Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05678673




Registration number
NCT05678673
Ethics application status
Date submitted
23/12/2022
Date registered
10/01/2023
Date last updated
12/01/2024

Titles & IDs
Public title
Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
EU CTR: 2022-501703-27-0
Secondary ID [2] 0 0
XL092-304
Universal Trial Number (UTN)
Trial acronym
STELLAR-304
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Clear Cell Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XL092
Treatment: Drugs - Nivolumab
Treatment: Drugs - Sunitinib Malate

Experimental: XL092 + Nivolumab - Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab

Active Comparator: Sunitinib Malate - Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib


Treatment: Drugs: XL092
Specified doses on specified days

Treatment: Drugs: Nivolumab
Specified doses on specified days

Treatment: Drugs: Sunitinib Malate
Specified doses on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Approximately 27 months after the first subject is randomized
Primary outcome [2] 0 0
Objective response rate (ORR) as assessed by BIRC per RECIST 1.1
Timepoint [2] 0 0
Up to 24 months after the first subject is randomized
Secondary outcome [1] 0 0
Duration of Overall Survival (OS)
Timepoint [1] 0 0
Approximately 46 months after the first subject is randomized

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
291
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Exelixis Clinical Site #14 - Chermside
Recruitment hospital [2] 0 0
Exelixis Clinical Site #29 - South Brisbane
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Caba
Country [9] 0 0
Argentina
State/province [9] 0 0
Santa Fe
Country [10] 0 0
Brazil
State/province [10] 0 0
Barretos
Country [11] 0 0
Brazil
State/province [11] 0 0
Itajaí
Country [12] 0 0
Brazil
State/province [12] 0 0
Passo Fundo
Country [13] 0 0
Brazil
State/province [13] 0 0
Porto Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Santo André
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Brazil
State/province [16] 0 0
São José Do Rio Preto
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Chile
State/province [18] 0 0
Providencia
Country [19] 0 0
Czechia
State/province [19] 0 0
Brno
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha 4
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 5
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
France
State/province [23] 0 0
Caen Cedex
Country [24] 0 0
France
State/province [24] 0 0
Clermont-Ferrand
Country [25] 0 0
France
State/province [25] 0 0
Creteil
Country [26] 0 0
France
State/province [26] 0 0
Le Mans
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Paris Cedex
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Pierre-Bénite
Country [31] 0 0
France
State/province [31] 0 0
Reims cedex
Country [32] 0 0
France
State/province [32] 0 0
Rennes
Country [33] 0 0
France
State/province [33] 0 0
Strasbourg
Country [34] 0 0
France
State/province [34] 0 0
Suresnes
Country [35] 0 0
Germany
State/province [35] 0 0
Lutherstadt Eisleben
Country [36] 0 0
Italy
State/province [36] 0 0
Arezzo
Country [37] 0 0
Italy
State/province [37] 0 0
Brescia
Country [38] 0 0
Italy
State/province [38] 0 0
Meldola
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Italy
State/province [40] 0 0
Pavia
Country [41] 0 0
Italy
State/province [41] 0 0
Pisa
Country [42] 0 0
Italy
State/province [42] 0 0
Reggio Emilia
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Italy
State/province [44] 0 0
San Giovanni Rotondo
Country [45] 0 0
Italy
State/province [45] 0 0
Verona
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Busan
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Daegu
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daejeon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Goyang-si
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Gyeonggi-do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seongnam-si
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seoul
Country [53] 0 0
Malaysia
State/province [53] 0 0
Kuala Lumpur
Country [54] 0 0
Malaysia
State/province [54] 0 0
Putrajaya
Country [55] 0 0
Netherlands
State/province [55] 0 0
Eindhoven
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Gdansk
Country [58] 0 0
Poland
State/province [58] 0 0
Otwock
Country [59] 0 0
Poland
State/province [59] 0 0
Poznan
Country [60] 0 0
Poland
State/province [60] 0 0
Rzeszow
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Girona
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Oviedo
Country [65] 0 0
Spain
State/province [65] 0 0
Santander
Country [66] 0 0
Spain
State/province [66] 0 0
Sevilla
Country [67] 0 0
Spain
State/province [67] 0 0
Valencia
Country [68] 0 0
Thailand
State/province [68] 0 0
Bangkok
Country [69] 0 0
Thailand
State/province [69] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Exelixis
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05678673
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Exelixis Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1-888-EXELIXIS (888-393-5494)
Fax 0 0
Email 0 0
druginfo@exelixis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05678673