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Can a drug combo outperform standard therapy for a rare kidney cancer?

NCT ID NCT05678673

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a combination of the experimental drug XL092 and the immunotherapy nivolumab can help people with advanced non-clear cell kidney cancer live longer without their disease worsening. Participants have not received prior treatment for their advanced cancer and will be randomly assigned to receive either the new combo or the standard drug sunitinib. The study aims to see if the new approach improves tumor shrinkage and delays cancer progression.

What this could mean

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

Active substance
a combination of an experimental drug called XL092 and the immunotherapy nivolumab (Opdivo)
What this could lead to
If it works, this could offer a more effective first-line treatment option for people with a rare form of advanced kidney cancer.
What could go wrong
This is an early-phase 3 trial, so the combination may not prove better than the current standard. Side effects from the drug combo could be significant.

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

317 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Jun 2028

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 nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed. * Measurable disease according to RECIST v1.1 as determined by the Investigator. * Available archival tumor biopsy material. * Recovery to baseline or ≤ Grade 1 per CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy. * Age 18 years or older on the day of consent. * Karnofsky Performance Status (KPS) ≥ 70%. * Adequate organ and marrow function within 14 days prior to randomization. * Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception. * Female subjects of childbearing potential must not be pregnant at screening. Exclusion Criteria: * Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes of nccRCC. * Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents. * Note: One prior systemic adjuvant therapy, including immune checkpoint inhibitor therapy and excluding sunitinib, is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy. * Radiation therapy for bone metastases 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 (including radiosurgery) or surgically removed and stable for at least 4 weeks before randomization. * Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Subjects who are receiving oral anticoagulants at the time of screening must be transitioned to LMWH prior to randomization. Subjects who require treatment with platelet inhibitors are not eligible. * Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Prior laparoscopic nephrectomy within 4 weeks prior to randomization. Minor surgery (eg, simple excision, tooth extraction) within 10 days before randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization. * Note: Fresh tumor biopsies should be performed at least 7 days before randomization. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 14 days before randomization. * Pregnant or lactating females. * Administration of a live, attenuated vaccine within 30 days before randomization. * Note: If feasible, approved non-live vaccines for SARS-CoV-2 should be administered at least 2 weeks before randomization.

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Conditions

The condition(s) this trial relates to.

