Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (STELLAR-304)

July 11, 2025 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

  • Argentina
      • Buenos Aires, Argentina, B7600FZO
        • Exelixis Clinical Site #44
      • Caba, Argentina, C1419GEP
        • Exelixis Clinical Site #35
      • Córdoba, Argentina, X5004BAL
        • Exelixis Clinical Site #90
      • Santa Fe, Argentina, 2000
        • Exelixis Clinical Site #51
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Exelixis Clinical Site #88
    • Rio Negro
      • Viedma, Rio Negro, Argentina, R8500ACE
        • Exelixis Clinical Site #89
  • Australia
      • Chermside, Australia, 4032
        • Exelixis Clinical Site #14
      • South Brisbane, Australia, 4101
        • Exelixis Clinical Site #29
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Exelixis Clinical Site #94
      • Camperdown, New South Wales, Australia, 3021
        • Exelixis Clinical Site #97
      • Liverpool, New South Wales, Australia, 2170
        • Exelixis Clinical Site #98
      • Macquarie, New South Wales, Australia, 2109
        • Exelixis Clinical Site #95
      • Sydney, New South Wales, Australia, 2145
        • Exelixis Clinical Site #92
      • Waratah, New South Wales, Australia, 2298
        • Exelixis Clinical Site #93
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Exelixis Clinical Site #99
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Exelixis Clinical Site #100
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Exelixis Clinical Site #91
      • St Albans, Victoria, Australia, 3021
        • Exelixis Clinical Site #96
  • Brazil
      • Barretos, Brazil, 14784 400
        • Exelixis Clinical Site #68
      • Itajaí, Brazil, 88301-220
        • Exelixis Clinical Site #39
      • Passo Fundo, Brazil, 99010-090
        • Exelixis Clinical Site #69
      • Porto Alegre, Brazil, 90110-270
        • Exelixis Clinical Site #70
      • Porto Alegre, Brazil, 91350-200
        • Exelixis Clinical Site #78
      • Santo André, Brazil, 09060-870
        • Exelixis Clinical Site #87
      • Sao Paulo, Brazil, 17210-120
        • Exelixis Clinical Site #43
      • São José Do Rio Preto, Brazil, 15090-000
        • Exelixis Clinical Site #50
      • São Paulo, Brazil, 01246-000
        • Exelixis Clinical Site #101
      • São Paulo, Brazil, 01323-001
        • Exelixis Clinical Site #81
      • São Paulo, Brazil, 01323-903
        • Exelixis Clinical Site #85
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Exelixis Clinical Site #102
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Exelixis Clinical Site #104
      • Sofia, Bulgaria, 1404
        • Exelixis Clinical Site #105
      • Sofia, Bulgaria, 1431
        • Exelixis Clinical Site #103
  • Chile
      • Providencia, Chile, 7520378
        • Exelixis Clinical Site #53
      • Santiago, Chile, 7500921
        • Exelixis Clinical Site #106
      • Santiago, Chile, 7520378
        • Exelixis Clinical Site #108
      • Santiago, Chile, 8241479
        • Exelixis Clinical Site #109
      • Santiago, Chile, 8420383
        • Exelixis Clinical Site #107
  • Croatia
      • Rijeka, Croatia, 51000
        • Exelixis Clinical Site #111
      • Zagreb, Croatia, 10000
        • Exelixis Clinical Site #110
  • Czechia
      • Brno, Czechia, 602 00
        • Exelixis Clinical Site #61
      • Olomouc, Czechia, 77900
        • Exelixis Clinical Site #112
      • Praha 4, Czechia, 140 59
        • Exelixis Clinical Site #27
      • Praha 5, Czechia, 150 06
        • Exelixis Clinical Site #86
  • Finland
      • Helsinki, Finland, 00290
        • Exelixis Clinical Site #71
  • France
      • Caen Cedex, France, 14076
        • Exelixis Clinical Site #74
      • Clermont-Ferrand, France, 63011
        • Exelixis Clinical Site #66
      • Creteil, France, 94010
        • Exelixis Clinical Site #40
      • Le Mans, France, 72000
        • Exelixis Clinical Site #38
      • Lille Cedex, France, 59020
        • Exelixis Clinical Site #114
      • Lyon Cedex, France, 08Rhone69373
        • Exelixis Clinical Site #113
      • Marseille, France, 13385
        • Exelixis Clinical Site #36
      • Paris, France, 75013
        • Exelixis Clinical Site #12
      • Paris Cedex, France, 75475
        • Exelixis Clinical Site #67
      • Pierre-Bénite, France, 69310
        • Exelixis Clinical Site #76
      • Reims cedex, France, 51726
        • Exelixis Clinical Site #59
      • Rennes, France, 35042
        • Exelixis Clinical Site #28
      • Strasbourg, France, 67200
        • Exelixis Clinical Site #41
      • Suresnes, France, 92150
        • Exelixis Clinical Site #65
