Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (STELLAR-304)
July 28, 2026 updated by: Exelixis
A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
317
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, B7600FZO
- Exelixis Clinical Site #44
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CABA, Argentina, C1419GEP
- Exelixis Clinical Site #35
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Córdoba, Argentina, X5004BAL
- Exelixis Clinical Site #90
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Santa Fe, Argentina, 2000
- Exelixis Clinical Site #51
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Buenos Aires
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Pilar, Buenos Aires, Argentina, B1629ODT
- Exelixis Clinical Site #88
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Río Negro Province
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Viedma, Río Negro Province, Argentina, R8500ACE
- Exelixis Clinical Site #89
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Chermside, Australia, 4032
- Exelixis Clinical Site #14
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South Brisbane, Australia, 4101
- Exelixis Clinical Site #29
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New South Wales
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Albury, New South Wales, Australia, 2640
- Exelixis Clinical Site #94
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Camperdown, New South Wales, Australia, 3021
- Exelixis Clinical Site #97
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Liverpool, New South Wales, Australia, 2170
- Exelixis Clinical Site #98
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Macquarie, New South Wales, Australia, 2109
- Exelixis Clinical Site #95
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Sydney, New South Wales, Australia, 2145
- Exelixis Clinical Site #92
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Waratah, New South Wales, Australia, 2298
- Exelixis Clinical Site #93
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Queensland
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Douglas, Queensland, Australia, 4814
- Exelixis Clinical Site #99
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
- Exelixis Clinical Site #100
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Victoria
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Box Hill, Victoria, Australia, 3128
- Exelixis Clinical Site #91
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St Albans, Victoria, Australia, 3021
- Exelixis Clinical Site #96
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Barretos, Brazil, 14784 400
- Exelixis Clinical Site #68
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Itajaí, Brazil, 88301-220
- Exelixis Clinical Site #39
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Passo Fundo, Brazil, 99010-090
- Exelixis Clinical Site #69
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Porto Alegre, Brazil, 90110-270
- Exelixis Clinical Site #70
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Porto Alegre, Brazil, 91350-200
- Exelixis Clinical Site #78
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Santo André, Brazil, 09060-870
- Exelixis Clinical Site #87
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São José do Rio Preto, Brazil, 15090-000
- Exelixis Clinical Site #50
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São Paulo, Brazil, 01246-000
- Exelixis Clinical Site #101
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São Paulo, Brazil, 01323-001
- Exelixis Clinical Site #81
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São Paulo, Brazil, 01323-903
- Exelixis Clinical Site #85
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São Paulo, Brazil, 17210-120
- Exelixis Clinical Site #43
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Exelixis Clinical Site #102
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Plovdiv, Bulgaria, 4004
- Exelixis Clinical Site #104
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Sofia, Bulgaria, 1404
- Exelixis Clinical Site #105
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Sofia, Bulgaria, 1431
- Exelixis Clinical Site #103
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Providencia, Chile, 7520378
- Exelixis Clinical Site #53
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Santiago, Chile, 7500921
- Exelixis Clinical Site #106
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Santiago, Chile, 7520378
- Exelixis Clinical Site #108
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Santiago, Chile, 8241479
- Exelixis Clinical Site #109
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Santiago, Chile, 8420383
- Exelixis Clinical Site #107
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Rijeka, Croatia, 51000
- Exelixis Clinical Site #111
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Zagreb, Croatia, 10000
- Exelixis Clinical Site #110
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Brno, Czechia, 602 00
- Exelixis Clinical Site #61
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Olomouc, Czechia, 77900
- Exelixis Clinical Site #112
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Prague, Czechia, 140 59
- Exelixis Clinical Site #27
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Prague, Czechia, 150 06
- Exelixis Clinical Site #86
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Helsinki, Finland, 00290
- Exelixis Clinical Site #71
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Caen, France, 14076
- Exelixis Clinical Site #74
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Clermont-Ferrand, France, 63011
- Exelixis Clinical Site #66
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Créteil, France, 94010
- Exelixis Clinical Site #40
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Le Mans, France, 72000
- Exelixis Clinical Site #38
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Lille, France, 59020
- Exelixis Clinical Site #114
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Lyon, France, 08Rhone69373
- Exelixis Clinical Site #113
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Marseille, France, 13385
- Exelixis Clinical Site #36
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Paris, France, 75013
- Exelixis Clinical Site #12
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Paris, France, 75475
- Exelixis Clinical Site #67
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Pierre-Bénite, France, 69310
- Exelixis Clinical Site #76
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Reims, France, 51726
- Exelixis Clinical Site #59
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Rennes, France, 35042
- Exelixis Clinical Site #28
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Strasbourg, France, 67200
- Exelixis Clinical Site #41
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Suresnes, France, 92150
- Exelixis Clinical Site #65
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Maine Et Loire
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Angers, Maine Et Loire, France, 49933
- Exelixis Clinical Site #115
