Active, not recruiting
Phase 3
Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
Condition(s) studied
Colorectal Cancer
Investigational drug(s) / intervention(s)
XL092: Supplied as tablets; administered orally daily.
Atezolizumab: Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).
Regorafenib: Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.
Study 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 cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.
Eligibility
Key Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
- Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants — Up to 32 months
- Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants — Up to 32 months
Trial sites (133)
| Facility | City | Region | Status |
| Exelixis Clinical Site #65 |
Jonesboro |
Alabama |
|
| Exelixis Clinical Site #30 |
Phoenix |
Arizona |
|
| Exelixis Clinical Site #70 |
Tucson |
Arizona |
|
| Exelixis Clinical Site #9 |
Duarte |
California |
|
| Exelixis Clinical Site #55 |
La Jolla |
California |
|
| Exelixis Clinical Site #77 |
Los Angeles |
California |
|
| Exelixis Clinical Site #105 |
Orange |
California |
|
| Exelixis Clinical Site #80 |
Santa Monica |
California |
|
| Exelixis Clinical Site #5 |
Santa Rosa |
California |
|
| Exelixis Clinical Site #82 |
Sylmar |
California |
|
| Exelixis Clinical Site #58 |
Torrance |
California |
|
| Exelixis Clinical Site #81 |
Whittier |
California |
|
| Exelixis Clinical Site #125 |
New Haven |
Connecticut |
|
| Exelixis Clinical Site #16 |
Miami Beach |
Florida |
|
| Exelixis Clinical Site #60 |
Orlando |
Florida |
|
| Exelixis Clinical Site #4 |
Marietta |
Georgia |
|
| Exelixis Clinical Site #3 |
Joliet |
Illinois |
|
| Exelixis Clinical Site #102 |
Indianapolis |
Indiana |
|
| Exelixis Clinical Site #10 |
Westwood |
Kansas |
|
| Exelixis Clinical Site #47 |
Lexington |
Kentucky |
|
| Exelixis Clinical Site #7 |
New Orleans |
Louisiana |
|
| Exelixis Clinical Site #22 |
St Louis |
Missouri |
|
| Exelixis Clinical Site #8 |
Billings |
Montana |
|
| Exelixis Clinical Site #1 |
Omaha |
Nebraska |
|
| Exelixis Clinical Site #15 |
Albuquerque |
New Mexico |
|
| Exelixis Clinical Site #11 |
New York |
New York |
|
| Exelixis Clinical Site #59 |
New York |
New York |
|
| Exelixis Clinical Site #17 |
The Bronx |
New York |
|
| Exelixis Clinical Site #74 |
Charlotte |
North Carolina |
|
| Exelixis Clinical Site #6 |
Cincinnati |
Ohio |
|
| Exelixis Clinical Site #12 |
Oklahoma City |
Oklahoma |
|
| Exelixis Clinical Site #75 |
Portland |
Oregon |
|
| Exelixis Clinical Site #106 |
Philadelphia |
Pennsylvania |
|
| Exelixis Clinical Site #18 |
Pittsburgh |
Pennsylvania |
|
| Exelixis Clinical Site #103 |
Pittsburgh |
Pennsylvania |
|
| Exelixis Clinical Site #24 |
Greenville |
South Carolina |
|
| Exelixis Clinical Site #56 |
Chattanooga |
Tennessee |
|
| Exelixis Clinical Site #76 |
Nashville |
Tennessee |
|
| Exelixis Clinical Site #133 |
Nashville |
Tennessee |
|
| Exelixis Clinical Site #450 |
Fairfax |
Virginia |
|
+ 93 more sites — see the full list on the official registry below.
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