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
