Phase
Condition
Carcinoma
Treatment
XL092
Sunitinib Malate
Nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed nccRCC that is unresectable, advanced or metastatic.Histologic subtypes including papillary, unclassified, and translocation-associatedare allowed. Among the eligible histologic subtypes, sarcomatoid features areallowed.
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 priortreatments unless AE(s) are deemed clinically nonsignificant by the Investigatorand/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 highlyeffective methods of contraception.
Female subjects of childbearing potential must not be pregnant at screening.
Exclusion
Exclusion Criteria:
Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypesof nccRCC.
Prior systemic anticancer therapy for unresectable locally advanced or metastaticnccRCC including investigational agents.
Note: One prior systemic adjuvant therapy, including immune checkpointinhibitor therapy and excluding sunitinib, is allowed for completely resectedRCC and if recurrence occurred at least 6 months after the last dose ofadjuvant therapy.
Radiation therapy for bone metastases within 2 weeks, any other radiation therapywithin 4 weeks prior to randomization.
Known brain metastases or cranial epidural disease unless adequately treated withradiotherapy (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 betransitioned to LMWH prior to randomization. Subjects who require treatment withplatelet inhibitors are not eligible.
Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeksprior to randomization. Prior laparoscopic nephrectomy within 4 weeks prior torandomization. Minor surgery (eg, simple excision, tooth extraction) within 10 daysbefore randomization. Complete wound healing from major or minor surgery must haveoccurred at least prior to randomization.
Note: Fresh tumor biopsies should be performed at least 7 days beforerandomization. Subjects with clinically relevant ongoing complications fromprior surgical procedures, including biopsies, are not eligible.
Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms perelectrocardiogram (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 beadministered at least 2 weeks before randomization.
Study Design
Connect with a study center
Exelixis Clinical Site #88
Pilar, Buenos Aires B1629ODT
ArgentinaSite Not Available
Exelixis Clinical Site #89
Viedma, Rio Negro R8500ACE
ArgentinaSite Not Available
Exelixis Clinical Site #44
Buenos Aires, B7600FZO
ArgentinaSite Not Available
Exelixis Clinical Site #35
Caba, C1419GEP
ArgentinaSite Not Available
Exelixis Clinical Site #90
Córdoba, X5004BAL
ArgentinaSite Not Available
Exelixis Clinical Site #51
Santa Fe, 2000
ArgentinaSite Not Available
Exelixis Clinical Site #94
Albury, New South Wales 2640
AustraliaSite Not Available
Exelixis Clinical Site #97
Camperdown, New South Wales 3021
AustraliaSite Not Available
Exelixis Clinical Site #98
Liverpool, New South Wales 2170
AustraliaSite Not Available
Exelixis Clinical Site #95
Macquarie, New South Wales 2109
AustraliaSite Not Available
Exelixis Clinical Site #92
Sydney, New South Wales 2145
AustraliaSite Not Available
Exelixis Clinical Site #93
Waratah, New South Wales 2298
AustraliaSite Not Available
Exelixis Clinical Site #99
Douglas, Queensland 4814
AustraliaSite Not Available
Exelixis Clinical Site #100
Elizabeth Vale, South Australia 5112
AustraliaSite Not Available
Exelixis Clinical Site #91
Box Hill, Victoria 3128
AustraliaSite Not Available
Exelixis Clinical Site #96
St Albans, Victoria 3021
AustraliaSite Not Available
