Exelixis Clinical Site #132

    Oaxaca City, Oaxaca, 68000, Mexico

  • Exelixis Clinical Site #134

    Monterrey, Nuevo León, 64710, Mexico

  • Exelixis Clinical Site #135

    Gdansk, 80-219, Poland

  • Exelixis Clinical Site #136

    Shatin, Hong Kong

  • Exelixis Clinical Site #137

    Jena, Thuringia, 077477, Germany

  • Exelixis Clinical Site #138

    Taipei, 10002, Taiwan

  • Exelixis Clinical Site #139

    Münster, North Rhine-Westphalia, 48149, Germany

  • Exelixis Clinical Site #14

    Woolloongabba, Queensland, 4102, Australia

  • Exelixis Clinical Site #140

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Exelixis Clinical Site #141

    São Paulo, 01327-001, Brazil

  • Exelixis Clinical Site #142

    Taichung, 404, Taiwan

  • Exelixis Clinical Site #143

    Seoul, 03722, South Korea

  • Exelixis Clinical Site #144

    Amsterdam, 1105 AZ, Netherlands

  • Exelixis Clinical Site #146

    Hasselt, 3500, Belgium

  • Exelixis Clinical Site #147

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Exelixis Clinical Site #148

    Newtown, Wellington Region, 6021, New Zealand

  • Exelixis Clinical Site #149

    Rotterdam, 3015 GD, Netherlands

  • Exelixis Clinical Site #15

    Detroit, Michigan, 48201, United States

  • Exelixis Clinical Site #150

    Paris, 75015, France

  • Exelixis Clinical Site #151

    Seoul, 05505, South Korea

  • Exelixis Clinical Site #152

    Seoul, 06351, South Korea

  • Exelixis Clinical Site #153

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Exelixis Clinical Site #154

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Exelixis Clinical Site #155

    Curitiba, Paraná, 80530-010, Brazil

  • Exelixis Clinical Site #158

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Exelixis Clinical Site #159

    New York, New York, 10032, United States

  • Exelixis Clinical Site #160

    Mexico City, 03100, Mexico

  • Exelixis Clinical Site #161

    Querétaro, 76090, Mexico

  • Exelixis Clinical Site #162

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Exelixis Clinical Site #163

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Exelixis Clinical Site #164

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Exelixis Clinical Site #166

    Orange, California, 92868-3201, United States

  • Exelixis Clinical Site #167

    León, Guanajuato, 37000, Mexico

  • Exelixis Clinical Site #168

    Barretos, São Paulo, 14784-400, Brazil

  • Exelixis Clinical Site #169

    Zapopan, Jalisco, 45070, Mexico

  • Exelixis Clinical Site #17

    South Brisbane, Queensland, 4101, Australia

  • Exelixis Clinical Site #171

    Münster, North Rhine-Westphalia, 90419, Germany

  • Exelixis Clinical Site #172

    London, W6 8RF, United Kingdom

  • Exelixis Clinical Site #173

    Taoyuan, 333, Taiwan

  • Exelixis Clinical Site #18

    Adelaide, South Australia, 5000, Australia

  • Exelixis Clinical Site #19

    Syracuse, New York, 13210, United States

  • Exelixis Clinical Site #2

    Omaha, Nebraska, 68130, United States

  • Exelixis Clinical Site #20

    Madrid, 28041, Spain

  • Exelixis Clinical Site #22

    Calgary, Alberta, T2N 4N2, Canada

  • Exelixis Clinical Site #23

    Box Hill, Victoria, 3128, Australia

  • Exelixis Clinical Site #24

    Kansas City, Missouri, 64132, United States

  • Exelixis Clinical Site #25

    Toronto, Ontario, M4N 3M5, Canada

  • Exelixis Clinical Site #26

    Subiaco, Western Australia, 6008, Australia

  • Exelixis Clinical Site #27

    North Ryde, New South Wales, 2109, Australia

  • Exelixis Clinical Site #28

    Hong Kong, Hong Kong

  • Exelixis Clinical Site #29

    Boca Raton, Florida, 33486, United States

  • Exelixis Clinical Site #3

    Atlanta, Georgia, 30318, United States

  • Exelixis Clinical Site #30

    London, EC1A 7BE, United Kingdom

  • Exelixis Clinical Site #31

    Biała Podlaska, 21-500, Poland

  • Exelixis Clinical Site #32

    Albury, New South Wales, 2640, Australia

  • Exelixis Clinical Site #33

    Sydney, New South Wales, 2065, Australia

  • Exelixis Clinical Site #34

    Madrid, 28009, Spain

  • Exelixis Clinical Site #35

    Kogarah, New South Wales, 2217, Australia

  • Exelixis Clinical Site #36

    Barcelona, 08036, Spain

  • Exelixis Clinical Site #37

    Villejuif, 94800, France

  • Exelixis Clinical Site #38

    Nashville, Tennessee, 37232, United States

