A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum
This study is investigating a new treatment approach for people with advanced bowel cancer (colon or rectal cancer) that has spread or cannot be removed by surgery. Researchers are testing a new drug called VVD-133214 alongside an existing immunotherapy, pembrolizumab. The new drug aims to stop cancer cells with a specific genetic fault from growing, while pembrolizumab helps the body's immune system fight the cancer. The study wants to find the best dose of VVD-133214 when given with pembrolizumab, and to see if this combination works better than pembrolizumab on its own. Participants will have regular check-ups to monitor their health and the cancer's response.
At a glance
What is this study about?
Many people with advanced bowel cancer need new and more effective treatment options. Current treatments like surgery, chemotherapy, radiotherapy, and immunotherapy can be helpful, but they don't work for everyone, might cause side effects, or can stop working over time. This study is exploring a new combination of medicines to see if it can offer a better way to fight this type of cancer, especially when it has spread to other parts of the body.
Our bodies' cells normally fix themselves when mistakes happen in their DNA. However, in some bowel cancers, this repair system doesn't work properly. This is known as dMMR (which stands for 'deficient mismatch repair') or MSI ('microsatellite instability'). When this happens, cancer cells rely more on a specific protein, called Werner helicase, to survive. The study drug, VVD-133214, is designed to block this Werner helicase protein. By doing this, it might stop these specific cancer cells from growing, while having less impact on healthy cells.
VVD-133214 is being tested alongside pembrolizumab, which is an approved immunotherapy. Immunotherapies work by boosting your own immune system to recognise and attack cancer cells. This study aims to find the safest and most effective dose of VVD-133214 when given with pembrolizumab. It also wants to compare how well this new combination works against pembrolizumab by itself, in people with advanced bowel cancer who have these specific dMMR/MSI features and haven't had previous treatment for their advanced disease.
Key takeaways
- This study explores a new combination treatment for advanced bowel cancer.
- It targets specific bowel cancers with dMMR/MSI genetic features.
- The new drug, VVD-133214, is combined with the immunotherapy pembrolizumab.
- The aim is to find the best dose and see if the combination works better than pembrolizumab alone.
- Participants will receive close medical monitoring and can withdraw at any time.
Who may be eligible?
To be considered for this study, you would typically need to meet certain requirements. You must have advanced bowel cancer (cancer of the colon or rectum) that has spread or can't be removed by surgery. Your cancer also needs to show specific genetic features called MSI or dMMR, which means your cells have trouble repairing their DNA. This would have been confirmed by a previous test. You should also not have received any prior treatment specifically for your advanced bowel cancer.
There are also some other important health checks. You should generally be well enough to take part in a study like this, as assessed by your doctor. You would need to provide a sample of your tumour tissue that was collected previously, so the researchers can do some extra tests. Also, if you are a woman who could become pregnant, you would need to have a negative pregnancy test before starting treatment.
However, you wouldn't be able to join if you've already had immunotherapy (like anti-PD-1 or anti-CTLA-4 drugs) in the past, even if it was given after surgery. You also can't take part if your cancer has spread to your brain and is causing ongoing problems or needs continuous medication. Certain autoimmune conditions (where your immune system attacks your own body) would also prevent you from joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do you have advanced bowel cancer that has spread or can't be surgically removed?
- Has your cancer been tested and confirmed to have 'MSI' or 'dMMR' features?
- Have you NOT yet received any treatment for your advanced bowel cancer?
- Are you generally well and able to manage daily activities without much difficulty?
- Have you NOT had previous immunotherapy for cancer (e.g., anti-PD-1 or anti-CTLA-4 drugs)?
What does participation involve?
If you join this study, you will receive treatment with VVD-133214 and pembrolizumab. The VVD-133214 will be given for as long as it helps you and you tolerate it well. Pembrolizumab will usually be given for up to two years. You can decide to stop treatment at any time.
Throughout the study, you will have regular visits with the study doctor. These visits will involve various tests, scans, and check-ups to monitor your general health, see how the cancer is responding to the treatment, and check for any side effects. All new or worsening medical problems will be carefully recorded to ensure your safety.
After you stop receiving the study treatments, you'll have follow-up visits. The first few will be around a month after your last dose of VVD-133214, and about three months after your last pembrolizumab dose. After that, you'll have long-term follow-up visits every three months, for as long as you agree to continue taking part.
Potential risks and benefits
Locations (122)
- University of Arizona Cancer Center - North CampusVerified postcodeTucson, United States· Not yet recruiting
- University of Michigan Rogel Cancer CenterVerified postcodeAnn Arbor, United States· Not yet recruiting
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - DetroitVerified postcodeDetroit, United States· Not yet recruiting
- Mary Babb Randolph Cancer CenterVerified postcodeMorgantown, United States· Not yet recruiting
- Hospital Italiano de Buenos AiresUnverifiedBuenos Aires, Argentina· Not yet recruiting
- Centro Medico FleischerUnverifiedBuenos Aires, Argentina· Not yet recruiting
- Instituto Alexander FlemingUnverifiedBuenos Aires, Argentina· Not yet recruiting
- Sanatorio Allende | Departamento de Investigación ClínicaVerified postcodeCórdoba, Argentina· Not yet recruiting
- Fundación IntecnusVerified postcodeBariloche, Argentina· Not yet recruiting
- Sanatorio Parque - OncologyVerified postcodeRosario, Argentina· Not yet recruiting
- Investigaciones Oncológicas C ColónUnverifiedMar Del Plata, Buenos Aires,, Argentina· Not yet recruiting
- Institut Jules Bordet - Clinique D'OncologyVerified postcodeBrussels, Belgium· Not yet recruiting
Common questions
What type of cancer is this study for?
This study is for people with advanced bowel cancer (cancer of the colon or rectum) that has spread or can't be removed by surgery.
What are MSI and dMMR?
These are genetic features in some cancer cells, meaning they have trouble fixing their DNA. This study focuses on cancers with these specific features.
What are the treatments being tested?
The study tests a new drug, VVD-133214, combined with an existing immunotherapy called pembrolizumab.
How long will I be on the treatment?
VVD-133214 is given for as long as it helps and is tolerated. Pembrolizumab is typically given for up to two years. You can stop treatment anytime.
Will I get the new drug, or pembrolizumab alone?
The study is comparing the combination of VVD-133214 plus pembrolizumab against pembrolizumab alone, so you would receive one of these two options.
How to find out more
Bayer Clinical Trials Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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