Exelixis Clinical Site #14
Chermside, 4032
AustraliaSite Not Available
Exelixis Clinical Site #29
South Brisbane, 4101
AustraliaSite Not Available
Exelixis Clinical Site #102
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
Exelixis Clinical Site #68
Barretos, 14784 400
BrazilSite Not Available
Exelixis Clinical Site #39
Itajaí, 88301-220
BrazilSite Not Available
Exelixis Clinical Site #69
Passo Fundo, 99010-090
BrazilSite Not Available
Exelixis Clinical Site #70
Porto Alegre, 90110-270
BrazilSite Not Available
Exelixis Clinical Site #78
Porto Alegre, 91350-200
BrazilSite Not Available
Exelixis Clinical Site #87
Santo André, 09060-870
BrazilSite Not Available
Exelixis Clinical Site #43
Sao Paulo, 17210-120
BrazilSite Not Available
Exelixis Clinical Site #50
São José Do Rio Preto, 15090-000
BrazilSite Not Available
Exelixis Clinical Site #101
São Paulo, 01246-000
BrazilSite Not Available
Exelixis Clinical Site #81
São Paulo, 01323-001
BrazilSite Not Available
Exelixis Clinical Site #85
São Paulo, 01323-903
BrazilSite Not Available
Exelixis Clinical Site #104
Plovdiv, 4004
BulgariaSite Not Available
Exelixis Clinical Site #103
Sofia, 1431
BulgariaSite Not Available
Exelixis Clinical Site #105
Sofia, 1404
BulgariaSite Not Available
Exelixis Clinical Site #53
Providencia, 7520378
ChileSite Not Available
Exelixis Clinical Site #106
Santiago, 7500921
ChileSite Not Available
Exelixis Clinical Site #107
Santiago, 8420383
ChileSite Not Available
Exelixis Clinical Site #108
Santiago, 7520378
ChileSite Not Available
Exelixis Clinical Site #109
Santiago, 8241479
ChileSite Not Available
Exelixis Clinical Site #111
Rijeka, 51000
CroatiaSite Not Available
Exelixis Clinical Site #110
Zagreb, 10000
CroatiaSite Not Available
Exelixis Clinical Site #61
Brno, 602 00
CzechiaSite Not Available
Exelixis Clinical Site #112
Olomouc, 77900
CzechiaSite Not Available
Exelixis Clinical Site #27
Praha 4, 140 59
CzechiaSite Not Available
Exelixis Clinical Site #86
Praha 5, 150 06
CzechiaSite Not Available
Exelixis Clinical Site #71
Helsinki, 00290
FinlandSite Not Available
Exelixis Clinical Site #115
Angers Cedex, Maine Et Loire 49933
FranceSite Not Available
Exelixis Clinical Site #74
Caen Cedex, 14076
FranceSite Not Available
Exelixis Clinical Site #66
Clermont-Ferrand, 63011
FranceSite Not Available
Exelixis Clinical Site #40
Creteil, 94010
FranceSite Not Available
Exelixis Clinical Site #38
Le Mans, 72000
FranceSite Not Available
Exelixis Clinical Site #114
Lille Cedex, 59020
FranceSite Not Available
Exelixis Clinical Site #113
Lyon Cedex, 08Rhone69373
FranceSite Not Available
Exelixis Clinical Site #36
Marseille, 13385
FranceSite Not Available
Exelixis Clinical Site #12
Paris, 75013
FranceSite Not Available
Exelixis Clinical Site #67
Paris Cedex, 75475
FranceSite Not Available
Exelixis Clinical Site #76
Pierre-Bénite, 69310
FranceSite Not Available
Exelixis Clinical Site #59
Reims cedex, 51726
FranceSite Not Available
Exelixis Clinical Site #28
Rennes, 35042
FranceSite Not Available
Exelixis Clinical Site #41
Strasbourg, 67200
FranceSite Not Available
Exelixis Clinical Site #65
Suresnes, 92150
FranceSite Not Available
Exelixis Clinical Site #116
Frankfurt, Hessen 60590
GermanySite Not Available
Exelixis Clinical Site #117
Hamburg, 22763
GermanySite Not Available
Exelixis Clinical Site #79
Lutherstadt Eisleben, 06295
GermanySite Not Available
Exelixis Clinical Site #118
Athens, 11528
GreeceSite Not Available
Exelixis Clinical Site #119
Athens, 12462
GreeceSite Not Available
Exelixis Clinical Site #123
Athens, 12462
GreeceSite Not Available
