Title: A randomized open-label phase 3 study of XL092 + atezolizumab vs regorafenib in subjects with metastatic colorectal cancer
Responsible Party: Exelixis
Description: Researchers are conducting a phase 3 trial to compare the combination of XL092 and atezolizumab with regorafenib alone in patients with microsatellite stable/microsatellite instability-low (MSS/MSI-low) metastatic colorectal cancer (CRC).
Patients in the first arm will receive XL092 daily. XL092 is an oral tyrosine kinase inhibitor that targets VEGF receptors, MET, TAM kinases, and other kinases. Patients in the first arm will also receive 1200 mg of atezolizumab intravenously once every 3 weeks.
Patients in the second arm will receive 160 mg of regorafenib administered orally daily for the first 21 days of each 28-day cycle.
The primary outcome is overall survival. Secondary outcomes include progression-free survival, objective response rate, and the duration of response.
To be eligible for this trial, patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is MSS or MSI-low. They must have received standard anticancer therapies for metastatic CRC that has radiographically progressed or is refractory or intolerant to these therapies. For a complete list of eligibility criteria, please see the reference.
This trial is sponsored by Exelixis.
ClinicalTrials.gov. Study of XL092 + atezolizumab vs regorafenib in subjects with metastatic colorectal cancer (STELLAR-303). NCT05425940. Accessed March 23, 2023.