Recruiting nowPhase 3Randomised
| Registry number | NCT07284849 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, blinded |
| Taking part | 700 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Incyte Corporation |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug INCA33890
- Drug Placebo
- Drug Bevacizumab
- Drug FOLFOX
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.
What this trial is trying to do
The trial asks whether adding INCA33890 to standard first-line chemotherapy (FOLFOX) and bevacizumab can control metastatic microsatellite-stable colorectal cancer better than chemotherapy and bevacizumab alone. The available description does not state how INCA33890 is intended to work.
Researchers will compare the combination with standard treatment plus placebo, looking mainly at whether it delays cancer growth, measured as progression-free survival, while also assessing safety. It will also measure whether adding INCA33890 causes more or fewer side effects than standard treatment alone.
Worth knowing: This is restricted to metastatic microsatellite-stable colorectal cancer, and its main measure is time before the cancer grows rather than how long people live overall.
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 purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.
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
Inclusion Criteria
- Stage IV colorectal adenocarcinoma not amenable to curative resection.
- No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
- Measurable disease per RECIST v1.1.
- ECOG performance status of 0 or 1.
- Adequate organ function determined by laboratory results.
Exclusion Criteria
- MSI-H/dMMR per historical data in the medical record.
- BRAF V600E mutation per historical data in the medical record.
- Untreated and/or progressing CNS metastases.
- History of other malignancy within 2 years.
- Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Significant concurrent and/or uncontrolled medical condition.
- History of organ transplant, including allogeneic stem cell transplantation.
Other protocol-defined inclusion/exclusion criteria apply.
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 254 sites. Listed in: Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Georgia, Germany, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, Switzerland, 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 NCT07284849, registered by Incyte Corporation 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.