Exelixis Clinical Site #120
Thessaloníki, 56403
GreeceSite Not Available
Exelixis Clinical Site #121
Thessaloníki, 54622
GreeceSite Not Available
Exelixis Clinical Site #122
Trípoli, 22131
GreeceSite Not Available
Exelixis Clinical Site #124
Hong Kong,
Hong KongSite Not Available
Exelixis Clinical Site #125
Hong Kong,
Hong KongSite Not Available
Exelixis Clinical Site #127
Budapest, 1122
HungarySite Not Available
Exelixis Clinical Site #128
Budapest, 1082
HungarySite Not Available
Exelixis Clinical Site #126
Debrecen, 4032
HungarySite Not Available
Exelixis Clinical Site #130
Rozzano, Milano 20089
ItalySite Not Available
Exelixis Clinical Site #131
Candiolo, Torino 10060
ItalySite Not Available
Exelixis Clinical Site #7
Arezzo, 52100
ItalySite Not Available
Exelixis Clinical Site #132
Bari, 70124
ItalySite Not Available
Exelixis Clinical Site #26
Brescia, 25123
ItalySite Not Available
Exelixis Clinical Site #19
Meldola, 47014
ItalySite Not Available
Exelixis Clinical Site #129
Milano, 20132
ItalySite Not Available
Exelixis Clinical Site #30
Napoli, 80131
ItalySite Not Available
Exelixis Clinical Site #37
Pavia, 27100
ItalySite Not Available
Exelixis Clinical Site #63
Pisa, 56126
ItalySite Not Available
Exelixis Clinical Site #48
Reggio Emilia, 42123
ItalySite Not Available
Exelixis Clinical Site #60
Roma, 00168
ItalySite Not Available
Exelixis Clinical Site #72
San Giovanni Rotondo, 71013
ItalySite Not Available
Exelixis Clinical Site #17
Verona, 37134
ItalySite Not Available
Exelixis Clinical Site #11
Busan, 49201
Korea, Republic ofSite Not Available
Exelixis Clinical Site #32
Busan, 49267
Korea, Republic ofSite Not Available
Exelixis Clinical Site #22
Daegu, 42601
Korea, Republic ofSite Not Available
Exelixis Clinical Site #13
Daejeon, 35015
Korea, Republic ofSite Not Available
Exelixis Clinical Site #16
Goyang-si, 10408
Korea, Republic ofSite Not Available
Exelixis Clinical Site #25
Gyeonggi-do, 16247
Korea, Republic ofSite Not Available
Exelixis Clinical Site #21
Seongnam-si, 13496
Korea, Republic ofSite Not Available
Exelixis Clinical Site #5
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Exelixis Clinical Site #10
Seoul, 02841
Korea, Republic ofSite Not Available
Exelixis Clinical Site #20
Seoul, 06591
Korea, Republic ofSite Not Available
Exelixis Clinical Site #4
Seoul, 03722
Korea, Republic ofSite Not Available
Exelixis Clinical Site #47
Seoul, 05505
Korea, Republic ofSite Not Available
Exelixis Clinical Site #6
Seoul, 06351
Korea, Republic ofSite Not Available
Exelixis Clinical Site #24
Kuala Lumpur, 59100
MalaysiaSite Not Available
Exelixis Clinical Site #54
Kuala Lumpur, 50586
MalaysiaSite Not Available
Exelixis Clinical Site #46
Putrajaya, 62250
MalaysiaSite Not Available
Exelixis Clinical Site #64
Eindhoven, 631BM
NetherlandsSite Not Available
Exelixis Clinical Site #45
Bydgoszcz, 85-796
PolandSite Not Available
Exelixis Clinical Site #49
Gdańsk, 80-219
PolandSite Not Available
Exelixis Clinical Site #33
Otwock, 05-400
PolandSite Not Available
Exelixis Clinical Site #133
Poznań, 60-569
PolandSite Not Available
Exelixis Clinical Site #77
Poznań, 02-781
PolandSite Not Available
Exelixis Clinical Site #80
Poznań, 60-693
PolandSite Not Available
Exelixis Clinical Site #23
Rzeszow, 35-021
PolandSite Not Available
Exelixis Clinical Site #134
Singapore, 168583
SingaporeSite Not Available
Exelixis Clinical Site #137
Banská Bystrica, 97517
SlovakiaSite Not Available
Exelixis Clinical Site #135
Bratislava, 83310
SlovakiaSite Not Available
Exelixis Clinical Site #136
Košice, 04190
SlovakiaSite Not Available
