Recruiting nowPhase 2Randomised
| Registry number | NCT06792695 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 80 people (planned) |
| Who can join | aged 18 Years to 130 Years |
| Run by | AstraZeneca |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Volrustomig
- Drug FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
- Drug Bevacizumab
What it is measuring
Progression Free Survival (PFS)
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.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a Phase II, platform, open-label, multi-drug, multicenter, global study.
This is a modular study, that includes a master protocol and substudies.
Partcipants will be randomised to one of the following intervention groups:
* Volrustomig + FOLFIRI + bevacizumab group (Arm A)
* FOLFIRI + bevacizumab group (Arm B)The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Not yet treated
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
Overall Inclusion Criteria
- Histopathologically confirmed colorectal adenocarcinoma.
- Provision of FFPE tumor sample collected as per SoC.
- Presence of measurable disease by RECIST 1.1 criteria.
- ECOG performance status of 0 or 1.
- Life expectancy ≥ 12 weeks at the time of screening.
Substudy Inclusion Criteria
- No radiological evidence of liver metastasis.
- No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, > 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.
- Known pMMR/MSS status (only pMMR/MSS mCRC allowed).
- Adequate organ and bone marrow function
- Body weight > 35 kg at screening and at randomization.
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Overall Exclusion Criteria
- Central nervous system metastases or spinal cord compression
- Known history of severe allergy to any monoclonal antibody or study intervention.
- Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.
- History of another primary malignancy.
Substudy Exclusion Criteria
- Potentially resectable disease with multidisciplinary plan for radical surgery.
- Active or prior documented autoimmune or inflammatory disorders or cardiac conditi…
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 76 sites. Listed in: Australia, Canada, China, France, Germany, Italy, Netherlands, South Korea, Spain, Taiwan, 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 NCT06792695, registered by AstraZeneca 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.