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Non-Clear Cell Renal Cell CarcinomaPhase 3STELLAR-304NCT05678673

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

A Phase 3 study testing XL092, Nivolumab and Sunitinib Malate in people with Non-Clear Cell Renal Cell Carcinoma, run by Exelixis at 163 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Clear Cell Renal Cell Carcinoma
What is being tested?
XL092, Nivolumab and Sunitinib Malate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
163 sitesin 25 countries
Study dates
1 Jan 2023to 30 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

163 sites in 25 countries.

163 sites in 25 countries

Spain19 sites

  • Exelixis Clinical Site #56

    Barcelona, 08035

  • Exelixis Clinical Site #9

    Barcelona, 08036

  • Exelixis Clinical Site #52

    Barcelona, 08041

  • Exelixis Clinical Site #138

    Barcelona, 8906

  • Exelixis Clinical Site #141

    Córdoba, 14004

  • Exelixis Clinical Site #62

    Girona, 17007

  • Exelixis Clinical Site #139

    Madrid, 28009

  • Exelixis Clinical Site #140

    Madrid, 28033

  • Exelixis Clinical Site #3

    Madrid, 28034

  • Exelixis Clinical Site #34

    Madrid, 28041

  • Exelixis Clinical Site #8

    Madrid, 28046

  • Exelixis Clinical Site #142

    Majadahonda, Madrid, 28220

  • Exelixis Clinical Site #145

    Málaga, 29011

  • Exelixis Clinical Site #57

    Oviedo, 33011

  • Exelixis Clinical Site #143

    Palma de Mallorca, Balearic Islands, 7120

  • Exelixis Clinical Site #75

    Santander, 39008

  • Exelixis Clinical Site #144

    Seville, 41009

  • Exelixis Clinical Site #18

    Seville, 41013

  • Exelixis Clinical Site #73

    Valencia, 46009

Other trials in Spain

France15 sites

  • Exelixis Clinical Site #115

    Angers, Maine Et Loire, 49933

  • Exelixis Clinical Site #74

    Caen, 14076

  • Exelixis Clinical Site #66

    Clermont-Ferrand, 63011

  • Exelixis Clinical Site #40

    Créteil, 94010

  • Exelixis Clinical Site #38

    Le Mans, 72000

  • Exelixis Clinical Site #114

    Lille, 59020

  • Exelixis Clinical Site #113

    Lyon, 08Rhone69373

  • Exelixis Clinical Site #36

    Marseille, 13385

  • Exelixis Clinical Site #12

    Paris, 75013

  • Exelixis Clinical Site #67

    Paris, 75475

  • Exelixis Clinical Site #76

    Pierre-Bénite, 69310

  • Exelixis Clinical Site #59

    Reims, 51726

  • Exelixis Clinical Site #28

    Rennes, 35042

  • Exelixis Clinical Site #41

    Strasbourg, 67200

  • Exelixis Clinical Site #65

    Suresnes, 92150

Other trials in France

Italy14 sites

  • Exelixis Clinical Site #7

    Arezzo, 52100

  • Exelixis Clinical Site #132

    Bari, 70124

  • Exelixis Clinical Site #26

    Brescia, 25123

  • Exelixis Clinical Site #131

    Candiolo, Torino, 10060

  • Exelixis Clinical Site #19

    Meldola, 47014

  • Exelixis Clinical Site #129

    Milan, 20132

  • Exelixis Clinical Site #30

    Naples, 80131

  • Exelixis Clinical Site #37

    Pavia, 27100

  • Exelixis Clinical Site #63

    Pisa, 56126

  • Exelixis Clinical Site #48

    Reggio Emilia, 42123

  • Exelixis Clinical Site #60

    Roma, 00168

  • Exelixis Clinical Site #130

    Rozzano, Milano, 20089

  • Exelixis Clinical Site #72

    San Giovanni Rotondo, 71013

  • Exelixis Clinical Site #17

    Verona, 37134

Other trials in Italy

South Korea13 sites

  • Exelixis Clinical Site #11

    Busan, 49201

  • Exelixis Clinical Site #32