nonpapillary renal cell carcinoma

As listed by the trial registrant

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

Non-clear cell renal cell carcinoma

Contacts and locations

Locations

  • Exelixis Clinical Site #1

    Duarte, California, 91010, United States

  • Exelixis Clinical Site #10

    Seoul, 02841, South Korea

  • Exelixis Clinical Site #100

    Elizabeth Vale, South Australia, 5112, Australia

  • Exelixis Clinical Site #101

    São Paulo, 01246-000, Brazil

  • Exelixis Clinical Site #102

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Exelixis Clinical Site #103

    Sofia, 1431, Bulgaria

  • Exelixis Clinical Site #104

    Plovdiv, 4004, Bulgaria

  • Exelixis Clinical Site #105

    Sofia, 1404, Bulgaria

  • Exelixis Clinical Site #106

    Santiago, 7500921, Chile

  • Exelixis Clinical Site #107

    Santiago, 8420383, Chile

  • Exelixis Clinical Site #108

    Santiago, 7520378, Chile

  • Exelixis Clinical Site #109

    Santiago, 8241479, Chile

  • Exelixis Clinical Site #11

    Busan, 49201, South Korea

  • Exelixis Clinical Site #110

    Zagreb, 10000, Croatia

  • Exelixis Clinical Site #111

    Rijeka, 51000, Croatia

  • Exelixis Clinical Site #112

    Olomouc, 77900, Czechia

  • Exelixis Clinical Site #113

    Lyon, 08Rhone69373, France

  • Exelixis Clinical Site #114

    Lille, 59020, France

  • Exelixis Clinical Site #115

    Angers, Maine Et Loire, 49933, France

  • Exelixis Clinical Site #116

    Frankfurt am Main, Hesse, 60590, Germany

  • Exelixis Clinical Site #117

    Hamburg, 22763, Germany

  • Exelixis Clinical Site #118

    Athens, 11528, Greece

  • Exelixis Clinical Site #119

    Athens, 12462, Greece

  • Exelixis Clinical Site #12

    Paris, 75013, France

  • Exelixis Clinical Site #120

    Thessaloniki, 56403, Greece

  • Exelixis Clinical Site #121

    Thessaloniki, 54622, Greece

  • Exelixis Clinical Site #122

    Tripoli, 22131, Greece

  • Exelixis Clinical Site #123

    Athens, 12462, Greece

  • Exelixis Clinical Site #124

    Hong Kong, Hong Kong

  • Exelixis Clinical Site #125

    Hong Kong, Hong Kong

  • Exelixis Clinical Site #126

    Debrecen, 4032, Hungary

  • Exelixis Clinical Site #127

    Budapest, 1122, Hungary

  • Exelixis Clinical Site #128

    Budapest, 1082, Hungary

  • Exelixis Clinical Site #129

    Milan, 20132, Italy

  • Exelixis Clinical Site #13

    Daejeon, 35015, South Korea

  • Exelixis Clinical Site #130

    Rozzano, Milano, 20089, Italy

  • Exelixis Clinical Site #131

    Candiolo, Torino, 10060, Italy

  • Exelixis Clinical Site #132

    Bari, 70124, Italy

  • Exelixis Clinical Site #133

    Poznan, 60-569, Poland

  • Exelixis Clinical Site #134

    Singapore, 168583, Singapore

  • Exelixis Clinical Site #135

    Bratislava, 83310, Slovakia

  • Exelixis Clinical Site #136

    Košice, 04190, Slovakia

  • Exelixis Clinical Site #137

    Banská Bystrica, 97517, Slovakia

  • Exelixis Clinical Site #138

    Barcelona, 8906, Spain

  • Exelixis Clinical Site #139

    Madrid, 28009, Spain

  • Exelixis Clinical Site #14

    Chermside, 4032, Australia

  • Exelixis Clinical Site #140

    Madrid, 28033, Spain

  • Exelixis Clinical Site #141

    Córdoba, 14004, Spain

  • Exelixis Clinical Site #142

    Majadahonda, Madrid, 28220, Spain

  • Exelixis Clinical Site #143

    Palma de Mallorca, Balearic Islands, 7120, Spain

  • Exelixis Clinical Site #144

    Seville, 41009, Spain

  • Exelixis Clinical Site #145

    Málaga, 29011, Spain

  • Exelixis Clinical Site #146

    Phu Wiang, Changwat Khon Kaen, 40002, Thailand

  • Exelixis Clinical Site #147

    Bangkok Noi, Bangkok, 10400, Thailand

  • Exelixis Clinical Site #148

    Istanbul, 34890, Turkey (Türkiye)

  • Exelixis Clinical Site #149

    Ankara, 6010, Turkey (Türkiye)

  • Exelixis Clinical Site #15

    New York, New York, 10065, United States

  • Exelixis Clinical Site #150

    Ankara, 6230, Turkey (Türkiye)

  • Exelixis Clinical Site #151

    Istanbul, 34722, Turkey (Türkiye)

  • Exelixis Clinical Site #152

    Ankara, 6800, Turkey (Türkiye)

  • Exelixis Clinical Site #153

    Adana, 1230, Turkey (Türkiye)

  • Exelixis Clinical Site #154

    Izmir, 35575, Turkey (Türkiye)

  • Exelixis Clinical Site #155

    Ankara, 6590, Turkey (Türkiye)

  • Exelixis Clinical Site #156

    Ankara, 06520, Turkey (Türkiye)

  • Exelixis Clinical Site #157

    Adana, 1140, Turkey (Türkiye)

