STELLAR-303: Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
Study Details
Study Description
Brief Summary
This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed after or are intolerant to standard-of-care (SOC) therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Arm Subjects with mCRC will receive XL092 + atezolizumab |
Drug: XL092
Supplied as tablets; administered orally daily
Drug: Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once in a 3-week cycle (q3w)
Other Names:
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| Active Comparator: Control Arm Subjects with mCRC will receive active comparator of regorafenib |
Drug: Regorafenib
Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle
Other Names:
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Outcome Measures
Primary Outcome Measures
- Duration of Overall Survival (OS) [Approximately 26 months after the first subject is randomized]
Defined as the time from randomization to death due to any cause
Other Outcome Measures
- Duration of Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1 [Approximately 26 months after the first subject is randomized]
Defined as the time randomization to the earlier of either radiographic progressive disease (PD) as assessed by the Investigator per RECIST 1.1 or death from any cause
- Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 [Up to 36 months after the first subject is randomized]
Defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) per as assessed by the Investigator RECIST 1.1 criteria
- Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1 [Up to 36 months after the first subject is randomized]
Defined as the time from the first documentation of objective response (subsequently confirmed at a visit ≥ 28 days later) to disease progression or death due to any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
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Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
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Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
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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.
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Radiographic progression during treatment with or within 3 months following the last dose of the most recent approved SOC chemotherapy regimen.
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Measurable disease according to RECIST v1.1 as determined by the Investigator.
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Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
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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.
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Age 18 years or older on the day of consent.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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Adequate organ and marrow function.
Exclusion Criteria:
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Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
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Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
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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.
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Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
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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.
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Concomitant anticoagulation with oral anticoagulants and platelet inhibitors.
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Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
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Pregnant or lactating females.
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Administration of a live, attenuated vaccine within 30 days before randomization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Exelixis Clinical Site #1 | Omaha | Nebraska | United States | 68130 |
Sponsors and Collaborators
- Exelixis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XL092-303
- 2021-003243-21