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ACTIVE NOT RECRUITING

NCT05678673

PHASE3

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Sponsor: Exelixis

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.

Official title: A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

317

Start Date

2023-01-01

Completion Date

2028-06

Last Updated

2025-07-14

Healthy Volunteers

Conditions

Non-Clear Cell Renal Cell Carcinoma

Interventions

DRUG

XL092

Specified doses on specified days

DRUG

Nivolumab

Specified doses on specified days

DRUG

Sunitinib Malate

Specified doses on specified days

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.

Locations (163)

Exelixis Clinical Site #1

Duarte, California, United States

Exelixis Clinical Site #164

Newport Beach, California, United States

Exelixis Clinical Site #162

San Francisco, California, United States

Exelixis Clinical Site #163

Aurora, Colorado, United States

Exelixis Clinical Site #55

Jacksonville, Florida, United States

Exelixis Clinical Site #161

Buffalo, New York, United States

Exelixis Clinical Site #58

New York, New York, United States

Exelixis Clinical Site #15

New York, New York, United States

Exelixis Clinical Site #42

Cleveland, Ohio, United States

Exelixis Clinical Site #31

Dallas, Texas, United States

Exelixis Clinical Site #88

Pilar, Buenos Aires, Argentina

Exelixis Clinical Site #89

Viedma, Río Negro Province, Argentina

Exelixis Clinical Site #44

Buenos Aires, Argentina

Exelixis Clinical Site #35

CABA, Argentina

Exelixis Clinical Site #90

Córdoba, Argentina

Exelixis Clinical Site #51

Santa Fe, Argentina

Exelixis Clinical Site #94

Albury, New South Wales, Australia

Exelixis Clinical Site #97

Camperdown, New South Wales, Australia

Exelixis Clinical Site #98

Liverpool, New South Wales, Australia

Exelixis Clinical Site #95

Macquarie, New South Wales, Australia

Exelixis Clinical Site #92

Sydney, New South Wales, Australia

Exelixis Clinical Site #93

Waratah, New South Wales, Australia

Exelixis Clinical Site #99

Douglas, Queensland, Australia

Exelixis Clinical Site #100

Elizabeth Vale, South Australia, Australia

Exelixis Clinical Site #91

Box Hill, Victoria, Australia

Exelixis Clinical Site #96

St Albans, Victoria, Australia

Exelixis Clinical Site #14

Chermside, Australia

Exelixis Clinical Site #29

South Brisbane, Australia

Exelixis Clinical Site #102

Porto Alegre, Rio Grande do Sul, Brazil

Exelixis Clinical Site #68

Barretos, Brazil

Exelixis Clinical Site #39

Itajaí, Brazil

Exelixis Clinical Site #69

Passo Fundo, Brazil

Exelixis Clinical Site #70

Porto Alegre, Brazil

Exelixis Clinical Site #78

Porto Alegre, Brazil

Exelixis Clinical Site #87

Santo André, Brazil

Exelixis Clinical Site #50

São José do Rio Preto, Brazil

Exelixis Clinical Site #101

São Paulo, Brazil

Exelixis Clinical Site #81

São Paulo, Brazil

Exelixis Clinical Site #85

São Paulo, Brazil

Exelixis Clinical Site #43

São Paulo, Brazil

Exelixis Clinical Site #104

Plovdiv, Bulgaria

Exelixis Clinical Site #105

Sofia, Bulgaria

Exelixis Clinical Site #103

Sofia, Bulgaria

Exelixis Clinical Site #53

Providencia, Chile

Exelixis Clinical Site #106

Santiago, Chile

Exelixis Clinical Site #108

Santiago, Chile

Exelixis Clinical Site #109

Santiago, Chile

Exelixis Clinical Site #107

Santiago, Chile

Exelixis Clinical Site #111

Rijeka, Croatia

Exelixis Clinical Site #110

Zagreb, Croatia

Exelixis Clinical Site #61

Brno, Czechia

Exelixis Clinical Site #112

Olomouc, Czechia

Exelixis Clinical Site #27

Prague, Czechia

Exelixis Clinical Site #86

Prague, Czechia

Exelixis Clinical Site #71

Helsinki, Finland

Exelixis Clinical Site #115

Angers, Maine Et Loire, France

Exelixis Clinical Site #74

Caen, France

Exelixis Clinical Site #66

Clermont-Ferrand, France

Exelixis Clinical Site #40

Créteil, France

Exelixis Clinical Site #38

Le Mans, France

Exelixis Clinical Site #114

Lille, France

Exelixis Clinical Site #113

Lyon, France

Exelixis Clinical Site #36

Marseille, France

Exelixis Clinical Site #12

Paris, France

Exelixis Clinical Site #67

Paris, France

Exelixis Clinical Site #76

Pierre-Bénite, France

Exelixis Clinical Site #59

Reims, France

Exelixis Clinical Site #28

Rennes, France

Exelixis Clinical Site #41

Strasbourg, France

Exelixis Clinical Site #65

Suresnes, France

Exelixis Clinical Site #116

Frankfurt am Main, Hesse, Germany

Exelixis Clinical Site #79

Eisleben Lutherstadt, Germany

Exelixis Clinical Site #117