  • Exelixis Clinical Site #158

    Sheffield, South Yorkshire, S10 2SJ, United Kingdom

  • Exelixis Clinical Site #159

    London, SE1 9RT, United Kingdom

  • Exelixis Clinical Site #16

    Goyang-si, 10408, South Korea

  • Exelixis Clinical Site #160

    London, EC1M 6BQ, United Kingdom

  • Exelixis Clinical Site #161

    Buffalo, New York, 14263, United States

  • Exelixis Clinical Site #162

    San Francisco, California, 94115, United States

  • Exelixis Clinical Site #163

    Aurora, Colorado, 80045, United States

  • Exelixis Clinical Site #164

    Newport Beach, California, 92663, United States

  • Exelixis Clinical Site #17

    Verona, 37134, Italy

  • Exelixis Clinical Site #18

    Seville, 41013, Spain

  • Exelixis Clinical Site #19

    Meldola, 47014, Italy

  • Exelixis Clinical Site #20

    Seoul, 06591, South Korea

  • Exelixis Clinical Site #21

    Seongnam-si, 13496, South Korea

  • Exelixis Clinical Site #22

    Daegu, 42601, South Korea

  • Exelixis Clinical Site #23

    Rzeszów, 35-021, Poland

  • Exelixis Clinical Site #24

    Kuala Lumpur, 59100, Malaysia

  • Exelixis Clinical Site #25

    Gyeonggi-do, 16247, South Korea

  • Exelixis Clinical Site #26

    Brescia, 25123, Italy

  • Exelixis Clinical Site #27

    Prague, 140 59, Czechia

  • Exelixis Clinical Site #28

    Rennes, 35042, France

  • Exelixis Clinical Site #29

    South Brisbane, 4101, Australia

  • Exelixis Clinical Site #3

    Madrid, 28034, Spain

  • Exelixis Clinical Site #30

    Naples, 80131, Italy

  • Exelixis Clinical Site #31

    Dallas, Texas, 75246, United States

  • Exelixis Clinical Site #32

    Busan, 49267, South Korea

  • Exelixis Clinical Site #33

    Otwock, 05-400, Poland

  • Exelixis Clinical Site #34

    Madrid, 28041, Spain

  • Exelixis Clinical Site #35

    CABA, C1419GEP, Argentina

  • Exelixis Clinical Site #36

    Marseille, 13385, France

  • Exelixis Clinical Site #37

    Pavia, 27100, Italy

  • Exelixis Clinical Site #38

    Le Mans, 72000, France

  • Exelixis Clinical Site #39

    Itajaí, 88301-220, Brazil

  • Exelixis Clinical Site #4

    Seoul, 03722, South Korea

  • Exelixis Clinical Site #40

    Créteil, 94010, France

  • Exelixis Clinical Site #41

    Strasbourg, 67200, France

  • Exelixis Clinical Site #42

    Cleveland, Ohio, 44106, United States

  • Exelixis Clinical Site #43

    São Paulo, 17210-120, Brazil

  • Exelixis Clinical Site #44

    Buenos Aires, B7600FZO, Argentina

  • Exelixis Clinical Site #45

    Bydgoszcz, 85-796, Poland

  • Exelixis Clinical Site #46

    Putrajaya, 62250, Malaysia

  • Exelixis Clinical Site #47

    Seoul, 05505, South Korea

  • Exelixis Clinical Site #48

    Reggio Emilia, 42123, Italy

  • Exelixis Clinical Site #49

    Gdansk, 80-219, Poland

  • Exelixis Clinical Site #5

    Seongnam-si, 13620, South Korea

  • Exelixis Clinical Site #50

    São José do Rio Preto, 15090-000, Brazil

  • Exelixis Clinical Site #51

    Santa Fe, 2000, Argentina

  • Exelixis Clinical Site #52

    Barcelona, 08041, Spain

  • Exelixis Clinical Site #53

    Providencia, 7520378, Chile

  • Exelixis Clinical Site #54

    Kuala Lumpur, 50586, Malaysia

  • Exelixis Clinical Site #55

    Jacksonville, Florida, 32209, United States