    • Maine Et Loire
      • Angers Cedex, Maine Et Loire, France, 49933
        • Exelixis Clinical Site #115
  • Germany
      • Hamburg, Germany, 22763
        • Exelixis Clinical Site #117
      • Lutherstadt Eisleben, Germany, 06295
        • Exelixis Clinical Site #79
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Exelixis Clinical Site #116
  • Greece
      • Athens, Greece, 11528
        • Exelixis Clinical Site #118
      • Athens, Greece, 12462
        • Exelixis Clinical Site #119
      • Athens, Greece, 12462
        • Exelixis Clinical Site #123
      • Thessaloníki, Greece, 54622
        • Exelixis Clinical Site #121
      • Thessaloníki, Greece, 56403
        • Exelixis Clinical Site #120
      • Trípoli, Greece, 22131
        • Exelixis Clinical Site #122
  • Hong Kong
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #124
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #125
  • Hungary
      • Budapest, Hungary, 1082
        • Exelixis Clinical Site #128
      • Budapest, Hungary, 1122
        • Exelixis Clinical Site #127
      • Debrecen, Hungary, 4032
        • Exelixis Clinical Site #126
  • Italy
      • Arezzo, Italy, 52100
        • Exelixis Clinical Site #7
      • Bari, Italy, 70124
        • Exelixis Clinical Site #132
      • Brescia, Italy, 25123
        • Exelixis Clinical Site #26
      • Meldola, Italy, 47014
        • Exelixis Clinical Site #19
      • Milano, Italy, 20132
        • Exelixis Clinical Site #129
      • Napoli, Italy, 80131
        • Exelixis Clinical Site #30
      • Pavia, Italy, 27100
        • Exelixis Clinical Site #37
      • Pisa, Italy, 56126
        • Exelixis Clinical Site #63
      • Reggio Emilia, Italy, 42123
        • Exelixis Clinical Site #48
      • Roma, Italy, 00168
        • Exelixis Clinical Site #60
      • San Giovanni Rotondo, Italy, 71013
        • Exelixis Clinical Site #72
      • Verona, Italy, 37134
        • Exelixis Clinical Site #17
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Exelixis Clinical Site #130
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Exelixis Clinical Site #131
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Exelixis Clinical Site #11
      • Busan, Korea, Republic of, 49267
        • Exelixis Clinical Site #32
      • Daegu, Korea, Republic of, 42601
        • Exelixis Clinical Site #22
      • Daejeon, Korea, Republic of, 35015
        • Exelixis Clinical Site #13
      • Goyang-si, Korea, Republic of, 10408
        • Exelixis Clinical Site #16
      • Gyeonggi-do, Korea, Republic of, 16247
        • Exelixis Clinical Site #25
      • Seongnam-si, Korea, Republic of, 13496
        • Exelixis Clinical Site #21
      • Seongnam-si, Korea, Republic of, 13620
        • Exelixis Clinical Site #5
      • Seoul, Korea, Republic of, 02841
        • Exelixis Clinical Site #10
      • Seoul, Korea, Republic of, 03722
        • Exelixis Clinical Site #4
      • Seoul, Korea, Republic of, 05505
        • Exelixis Clinical Site #47
      • Seoul, Korea, Republic of, 06351
        • Exelixis Clinical Site #6
      • Seoul, Korea, Republic of, 06591
        • Exelixis Clinical Site #20
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Exelixis Clinical Site #54
      • Kuala Lumpur, Malaysia, 59100
        • Exelixis Clinical Site #24
      • Putrajaya, Malaysia, 62250
        • Exelixis Clinical Site #46
  • Netherlands
      • Eindhoven, Netherlands, 631BM
        • Exelixis Clinical Site #64
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Exelixis Clinical Site #45
      • Gdańsk, Poland, 80-219
        • Exelixis Clinical Site #49
      • Otwock, Poland, 05-400
        • Exelixis Clinical Site #33
      • Poznań, Poland, 02-781
        • Exelixis Clinical Site #77
      • Poznań, Poland, 60-569
        • Exelixis Clinical Site #133
      • Poznań, Poland, 60-693
        • Exelixis Clinical Site #80
      • Rzeszow, Poland, 35-021
        • Exelixis Clinical Site #23
  • Singapore
      • Singapore, Singapore, 168583
        • Exelixis Clinical Site #134
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Exelixis Clinical Site #137
      • Bratislava, Slovakia, 83310
        • Exelixis Clinical Site #135
      • Košice, Slovakia, 04190
        • Exelixis Clinical Site #136
  • Spain
      • Barcelona, Spain, 08035
        • Exelixis Clinical Site #56
      • Barcelona, Spain, 08036
        • Exelixis Clinical Site #9
      • Barcelona, Spain, 08041
        • Exelixis Clinical Site #52
      • Barcelona, Spain, 8906
        • Exelixis Clinical Site #138
      • Córdoba, Spain, 14004
        • Exelixis Clinical Site #141