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Eisleben Lutherstadt, Germany, 06295
- Exelixis Clinical Site #79
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Hamburg, Germany, 22763
- Exelixis Clinical Site #117
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Hesse
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Frankfurt am Main, Hesse, Germany, 60590
- Exelixis Clinical Site #116
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Athens, Greece, 11528
- Exelixis Clinical Site #118
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Athens, Greece, 12462
- Exelixis Clinical Site #119
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Athens, Greece, 12462
- Exelixis Clinical Site #123
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Thessaloniki, Greece, 54622
- Exelixis Clinical Site #121
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Thessaloniki, Greece, 56403
- Exelixis Clinical Site #120
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Tripoli, Greece, 22131
- Exelixis Clinical Site #122
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Hong Kong, Hong Kong
- Exelixis Clinical Site #124
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Hong Kong, Hong Kong
- Exelixis Clinical Site #125
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Budapest, Hungary, 1082
- Exelixis Clinical Site #128
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Budapest, Hungary, 1122
- Exelixis Clinical Site #127
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Debrecen, Hungary, 4032
- Exelixis Clinical Site #126
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Arezzo, Italy, 52100
- Exelixis Clinical Site #7
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Bari, Italy, 70124
- Exelixis Clinical Site #132
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Brescia, Italy, 25123
- Exelixis Clinical Site #26
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Meldola, Italy, 47014
- Exelixis Clinical Site #19
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Milan, Italy, 20132
- Exelixis Clinical Site #129
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Naples, Italy, 80131
- Exelixis Clinical Site #30
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Pavia, Italy, 27100
- Exelixis Clinical Site #37
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Pisa, Italy, 56126
- Exelixis Clinical Site #63
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Reggio Emilia, Italy, 42123
- Exelixis Clinical Site #48
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Roma, Italy, 00168
- Exelixis Clinical Site #60
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San Giovanni Rotondo, Italy, 71013
- Exelixis Clinical Site #72
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Verona, Italy, 37134
- Exelixis Clinical Site #17
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Milano
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Rozzano, Milano, Italy, 20089
- Exelixis Clinical Site #130
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Torino
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Candiolo, Torino, Italy, 10060
- Exelixis Clinical Site #131
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Kuala Lumpur, Malaysia, 50586
- Exelixis Clinical Site #54
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Kuala Lumpur, Malaysia, 59100
- Exelixis Clinical Site #24
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Putrajaya, Malaysia, 62250
- Exelixis Clinical Site #46
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Eindhoven, Netherlands, 631BM
- Exelixis Clinical Site #64
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Bydgoszcz, Poland, 85-796
- Exelixis Clinical Site #45
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Gdansk, Poland, 80-219
- Exelixis Clinical Site #49
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Otwock, Poland, 05-400
- Exelixis Clinical Site #33
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Poznan, Poland, 02-781
- Exelixis Clinical Site #77
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Poznan, Poland, 60-569
- Exelixis Clinical Site #133
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Poznan, Poland, 60-693
- Exelixis Clinical Site #80
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Rzeszów, Poland, 35-021
- Exelixis Clinical Site #23
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Singapore, Singapore, 168583
- Exelixis Clinical Site #134
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Banská Bystrica, Slovakia, 97517
- Exelixis Clinical Site #137
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Bratislava, Slovakia, 83310
- Exelixis Clinical Site #135
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Košice, Slovakia, 04190
- Exelixis Clinical Site #136
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Busan, South Korea, 49201
- Exelixis Clinical Site #11
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Busan, South Korea, 49267
- Exelixis Clinical Site #32
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Daegu, South Korea, 42601
- Exelixis Clinical Site #22
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Daejeon, South Korea, 35015
- Exelixis Clinical Site #13
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Goyang-si, South Korea, 10408
- Exelixis Clinical Site #16
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Gyeonggi-do, South Korea, 16247
- Exelixis Clinical Site #25
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Seongnam-si, South Korea, 13496
- Exelixis Clinical Site #21
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Seongnam-si, South Korea, 13620
- Exelixis Clinical Site #5
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Seoul, South Korea, 02841
- Exelixis Clinical Site #10
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Seoul, South Korea, 03722
- Exelixis Clinical Site #4
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Seoul, South Korea, 05505
- Exelixis Clinical Site #47
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Seoul, South Korea, 06351
- Exelixis Clinical Site #6
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Seoul, South Korea, 06591
- Exelixis Clinical Site #20
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Barcelona, Spain, 08035
- Exelixis Clinical Site #56
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Barcelona, Spain, 08036
- Exelixis Clinical Site #9
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Barcelona, Spain, 08041
- Exelixis Clinical Site #52
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Barcelona, Spain, 8906
- Exelixis Clinical Site #138
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Córdoba, Spain, 14004
- Exelixis Clinical Site #141
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Girona, Spain, 17007
- Exelixis Clinical Site #62
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Madrid, Spain, 28009
- Exelixis Clinical Site #139
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Madrid, Spain, 28033
- Exelixis Clinical Site #140
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Madrid, Spain, 28034
- Exelixis Clinical Site #3
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Madrid, Spain, 28041
