Running, not taking new patientsPhase 3Randomised
| Registry number | NCT05425940 |
|---|---|
| Recruitment | Running, not taking new patients |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 901 people (final) |
| Who can join | aged 18 Years and over |
| Run by | Exelixis |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug XL092
- Drug Atezolizumab
- Drug Regorafenib
What it is measuring
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers expect that XL092, a kinase inhibitor that blocks signals involved in tumour growth and blood-vessel formation, could work with atezolizumab, an immune drug that blocks PD-L1 and helps immune cells attack cancer. The trial is testing this combination against regorafenib in MSS/MSI-low metastatic colorectal cancer that has progressed during, after, or cannot tolerate standard treatment.
The comparison asks whether the combination helps people live longer than regorafenib, measured by overall survival. The researchers also hope that targeting the tumour and its immune protection together will improve outcomes after standard options have stopped working.
Worth knowing: The trial is limited to MSS/MSI-low metastatic colorectal cancer, so its findings may not apply to cancers with other microsatellite or mismatch-repair profiles.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 133 sites. Listed in: Australia, Belgium, France, Germany, Hong Kong, Hungary, New Zealand, Poland, Portugal, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05425940, registered by Exelixis on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.