      • Girona, Spain, 17007
        • Exelixis Clinical Site #62
      • Madrid, Spain, 28009
        • Exelixis Clinical Site #139
      • Madrid, Spain, 28033
        • Exelixis Clinical Site #140
      • Madrid, Spain, 28034
        • Exelixis Clinical Site #3
      • Madrid, Spain, 28041
        • Exelixis Clinical Site #34
      • Madrid, Spain, 28046
        • Exelixis Clinical Site #8
      • Málaga, Spain, 29011
        • Exelixis Clinical Site #145
      • Oviedo, Spain, 33011
        • Exelixis Clinical Site #57
      • Santander, Spain, 39008
        • Exelixis Clinical Site #75
      • Sevilla, Spain, 41009
        • Exelixis Clinical Site #144
      • Sevilla, Spain, 41013
        • Exelixis Clinical Site #18
      • Valencia, Spain, 46009
        • Exelixis Clinical Site #73
    • Baleares
      • Palma De Mallorca, Baleares, Spain, 7120
        • Exelixis Clinical Site #143
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Exelixis Clinical Site #142
  • Thailand
      • Bangkok, Thailand, 10330
        • Exelixis Clinical Site #84
      • Bangkok, Thailand, 10400
        • Exelixis Clinical Site #83
      • Chiang Mai, Thailand, 50200
        • Exelixis Clinical Site #82
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10400
        • Exelixis Clinical Site #147
    • Khon Kaen
      • Nai Muang, Khon Kaen, Thailand, 40002
        • Exelixis Clinical Site #146
  • Turkey
      • Adana, Turkey, 1140
        • Exelixis Clinical Site #157
      • Adana, Turkey, 1230
        • Exelixis Clinical Site #153
      • Ankara, Turkey, 06520
        • Exelixis Clinical Site #156
      • Ankara, Turkey, 6010
        • Exelixis Clinical Site #149
      • Ankara, Turkey, 6230
        • Exelixis Clinical Site #150
      • Ankara, Turkey, 6590
        • Exelixis Clinical Site #155
      • Ankara, Turkey, 6800
        • Exelixis Clinical Site #152
      • Istanbul, Turkey, 34722
        • Exelixis Clinical Site #151
      • Istanbul, Turkey, 34890
        • Exelixis Clinical Site #148
      • İzmir, Turkey, 35575
        • Exelixis Clinical Site #154
  • United Kingdom
      • London, United Kingdom, EC1M 6BQ
        • Exelixis Clinical Site #160
      • London, United Kingdom, SE1 9RT
        • Exelixis Clinical Site #159
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2SJ
        • Exelixis Clinical Site #158
  • United States
    • California
      • Duarte, California, United States, 91010
        • Exelixis Clinical Site #1
      • Newport Beach, California, United States, 92663
        • Exelixis Clinical Site #164
      • San Francisco, California, United States, 94115
        • Exelixis Clinical Site #162
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Exelixis Clinical Site #163
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Exelixis Clinical Site #55
    • New York
      • Buffalo, New York, United States, 14263
        • Exelixis Clinical Site #161
      • New York, New York, United States, 10029
        • Exelixis Clinical Site #58
      • New York, New York, United States, 10065
        • Exelixis Clinical Site #15
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Exelixis Clinical Site #42
    • Texas
      • Dallas, Texas, United States, 75246
        • Exelixis Clinical Site #31

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
Experimental: XL092 + Nivolumab
Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
Drug: XL092
Specified doses on specified days
Drug: Nivolumab
Specified doses on specified days
Other Names:
  • Opdivo®
Active Comparator: Sunitinib Malate
Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib
Drug: Sunitinib Malate
Specified doses on specified days
Other Names:
  • Sutent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Approximately 27 months after the first subject is randomized
Objective response rate (ORR) as assessed by BIRC per RECIST 1.1
Time Frame: Up to 24 months after the first subject is randomized
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
Up to 24 months after the first subject is randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Overall Survival (OS)
Time Frame: Approximately 46 months after the first subject is randomized
Defined as the time from randomization to death due to any cause
Approximately 46 months after the first subject is randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

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)

July 1, 2025

Study Completion (Estimated)

June 1, 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 14, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.

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