Trials / Active Not Recruiting
Active Not RecruitingNCT05425940
Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 901 (actual)
- Sponsor
- Exelixis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XL092 | Supplied as tablets; administered orally daily. |
| DRUG | 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). |
| DRUG | Regorafenib | Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle. |
Timeline
- Start date
- 2022-09-07
- Primary completion
- 2026-05-01
- Completion
- 2027-01-01
- First posted
- 2022-06-21
- Last updated
- 2025-10-23
Locations
133 sites across 16 countries: United States, Australia, Belgium, France, Germany, Hong Kong, Hungary, New Zealand, Poland, Portugal, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05425940. Inclusion in this directory is not an endorsement.