  • Exelixis Clinical Site #39

    Budapest, 1122, Hungary

  • Exelixis Clinical Site #4

    St Louis, Missouri, 63110, United States

  • Exelixis Clinical Site #40

    Singapore, 169610, Singapore

  • Exelixis Clinical Site #41

    Meldola, Forli - Cesena, 47014, Italy

  • Exelixis Clinical Site #42

    Toulouse, 31059, France

  • Exelixis Clinical Site #43

    Barcelona, 08035, Spain

  • Exelixis Clinical Site #44

    Miami, Florida, 33176, United States

  • Exelixis Clinical Site #45

    Pamplona, Navarre, 31008, Spain

  • Exelixis Clinical Site #46

    Ottawa, Ontario, K1H 8L6, Canada

  • Exelixis Clinical Site #47

    Arezzo, 52100, Italy

  • Exelixis Clinical Site #49

    Córdoba, 14004, Spain

  • Exelixis Clinical Site #5

    Myrtle Beach, South Carolina, 29572, United States

  • Exelixis Clinical Site #50

    Helsinki, 00029, Finland

  • Exelixis Clinical Site #51

    Pécs, 7624, Hungary

  • Exelixis Clinical Site #52

    Turku, 20520, Finland

  • Exelixis Clinical Site #53

    Santiago de Compostela, Coruña, 15706, Spain

  • Exelixis Clinical Site #54

    Buenos Aires, C1125ABD, Argentina

  • Exelixis Clinical Site #55

    Madrid, 28050, Spain

  • Exelixis Clinical Site #56

    Tampere, 33520, Finland

  • Exelixis Clinical Site #57

    Seattle, Washington, 98109, United States

  • Exelixis Clinical Site #58A

    Baltimore, Maryland, 21287, United States

  • Exelixis Clinical Site #59

    Pavia, 27100, Italy

  • Exelixis Clinical Site #6

    Burlington, Massachusetts, 01805, United States

  • Exelixis Clinical Site #60

    Modena, 41124, Italy

  • Exelixis Clinical Site #61

    Padova, 35128, Italy

  • Exelixis Clinical Site #62

    Bydgoszcz, 85-796, Poland

  • Exelixis Clinical Site #63

    CABA, C1120AAT, Argentina

  • Exelixis Clinical Site #64

    Fairfax, Virginia, 22031, United States

  • Exelixis Clinical Site #65

    Reims, 51726, France

  • Exelixis Clinical Site #66

    Nice, 06189, France

  • Exelixis Clinical Site #67

    Vandœuvre-lès-Nancy, 54519, France

  • Exelixis Clinical Site #68

    Terni, 05100, Italy

  • Exelixis Clinical Site #69

    Scarborough, Maine, 04074, United States

  • Exelixis Clinical Site #70

    Faenza, Ravenna, 48018, Italy

  • Exelixis Clinical Site #71

    Le Mans, 72000, France

  • Exelixis Clinical Site #72

    Cambridge, CB2 0QQ, United Kingdom

  • Exelixis Clinical Site #73

    San Miguel de Tucumán, Tucumán Province, T4000, Argentina

  • Exelixis Clinical Site #74

    Valencia, 46009, Spain

  • Exelixis Clinical Site #75

    Salzburg, 5020, Austria

  • Exelixis Clinical Site #76

    Linz, Upper Austria, 4020, Austria

  • Exelixis Clinical Site #77

    Singapore, 119074, Singapore

  • Exelixis Clinical Site #78

    Lyon, 69373, France

  • Exelixis Clinical Site #7A

    Boston, Massachusetts, 02215, United States

  • Exelixis Clinical Site #7B

    Boston, Massachusetts, 02114, United States

  • Exelixis Clinical Site #7C

    Boston, Massachusetts, 02215, United States

  • Exelixis Clinical Site #8

    New York, New York, 10065, United States

  • Exelixis Clinical Site #80

    Montpellier, 34295, France

  • Exelixis Clinical Site #81

    Haifa, 3109601, Israel

  • Exelixis Clinical Site #83

    Poznan, 60-693, Poland

  • Exelixis Clinical Site #84

    Jerusalem, 9112001, Israel

  • Exelixis Clinical Site #85

    Temuco, Región de La Araucanía (IX), 4810561, Chile

  • Exelixis Clinical Site #86

    Bordeaux, 33075, France

  • Exelixis Clinical Site #88

    Beersheba, 84101, Israel

  • Exelixis Clinical Site #89

    Králová, 50005, Czechia

  • Exelixis Clinical Site #9

    Ballarat, Victoria, 3350, Australia

  • Exelixis Clinical Site #90

    Strasbourg, 67200, France

  • Exelixis Clinical Site #91

    Santiago, 7500921, Chile

  • Exelixis Clinical Site #92

    Manchester, M20 4BX, United Kingdom

  • Exelixis Clinical Site #93

    Glasgow, G12 0YN, United Kingdom

  • Exelixis Clinical Site #94

    Madrid, 28040, Spain

  • Exelixis Clinical Site #95

    Chicago, Illinois, 60612, United States

  • Exelixis Clinical Site #96

    Oviedo, 33011, Spain

  • Exelixis Clinical Site #97

    Petah Tikva, 49100, Israel

  • Exelixis Clinical Site #98

    Wiener Neustadt, Lower Austria, 2700, Austria

  • Exelixis Clinical Site #99

    Otwock, 05-400, Poland

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