Hamburg, Germany

Exelixis Clinical Site #118

Athens, Greece

Exelixis Clinical Site #119

Athens, Greece

Exelixis Clinical Site #123

Athens, Greece

Exelixis Clinical Site #121

Thessaloniki, Greece

Exelixis Clinical Site #120

Thessaloniki, Greece

Exelixis Clinical Site #122

Tripoli, Greece

Exelixis Clinical Site #124

Hong Kong, Hong Kong

Exelixis Clinical Site #125

Hong Kong, Hong Kong

Exelixis Clinical Site #128

Budapest, Hungary

Exelixis Clinical Site #127

Budapest, Hungary

Exelixis Clinical Site #126

Debrecen, Hungary

Exelixis Clinical Site #130

Rozzano, Milano, Italy

Exelixis Clinical Site #131

Candiolo, Torino, Italy

Exelixis Clinical Site #7

Arezzo, Italy

Exelixis Clinical Site #132

Bari, Italy

Exelixis Clinical Site #26

Brescia, Italy

Exelixis Clinical Site #19

Meldola, Italy

Exelixis Clinical Site #129

Milan, Italy

Exelixis Clinical Site #30

Naples, Italy

Exelixis Clinical Site #37

Pavia, Italy

Exelixis Clinical Site #63

Pisa, Italy

Exelixis Clinical Site #48

Reggio Emilia, Italy

Exelixis Clinical Site #60

Roma, Italy

Exelixis Clinical Site #72

San Giovanni Rotondo, Italy

Exelixis Clinical Site #17

Verona, Italy

Exelixis Clinical Site #54

Kuala Lumpur, Malaysia

Exelixis Clinical Site #24

Kuala Lumpur, Malaysia

Exelixis Clinical Site #46

Putrajaya, Malaysia

Exelixis Clinical Site #64

Eindhoven, Netherlands

Exelixis Clinical Site #45

Bydgoszcz, Poland

Exelixis Clinical Site #49

Gdansk, Poland

Exelixis Clinical Site #33

Otwock, Poland

Exelixis Clinical Site #77

Poznan, Poland

Exelixis Clinical Site #133

Poznan, Poland

Exelixis Clinical Site #80

Poznan, Poland

Exelixis Clinical Site #23

Rzeszów, Poland

Exelixis Clinical Site #134

Singapore, Singapore

Exelixis Clinical Site #137

Banská Bystrica, Slovakia

Exelixis Clinical Site #135

Bratislava, Slovakia

Exelixis Clinical Site #136

Košice, Slovakia

Exelixis Clinical Site #11

Busan, South Korea

Exelixis Clinical Site #32

Busan, South Korea

Exelixis Clinical Site #22

Daegu, South Korea

Exelixis Clinical Site #13

Daejeon, South Korea

Exelixis Clinical Site #16

Goyang-si, South Korea

Exelixis Clinical Site #25

Gyeonggi-do, South Korea

Exelixis Clinical Site #21

Seongnam-si, South Korea

Exelixis Clinical Site #5

Seongnam-si, South Korea

Exelixis Clinical Site #10

Seoul, South Korea

Exelixis Clinical Site #4

Seoul, South Korea

Exelixis Clinical Site #47

Seoul, South Korea

Exelixis Clinical Site #6

Seoul, South Korea

Exelixis Clinical Site #20

Seoul, South Korea

Exelixis Clinical Site #143

Palma de Mallorca, Balearic Islands, Spain

Exelixis Clinical Site #142

Majadahonda, Madrid, Spain

Exelixis Clinical Site #56

Barcelona, Spain

Exelixis Clinical Site #9

Barcelona, Spain

Exelixis Clinical Site #52

Barcelona, Spain

Exelixis Clinical Site #138

Barcelona, Spain

Exelixis Clinical Site #141

Córdoba, Spain

Exelixis Clinical Site #62

Girona, Spain

Exelixis Clinical Site #139

Madrid, Spain

Exelixis Clinical Site #140

Madrid, Spain

Exelixis Clinical Site #3

Madrid, Spain

Exelixis Clinical Site #34

Madrid, Spain

Exelixis Clinical Site #8

Madrid, Spain

Exelixis Clinical Site #145

Málaga, Spain

Exelixis Clinical Site #57

Oviedo, Spain

Exelixis Clinical Site #75

Santander, Spain

Exelixis Clinical Site #144

Seville, Spain

Exelixis Clinical Site #18

Seville, Spain

Exelixis Clinical Site #73

Valencia, Spain

Exelixis Clinical Site #147

Bangkok Noi, Bangkok, Thailand

Exelixis Clinical Site #146

Phu Wiang, Changwat Khon Kaen, Thailand

Exelixis Clinical Site #84

Bangkok, Thailand

Exelixis Clinical Site #83

Bangkok, Thailand

Exelixis Clinical Site #82

Chiang Mai, Thailand

Exelixis Clinical Site #157

Adana, Turkey (Türkiye)

Exelixis Clinical Site #153

Adana, Turkey (Türkiye)

Exelixis Clinical Site #156

Ankara, Turkey (Türkiye)

Exelixis Clinical Site #149

Ankara, Turkey (Türkiye)

Exelixis Clinical Site #150

Ankara, Turkey (Türkiye)

Exelixis Clinical Site #155

Ankara, Turkey (Türkiye)

Exelixis Clinical Site #152

Ankara, Turkey (Türkiye)

Exelixis Clinical Site #151

Istanbul, Turkey (Türkiye)

Exelixis Clinical Site #148

Istanbul, Turkey (Türkiye)

Exelixis Clinical Site #154

Izmir, Turkey (Türkiye)

Exelixis Clinical Site #158

Sheffield, South Yorkshire, United Kingdom

Exelixis Clinical Site #160

London, United Kingdom

Exelixis Clinical Site #159

London, United Kingdom

Clinical Research Directory

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (163)