Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers think some colorectal cancers with deficient mismatch repair (dMMR) or microsatellite instability (MSI) depend on Werner helicase, a DNA-repair protein, to survive. This phase 2 trial tests whether blocking Werner helicase with VVD-133214 can add to pembrolizumab, an immunotherapy, compared with pembrolizumab alone.
The combination could work better than pembrolizumab alone if weakening the cancer’s DNA-repair capacity makes the tumour easier to control. The main comparison is the proportion of people whose cancer has not progressed at six months, while the trial also helps identify the VVD-133214 dose to use with pembrolizumab.
Worth knowing: The trial measures six-month progression-free survival rather than overall survival, and it is limited to people with MSI and/or dMMR colorectal cancer who have not yet been treated for advanced disease.
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.
| Registry number | NCT07811193 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 140 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Vividion Therapeutics, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug VVD-133214
- Drug Pembrolizumab
What it is measuring
Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
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
Researchers are looking for a better way to treat people with advanced colorectal cancer.
Colorectal cancer (cancer of the colon or rectum) is one of the most common cancers worldwide. Treatments include surgery, chemotherapy, radiotherapy, and immunotherapy; however, these treatments do not work for everyone, may cause serious adverse events or may stop working eventually. New treatments and treatment combinations are needed, especially for cancers that cannot be removed with surgery or that have spread to other parts of the body (called advanced or metastatic cancer).
Cells normally repair themselves when mistakes happen as they divide. But in some people with cancer, the repair system does not work properly because of a problem called dMMR (deficient mismatch repair). As a result, mistakes build up in the cell's DNA, leading to a condition called MSI (microsatellite instability). Over time, these changes can cause cells to grow and behave abnormally, contributing to the development and growth of cancer.
To survive, some cancer cells with dMMR or MSI rely on a protein called Werner helicase. This protein helps repair some of the DNA damage allowing them to keep growing.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- dMMR / MSI-H
- Metastatic
- Rectal
- Colon
- 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
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1
- Have a known microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) tumor status confirmed per local standard of care (SoC), and have histologically or cytologically documented advanced (unresectable and/or metastatic) colorectal adenocarcinoma (CRC)
- No prior systemic treatment for metastatic disease and not amenable to curative resection
- Participants must have documented MSI and/or dMMR tumor status determined as part of the routine diagnostic workup in a certified laboratory
- Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing including a copy of a redacted pathology report if available
- Presence of measurable disease according to RECIST v1.1
- Adequate hematologic and end-organ function, defined using laboratory results obtained within 14 days prior to first dose of study treatment
- Females of childbearing potential must have negative serum pregnancy test before starting study treatment
Exclusion Criteria
- Prior systemic treatment for advanced CRC.
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 122 sites. Listed in: Argentina, Belgium, Brazil, China, France, Germany, Greece, Hong Kong, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), 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 NCT07811193, registered by Vividion Therapeutics, Inc. 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.