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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05425940




Registration number
NCT05425940
Ethics application status
Date submitted
16/06/2022
Date registered
21/06/2022

Titles & IDs
Public title
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
Scientific title
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
Secondary ID [1] 0 0
2021-003243-21
Secondary ID [2] 0 0
XL092-303
Universal Trial Number (UTN)
Trial acronym
STELLAR-303
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XL092
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Regorafenib

Experimental: Experimental Arm - Subjects with mCRC will receive XL092 + atezolizumab

Active comparator: Control Arm - Subjects with mCRC will receive active comparator of regorafenib


Treatment: Drugs: XL092
Supplied as tablets; administered orally daily

Treatment: Drugs: Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once in a 3-week cycle (q3w)

Treatment: Drugs: Regorafenib
Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Approximately 32 months after the first subject is randomized.
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Approximately 32 months after the first subject is randomized.

Eligibility
Key inclusion criteria
* Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.

* Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
* Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
* Has received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.

* Systemic SOC anticancer therapy if approved and available in the country where the subject is randomized.
* Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen.
* Measurable disease according to RECIST v1.1 as determined by the Investigator.
* Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
* Recovery to baseline or = Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
* Age 18 years or older on the day of consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate organ and marrow function.
* Fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment.
* 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
* Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
* Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
* Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.
* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.
* Subject has uncontrolled, significant intercurrent or recent illness.
* Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
* Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
* Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
* Pregnant or lactating females.
* Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
* Previously identified allergy or hypersensitivity to components of the study treatment formulations.
* Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
* Administration of a live, attenuated vaccine within 30 days 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
874
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Exelixis Clinical Site #83 - Albury
Recruitment hospital [2] 0 0
Exelixis Clinical Site #53 - Bankstown
Recruitment hospital [3] 0 0
Exelixis Clinical Site #117 - Bedford Park
Recruitment hospital [4] 0 0
Exelixis Clinical Site #97 - Heidelberg
Recruitment hospital [5] 0 0
Exelixis Clinical Site #19 - Melbourne
Recruitment hospital [6] 0 0
Exelixis Clinical Site #23 - Melbourne
Recruitment hospital [7] 0 0
Exelixis Clinical Site #27 - Port Macquarie
Recruitment hospital [8] 0 0
Exelixis Clinical Site #64 - Woodville South
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
3021 - Melbourne
Recruitment postcode(s) [7] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [8] 0 0
5011 - Woodville South
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Indiana
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Kentucky
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Missouri
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Nebraska
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North Carolina
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Oregon
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Pennsylvania
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Tennessee
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Washington
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Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Namur
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France
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Besançon
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France
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Dijon
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Herbault
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Lyon
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France
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Marseille
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Paris
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France
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Suresnes
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Germany
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Germany
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Germany
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Gyor
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Opole
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Siedlce
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Tomaszów Mazowiecki
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Almada
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Coimbra
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Guimarães
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Lisboa
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Singapore
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Singapore
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Spain
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Barcelona
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Lleida
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Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Taiwan
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Guishan
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Taiwan
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Kaohsiung
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Taiwan
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Liuying
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Taichung
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Taiwan
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Tainan
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Thailand
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Chiang Mai
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Thailand
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Hat Yai
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United Kingdom
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England
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Birmingham
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Edinburgh
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London
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Romford
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United Kingdom
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Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05425940