Exelixis Clinical Site #143
Palma De Mallorca, Baleares 7120
SpainSite Not Available
Exelixis Clinical Site #142
Majadahonda, Madrid 28220
SpainSite Not Available
Exelixis Clinical Site #138
Barcelona, 8906
SpainSite Not Available
Exelixis Clinical Site #52
Barcelona, 08041
SpainSite Not Available
Exelixis Clinical Site #56
Barcelona, 08035
SpainSite Not Available
Exelixis Clinical Site #9
Barcelona, 08036
SpainSite Not Available
Exelixis Clinical Site #141
Córdoba, 14004
SpainSite Not Available
Exelixis Clinical Site #62
Girona, 17007
SpainSite Not Available
Exelixis Clinical Site #139
Madrid, 28009
SpainSite Not Available
Exelixis Clinical Site #140
Madrid, 28033
SpainSite Not Available
Exelixis Clinical Site #3
Madrid, 28034
SpainSite Not Available
Exelixis Clinical Site #34
Madrid, 28041
SpainSite Not Available
Exelixis Clinical Site #8
Madrid, 28046
SpainSite Not Available
Exelixis Clinical Site #145
Málaga, 29011
SpainSite Not Available
Exelixis Clinical Site #57
Oviedo, 33011
SpainSite Not Available
Exelixis Clinical Site #75
Santander, 39008
SpainSite Not Available
Exelixis Clinical Site #144
Sevilla, 41009
SpainSite Not Available
Exelixis Clinical Site #18
Sevilla, 41013
SpainSite Not Available
Exelixis Clinical Site #73
Valencia, 46009
SpainSite Not Available
Exelixis Clinical Site #147
Bangkok Noi, Bangkok 10400
ThailandSite Not Available
Exelixis Clinical Site #146
Nai Muang, Khon Kaen 40002
ThailandSite Not Available
Exelixis Clinical Site #83
Bangkok, 10400
ThailandSite Not Available
Exelixis Clinical Site #84
Bangkok, 10330
ThailandSite Not Available
Exelixis Clinical Site #82
Chiang Mai, 50200
ThailandSite Not Available
Exelixis Clinical Site #153
Adana, 1230
TurkeySite Not Available
Exelixis Clinical Site #157
Adana, 1140
TurkeySite Not Available
Exelixis Clinical Site #149
Ankara, 6010
TurkeySite Not Available
Exelixis Clinical Site #150
Ankara, 6230
TurkeySite Not Available
Exelixis Clinical Site #152
Ankara, 6800
TurkeySite Not Available
Exelixis Clinical Site #155
Ankara, 6590
TurkeySite Not Available
Exelixis Clinical Site #156
Ankara, 06520
TurkeySite Not Available
Exelixis Clinical Site #148
Istanbul, 34890
TurkeySite Not Available
Exelixis Clinical Site #151
Istanbul, 34722
TurkeySite Not Available
Exelixis Clinical Site #154
İzmir, 35575
TurkeySite Not Available
Exelixis Clinical Site #158
Sheffield, South Yorkshire S10 2SJ
United KingdomSite Not Available
Exelixis Clinical Site #159
London, SE1 9RT
United KingdomSite Not Available
Exelixis Clinical Site #160
London, EC1M 6BQ
United KingdomSite Not Available
Exelixis Clinical Site #1
Duarte, California 91010
United StatesSite Not Available
Exelixis Clinical Site #164
Newport Beach, California 92663
United StatesSite Not Available
Exelixis Clinical Site #162
San Francisco, California 94115
United StatesSite Not Available
Exelixis Clinical Site #163
Aurora, Colorado 80045
United StatesSite Not Available
Exelixis Clinical Site #55
Jacksonville, Florida 32209
United StatesSite Not Available
Exelixis Clinical Site #161
Buffalo, New York 14263
United StatesSite Not Available
Exelixis Clinical Site #15
New York, New York 10065
United StatesSite Not Available
Exelixis Clinical Site #58
New York, New York 10029
United StatesSite Not Available
Exelixis Clinical Site #42
Cleveland, Ohio 44106
United StatesSite Not Available
Exelixis Clinical Site #2
Knoxville, Tennessee 37916
United StatesSite Not Available
Exelixis Clinical Site #31
Dallas, Texas 75246
United StatesSite Not Available
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