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

NCT ID: NCT05678673

Condition: Non-Clear Cell Renal Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Nivolumab
Sunitinib

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: XL092
Description: Specified doses on specified days
Arm group label: XL092 + Nivolumab

Intervention type: Drug
Intervention name: Nivolumab
Description: Specified doses on specified days
Arm group label: XL092 + Nivolumab

Other name: Opdivo®

Intervention type: Drug
Intervention name: Sunitinib Malate
Description: Specified doses on specified days
Arm group label: Sunitinib Malate

Other name: Sutent®

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Exelixis Clinical Site #1

Address:
City: Duarte
Zip: 91010
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #55

Address:
City: Jacksonville
Zip: 32209
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #58

Address:
City: New York
Zip: 10029
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #15

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #42

Address:
City: Cleveland
Zip: 44106
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #2

Address:
City: Knoxville
Zip: 37916
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #31

Address:
City: Dallas
Zip: 75246
Country: United States

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #44

Address:
City: Buenos Aires
Zip: B7600FZO
Country: Argentina

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #35

Address:
City: Caba
Zip: C1419GEP
Country: Argentina

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #51

Address:
City: Santa Fe
Zip: 2000
Country: Argentina

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #14

Address:
City: Chermside
Zip: 4032
Country: Australia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #29

Address:
City: South Brisbane
Zip: 4101
Country: Australia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #68

Address:
City: Barretos
Zip: 14784 400
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #39

Address:
City: Itajaí
Zip: 88301-220
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #69

Address:
City: Passo Fundo
Zip: 99010-090
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #70

Address:
City: Porto Alegre
Zip: 90110-270
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #78

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #87

Address:
City: Santo André
Zip: 09060-870
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #43

Address:
City: Sao Paulo
Zip: 17210-120
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #50

Address:
City: São José Do Rio Preto
Zip: 15090-000
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #81

Address:
City: São Paulo
Zip: 01323-001
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #85

Address:
City: São Paulo
Zip: 01323-903
Country: Brazil

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #53

Address:
City: Providencia
Zip: 7520378
Country: Chile

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #61

Address:
City: Brno
Zip: 602 00
Country: Czechia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #27

Address:
City: Praha 4
Zip: 140 59
Country: Czechia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #86

Address:
City: Praha 5
Zip: 150 06
Country: Czechia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #71

Address:
City: Helsinki
Zip: 00290
Country: Finland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #74

Address:
City: Caen Cedex
Zip: 14076
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #66

Address:
City: Clermont-Ferrand
Zip: 63011
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #40

Address:
City: Creteil
Zip: 94010
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #38

Address:
City: Le Mans
Zip: 72000
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #36

Address:
City: Marseille
Zip: 13385
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #67

Address:
City: Paris Cedex
Zip: 75475
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #12

Address:
City: Paris
Zip: 75013
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #76

Address:
City: Pierre-Bénite
Zip: 69310
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #59

Address:
City: Reims cedex
Zip: 51726
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #28

Address:
City: Rennes
Zip: 35042
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #41

Address:
City: Strasbourg
Zip: 67200
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #65

Address:
City: Suresnes
Zip: 92150
Country: France

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #79

Address:
City: Lutherstadt Eisleben
Zip: 06295
Country: Germany

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #7

Address:
City: Arezzo
Zip: 52100
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #26

Address:
City: Brescia
Zip: 25123
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #19

Address:
City: Meldola
Zip: 47014
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #30

Address:
City: Napoli
Zip: 80131
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #37

Address:
City: Pavia
Zip: 27100
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #63

Address:
City: Pisa
Zip: 56126
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #48

Address:
City: Reggio Emilia
Zip: 42123
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #60

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #72

Address:
City: San Giovanni Rotondo
Zip: 71013
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #17

Address:
City: Verona
Zip: 37134
Country: Italy

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #11

Address:
City: Busan
Zip: 49201
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #32

Address:
City: Busan
Zip: 49267
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #22

Address:
City: Daegu
Zip: 42601
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #13

Address:
City: Daejeon
Zip: 35015
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #16

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #25

Address:
City: Gyeonggi-do
Zip: 16247
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #21

Address:
City: Seongnam-si
Zip: 13496
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #5

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #10

Address:
City: Seoul
Zip: 02841
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #4

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #47

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #6

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #20

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #54

Address:
City: Kuala Lumpur
Zip: 50586
Country: Malaysia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #24

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #46

Address:
City: Putrajaya
Zip: 62250
Country: Malaysia

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #64

Address:
City: Eindhoven
Zip: 631BM
Country: Netherlands

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #45

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #49

Address:
City: Gdańsk
Zip: 80-219
Country: Poland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #33

Address:
City: Otwock
Zip: 05-400
Country: Poland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #77

Address:
City: Poznań
Zip: 02-781
Country: Poland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #80

Address:
City: Poznań
Zip: 60-693
Country: Poland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #23

Address:
City: Rzeszow
Zip: 35-021
Country: Poland

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #56

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #9

Address:
City: Barcelona
Zip: 08036
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #52

Address:
City: Barcelona
Zip: 08041
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #62

Address:
City: Girona
Zip: 17007
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #3

Address:
City: Madrid
Zip: 28034
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #34

Address:
City: Madrid
Zip: 28041
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #8

Address:
City: Madrid
Zip: 28046
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #57

Address:
City: Oviedo
Zip: 33011
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #75

Address:
City: Santander
Zip: 39008
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #18

Address:
City: Sevilla
Zip: 41013
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #73

Address:
City: Valencia
Zip: 46009
Country: Spain

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #84

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #83

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Status: Recruiting

Facility:
Name: Exelixis Clinical Site #82

Address:
City: Chiang Mai
Zip: 50200
Country: Thailand

Status: Recruiting

Start date: January 1, 2023

Completion date: June 2028

Lead sponsor:
Agency: Exelixis
Agency class: Industry

Source: Exelixis

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05678673

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