    Busan, 49267

  • Exelixis Clinical Site #22

    Daegu, 42601

  • Exelixis Clinical Site #13

    Daejeon, 35015

  • Exelixis Clinical Site #16

    Goyang-si, 10408

  • Exelixis Clinical Site #25

    Gyeonggi-do, 16247

  • Exelixis Clinical Site #21

    Seongnam-si, 13496

  • Exelixis Clinical Site #5

    Seongnam-si, 13620

  • Exelixis Clinical Site #10

    Seoul, 02841

  • Exelixis Clinical Site #4

    Seoul, 03722

  • Exelixis Clinical Site #47

    Seoul, 05505

  • Exelixis Clinical Site #6

    Seoul, 06351

  • Exelixis Clinical Site #20

    Seoul, 06591

Other trials in South Korea

Australia12 sites

  • Exelixis Clinical Site #94

    Albury, New South Wales, 2640

  • Exelixis Clinical Site #91

    Box Hill, Victoria, 3128

  • Exelixis Clinical Site #97

    Camperdown, New South Wales, 3021

  • Exelixis Clinical Site #14

    Chermside, 4032

  • Exelixis Clinical Site #99

    Douglas, Queensland, 4814

  • Exelixis Clinical Site #100

    Elizabeth Vale, South Australia, 5112

  • Exelixis Clinical Site #98

    Liverpool, New South Wales, 2170

  • Exelixis Clinical Site #95

    Macquarie, New South Wales, 2109

  • Exelixis Clinical Site #29

    South Brisbane, 4101

  • Exelixis Clinical Site #96

    St Albans, Victoria, 3021

  • Exelixis Clinical Site #92

    Sydney, New South Wales, 2145

  • Exelixis Clinical Site #93

    Waratah, New South Wales, 2298

Other trials in Australia

Brazil12 sites

  • Exelixis Clinical Site #68

    Barretos, 14784 400

  • Exelixis Clinical Site #39

    Itajaí, 88301-220

  • Exelixis Clinical Site #69

    Passo Fundo, 99010-090

  • Exelixis Clinical Site #102

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Exelixis Clinical Site #70

    Porto Alegre, 90110-270

  • Exelixis Clinical Site #78

    Porto Alegre, 91350-200

  • Exelixis Clinical Site #87

    Santo André, 09060-870

  • Exelixis Clinical Site #50

    São José do Rio Preto, 15090-000

  • Exelixis Clinical Site #101

    São Paulo, 01246-000

  • Exelixis Clinical Site #81

    São Paulo, 01323-001

  • Exelixis Clinical Site #85

    São Paulo, 01323-903

  • Exelixis Clinical Site #43

    São Paulo, 17210-120

Other trials in Brazil

United States10 sites

  • Exelixis Clinical Site #163

    Aurora, Colorado, 80045

  • Exelixis Clinical Site #161

    Buffalo, New York, 14263

  • Exelixis Clinical Site #42

    Cleveland, Ohio, 44106

  • Exelixis Clinical Site #31

    Dallas, Texas, 75246

  • Exelixis Clinical Site #1

    Duarte, California, 91010

  • Exelixis Clinical Site #55

    Jacksonville, Florida, 32209

  • Exelixis Clinical Site #58

    New York, New York, 10029

  • Exelixis Clinical Site #15

    New York, New York, 10065

  • Exelixis Clinical Site #164

    Newport Beach, California, 92663

  • Exelixis Clinical Site #162

    San Francisco, California, 94115

Other trials in United States

Turkey (Türkiye)10 sites

  • Exelixis Clinical Site #157

    Adana, 1140

  • Exelixis Clinical Site #153

    Adana, 1230

  • Exelixis Clinical Site #156

    Ankara, 06520

  • Exelixis Clinical Site #149

    Ankara, 6010

  • Exelixis Clinical Site #150

    Ankara, 6230

  • Exelixis Clinical Site #155

    Ankara, 6590

  • Exelixis Clinical Site #152

    Ankara, 6800

  • Exelixis Clinical Site #151

    Istanbul, 34722

  • Exelixis Clinical Site #148

    Istanbul, 34890

  • Exelixis Clinical Site #154

    Izmir, 35575

Other trials in Turkey (Türkiye)

