Status:
ACTIVE_NOT_RECRUITING
Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
Lead Sponsor:
Exelixis
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal c...
Eligibility Criteria
Inclusion
- Key
- Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Documented rat sarcoma (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 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 participant 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 Response Evaluation Criteria in Solid Tumors (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 (common terminology criteria for adverse events \[CTCAE\] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ and marrow function.
- Fertile participants 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.
- Females of childbearing potential must not be pregnant at screening.
- Key
Exclusion
- Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (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.
- Has uncontrolled, significant intercurrent or recent illness.
- Major surgery (example, gastrointestinal (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 milliseconds (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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
901 Patients enrolled
Trial Details
Trial ID
NCT05425940
Start Date
September 7 2022
End Date
January 1 2027
Last Update
October 23 2025
Active Locations (133)
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1
Exelixis Clinical Site #65
Jonesboro, Alabama, United States, 72401
2
Exelixis Clinical Site #30
Phoenix, Arizona, United States, 85004
3
Exelixis Clinical Site #70
Tucson, Arizona, United States, 85719
4
Exelixis Clinical Site #9
Duarte, California, United States, 91010