- Exelixis Clinical Site #34
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Madrid, Spain, 28046
- Exelixis Clinical Site #8
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Málaga, Spain, 29011
- Exelixis Clinical Site #145
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Oviedo, Spain, 33011
- Exelixis Clinical Site #57
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Santander, Spain, 39008
- Exelixis Clinical Site #75
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Seville, Spain, 41009
- Exelixis Clinical Site #144
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Seville, Spain, 41013
- Exelixis Clinical Site #18
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Valencia, Spain, 46009
- Exelixis Clinical Site #73
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spain, 7120
- Exelixis Clinical Site #143
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Madrid
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Majadahonda, Madrid, Spain, 28220
- Exelixis Clinical Site #142
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Bangkok, Thailand, 10330
- Exelixis Clinical Site #84
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Bangkok, Thailand, 10400
- Exelixis Clinical Site #83
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Chiang Mai, Thailand, 50200
- Exelixis Clinical Site #82
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Bangkok
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Bangkok Noi, Bangkok, Thailand, 10400
- Exelixis Clinical Site #147
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Changwat Khon Kaen
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Phu Wiang, Changwat Khon Kaen, Thailand, 40002
- Exelixis Clinical Site #146
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Adana, Turkey (Türkiye), 1140
- Exelixis Clinical Site #157
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Adana, Turkey (Türkiye), 1230
- Exelixis Clinical Site #153
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Ankara, Turkey (Türkiye), 06520
- Exelixis Clinical Site #156
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Ankara, Turkey (Türkiye), 6010
- Exelixis Clinical Site #149
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Ankara, Turkey (Türkiye), 6230
- Exelixis Clinical Site #150
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Ankara, Turkey (Türkiye), 6590
- Exelixis Clinical Site #155
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Ankara, Turkey (Türkiye), 6800
- Exelixis Clinical Site #152
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Istanbul, Turkey (Türkiye), 34722
- Exelixis Clinical Site #151
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Istanbul, Turkey (Türkiye), 34890
- Exelixis Clinical Site #148
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Izmir, Turkey (Türkiye), 35575
- Exelixis Clinical Site #154
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London, United Kingdom, EC1M 6BQ
- Exelixis Clinical Site #160
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London, United Kingdom, SE1 9RT
- Exelixis Clinical Site #159
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S10 2SJ
- Exelixis Clinical Site #158
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California
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Duarte, California, United States, 91010
- Exelixis Clinical Site #1
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Newport Beach, California, United States, 92663
- Exelixis Clinical Site #164
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San Francisco, California, United States, 94115
- Exelixis Clinical Site #162
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Colorado
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Aurora, Colorado, United States, 80045
- Exelixis Clinical Site #163
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Florida
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Jacksonville, Florida, United States, 32209
- Exelixis Clinical Site #55
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New York
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Buffalo, New York, United States, 14263
- Exelixis Clinical Site #161
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New York, New York, United States, 10029
- Exelixis Clinical Site #58
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New York, New York, United States, 10065
- Exelixis Clinical Site #15
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Ohio
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Cleveland, Ohio, United States, 44106
- Exelixis Clinical Site #42
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Texas
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Dallas, Texas, United States, 75246
- Exelixis Clinical Site #31
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: XL092 + Nivolumab
Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
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Specified doses on specified days
Specified doses on specified days
Other Names:
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Active Comparator: Sunitinib Malate
Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib
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Specified doses on specified days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC)
Time Frame: Approximately 27 months after the first subject is randomized
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Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause
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Approximately 27 months after the first subject is randomized
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Objective response rate (ORR) as assessed by BIRC per RECIST 1.1
Time Frame: Up to 24 months after the first subject is randomized
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Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later
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Up to 24 months after the first subject is randomized
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Duration of Overall Survival (OS)
Time Frame: Approximately 46 months after the first subject is randomized
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Defined as the time from randomization to death due to any cause
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Approximately 46 months after the first subject is randomized
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
June 30, 2028
Study Registration Dates
First Submitted
December 23, 2022
First Submitted That Met QC Criteria
December 23, 2022
First Posted (Actual)
January 10, 2023
Study Record Updates
Last Update Posted (Actual)
July 29, 2026
Last Update Submitted That Met QC Criteria
July 28, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Kidney Neoplasms
- Carcinoma
- Carcinoma, Renal Cell
- Amino Acids, Peptides, and Proteins
- Proteins
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Azoles
- Indoles
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Pyrroles
- Sunitinib
- Nivolumab
Other Study ID Numbers
- XL092-304
- EU CTR: 2022-501703-27-0 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.