  • Exelixis Clinical Site #56

    Barcelona, 08035, Spain

  • Exelixis Clinical Site #57

    Oviedo, 33011, Spain

  • Exelixis Clinical Site #58

    New York, New York, 10029, United States

  • Exelixis Clinical Site #59

    Reims, 51726, France

  • Exelixis Clinical Site #6

    Seoul, 06351, South Korea

  • Exelixis Clinical Site #60

    Roma, 00168, Italy

  • Exelixis Clinical Site #61

    Brno, 602 00, Czechia

  • Exelixis Clinical Site #62

    Girona, 17007, Spain

  • Exelixis Clinical Site #63

    Pisa, 56126, Italy

  • Exelixis Clinical Site #64

    Eindhoven, 631BM, Netherlands

  • Exelixis Clinical Site #65

    Suresnes, 92150, France

  • Exelixis Clinical Site #66

    Clermont-Ferrand, 63011, France

  • Exelixis Clinical Site #67

    Paris, 75475, France

  • Exelixis Clinical Site #68

    Barretos, 14784 400, Brazil

  • Exelixis Clinical Site #69

    Passo Fundo, 99010-090, Brazil

  • Exelixis Clinical Site #7

    Arezzo, 52100, Italy

  • Exelixis Clinical Site #70

    Porto Alegre, 90110-270, Brazil

  • Exelixis Clinical Site #71

    Helsinki, 00290, Finland

  • Exelixis Clinical Site #72

    San Giovanni Rotondo, 71013, Italy

  • Exelixis Clinical Site #73

    Valencia, 46009, Spain

  • Exelixis Clinical Site #74

    Caen, 14076, France

  • Exelixis Clinical Site #75

    Santander, 39008, Spain

  • Exelixis Clinical Site #76

    Pierre-Bénite, 69310, France

  • Exelixis Clinical Site #77

    Poznan, 02-781, Poland

  • Exelixis Clinical Site #78

    Porto Alegre, 91350-200, Brazil

  • Exelixis Clinical Site #79

    Eisleben Lutherstadt, 06295, Germany

  • Exelixis Clinical Site #8

    Madrid, 28046, Spain

  • Exelixis Clinical Site #80

    Poznan, 60-693, Poland

  • Exelixis Clinical Site #81

    São Paulo, 01323-001, Brazil

  • Exelixis Clinical Site #82

    Chiang Mai, 50200, Thailand

  • Exelixis Clinical Site #83

    Bangkok, 10400, Thailand

  • Exelixis Clinical Site #84

    Bangkok, 10330, Thailand

  • Exelixis Clinical Site #85

    São Paulo, 01323-903, Brazil

  • Exelixis Clinical Site #86

    Prague, 150 06, Czechia

  • Exelixis Clinical Site #87

    Santo André, 09060-870, Brazil

  • Exelixis Clinical Site #88

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Exelixis Clinical Site #89

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Exelixis Clinical Site #9

    Barcelona, 08036, Spain

  • Exelixis Clinical Site #90

    Córdoba, X5004BAL, Argentina

  • Exelixis Clinical Site #91

    Box Hill, Victoria, 3128, Australia

  • Exelixis Clinical Site #92

    Sydney, New South Wales, 2145, Australia

  • Exelixis Clinical Site #93

    Waratah, New South Wales, 2298, Australia

  • Exelixis Clinical Site #94

    Albury, New South Wales, 2640, Australia

  • Exelixis Clinical Site #95

    Macquarie, New South Wales, 2109, Australia

  • Exelixis Clinical Site #96

    St Albans, Victoria, 3021, Australia

  • Exelixis Clinical Site #97

    Camperdown, New South Wales, 3021, Australia

  • Exelixis Clinical Site #98

    Liverpool, New South Wales, 2170, Australia

  • Exelixis Clinical Site #99

    Douglas, Queensland, 4814, Australia

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Other studies related to the condition(s) this trial covers.