Poland7 sites

  • Exelixis Clinical Site #45

    Bydgoszcz, 85-796

  • Exelixis Clinical Site #49

    Gdansk, 80-219

  • Exelixis Clinical Site #33

    Otwock, 05-400

  • Exelixis Clinical Site #77

    Poznan, 02-781

  • Exelixis Clinical Site #133

    Poznan, 60-569

  • Exelixis Clinical Site #80

    Poznan, 60-693

  • Exelixis Clinical Site #23

    Rzeszów, 35-021

Other trials in Poland

Argentina6 sites

  • Exelixis Clinical Site #44

    Buenos Aires, B7600FZO

  • Exelixis Clinical Site #35

    CABA, C1419GEP

  • Exelixis Clinical Site #90

    Córdoba, X5004BAL

  • Exelixis Clinical Site #88

    Pilar, Buenos Aires, B1629ODT

  • Exelixis Clinical Site #51

    Santa Fe, 2000

  • Exelixis Clinical Site #89

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Greece6 sites

  • Exelixis Clinical Site #118

    Athens, 11528

  • Exelixis Clinical Site #119

    Athens, 12462

  • Exelixis Clinical Site #123

    Athens, 12462

  • Exelixis Clinical Site #121

    Thessaloniki, 54622

  • Exelixis Clinical Site #120

    Thessaloniki, 56403

  • Exelixis Clinical Site #122

    Tripoli, 22131

Other trials in Greece

Chile5 sites

  • Exelixis Clinical Site #53

    Providencia, 7520378

  • Exelixis Clinical Site #106

    Santiago, 7500921

  • Exelixis Clinical Site #108

    Santiago, 7520378

  • Exelixis Clinical Site #109

    Santiago, 8241479

  • Exelixis Clinical Site #107

    Santiago, 8420383

Other trials in Chile

Thailand5 sites

  • Exelixis Clinical Site #84

    Bangkok, 10330

  • Exelixis Clinical Site #83

    Bangkok, 10400

  • Exelixis Clinical Site #147

    Bangkok Noi, Bangkok, 10400

  • Exelixis Clinical Site #82

    Chiang Mai, 50200

  • Exelixis Clinical Site #146

    Phu Wiang, Changwat Khon Kaen, 40002

Other trials in Thailand

Czechia4 sites

  • Exelixis Clinical Site #61

    Brno, 602 00

  • Exelixis Clinical Site #112

    Olomouc, 77900

  • Exelixis Clinical Site #27

    Prague, 140 59

  • Exelixis Clinical Site #86

    Prague, 150 06

Other trials in Czechia

Bulgaria3 sites

  • Exelixis Clinical Site #104

    Plovdiv, 4004

  • Exelixis Clinical Site #105

    Sofia, 1404

  • Exelixis Clinical Site #103

    Sofia, 1431

Other trials in Bulgaria

Germany3 sites

  • Exelixis Clinical Site #79

    Eisleben Lutherstadt, 06295

  • Exelixis Clinical Site #116

    Frankfurt am Main, Hesse, 60590

  • Exelixis Clinical Site #117

    Hamburg, 22763

Other trials in Germany

Hungary3 sites

  • Exelixis Clinical Site #128

    Budapest, 1082

  • Exelixis Clinical Site #127

    Budapest, 1122

  • Exelixis Clinical Site #126

    Debrecen, 4032

Other trials in Hungary

Malaysia3 sites

  • Exelixis Clinical Site #54

    Kuala Lumpur, 50586

  • Exelixis Clinical Site #24

    Kuala Lumpur, 59100

  • Exelixis Clinical Site #46

    Putrajaya, 62250

Other trials in Malaysia

Slovakia3 sites

  • Exelixis Clinical Site #137

    Banská Bystrica, 97517

  • Exelixis Clinical Site #135

    Bratislava, 83310

  • Exelixis Clinical Site #136

    Košice, 04190

Other trials in Slovakia

United Kingdom3 sites

  • Exelixis Clinical Site #160

    London, EC1M 6BQ

  • Exelixis Clinical Site #159

    London, SE1 9RT

  • Exelixis Clinical Site #158

    Sheffield, South Yorkshire, S10 2SJ

Other trials in United Kingdom

Croatia2 sites

  • Exelixis Clinical Site #111

    Rijeka, 51000

  • Exelixis Clinical Site #110

    Zagreb, 10000

Other trials in Croatia

Hong Kong2 sites

  • Exelixis Clinical Site #124

    Hong Kong

  • Exelixis Clinical Site #125

    Hong Kong

Other trials in Hong Kong

Finland1 site

  • Exelixis Clinical Site #71

    Helsinki, 00290

Other trials in Finland

Netherlands1 site

  • Exelixis Clinical Site #64

    Eindhoven, 631BM

Other trials in Netherlands

Singapore1 site

  • Exelixis Clinical Site #134

    Singapore, 168583

Other trials in Singapore

About this study

Official title: 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.

Being tested
XL092, Nivolumab, Sunitinib Malate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XL092Drug

    Specified doses on specified days

  • NivolumabDrug

    Also called Opdivo®

    Specified doses on specified days

  • Sunitinib MalateDrug

    Also called Sutent®

    Specified doses on specified days

Study groups in NCT05678673
Study groupRoleWhat they receive
XL092 + NivolumabExperimentalSubjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
Receives: Drug: XL092; Drug: Nivolumab
Sunitinib MalateActive comparatorSubjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib
Receives: Drug: Sunitinib Malate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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

    Measured: Approximately 27 months after the first subject is randomized

  2. Objective response rate (ORR) as assessed by BIRC per RECIST 1.1

    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

    Measured: Up to 24 months after the first subject is randomized

Secondary outcomes (1)

  1. Duration of Overall Survival (OS)

    Defined as the time from randomization to death due to any cause

    Measured: Approximately 46 months after the first subject is randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start1 Jan 2023
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05678673
Sponsor's protocol ID
XL092-304
Other IDs
EU CTR: 2022-501703-27-0
Acronym
STELLAR-304
Status last verified
Jul 2026
First submitted
23 Dec 2022
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pal SK, Powles T, Kanesvaran R, Molina-Cerrillo J, Feldman DR, Barata P, Liu M, Bhatt A, Wang Z, Nandoskar P, Suarez C. STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma. Future Oncol. 2025 Mar;21(7):787-794. doi: 10.1080/14796694.2025.2458395. Epub 2025 Feb 26.

    PubMed 40008409

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XL092, Nivolumab and Sunitinib Malate in people with Non-Clear Cell Renal Cell Carcinoma, run by Exelixis at 163 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Spain, France, Italy, South Korea, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678673, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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