Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Researchers are investigating a new ‘genetic vaccine’ called Nous-209, given with an established cancer medication, Keytruda® (pembrolizumab). This treatment is for adults with advanced colorectal, stomach, or gastro-oesophageal junction cancers that have a specific genetic marker (MSI-H or dMMR). The study is in two main stages: Phase 1 focuses on finding a safe dose and understanding potential side effects, as well as how the body’s immune system responds. Phase 2 will then look more closely at whether the treatment effectively shrinks tumours. The vaccine is given as a jab, with an initial 'prime' dose followed by several 'boost' doses, all alongside regular Keytruda® infusions. This research hopes to find new ways to help patients with these types of cancer.
At a glance
What is this study about?
This clinical trial is exploring a new treatment approach for specific types of advanced cancers: colorectal (bowel), gastric (stomach), and cancers where the food pipe meets the stomach (gastro-oesophageal junction). These cancers must have a particular genetic feature known as 'microsatellite instability-high' (MSI-H) or 'mismatch repair deficient' (dMMR). This genetic feature often means these cancers respond well to certain immune-boosting treatments.
The new treatment being tested is a 'genetic vaccine' called Nous-209, which is given in combination with an existing cancer drug called Keytruda® (pembrolizumab). Keytruda® is an immunotherapy that works by helping your body's immune system recognise and fight cancer cells. The Nous-209 vaccine is designed to further boost this immune response, specifically targeting the cancer in a new way. The idea is that combining these two treatments might be more effective than Keytruda® alone.
The study is split into two parts: Phase 1 and Phase 2. Phase 1 is mainly about safety: finding the right dose of the Nous-209 vaccine that causes the fewest side effects when given with Keytruda®, and observing how the body's immune system reacts to it. Once a safe dose is found, Phase 2 will then focus on whether this combined treatment is effective at shrinking tumours or slowing down their growth. This research is important because it could lead to new treatment options for people living with these specific advanced cancers.
Key takeaways
- Tests a new 'genetic vaccine' (Nous-209) with an existing cancer drug (Keytruda®).
- For adults with advanced colorectal, stomach, or gastro-oesophageal junction cancers with specific genetic markers (MSI-H/dMMR).
- Phase 1 looks at safety and dosage, Phase 2 at effectiveness.
- Treatment involves injections for the vaccine and infusions for Keytruda®.
- Requires regular hospital visits and follow-up over several months to years.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or over.
Your cancer needs to be advanced, meaning it cannot be removed by surgery or has spread. It must also have a specific genetic marker called MSI-H or dMMR. You can't have had previous treatment with similar immune-boosting drugs like Keytruda®. You should generally feel well enough to participate, have a life expectancy of at least 6 months, and your body's organs (like your liver and kidneys) need to be working adequately.
There are other specific health requirements that the doctors will check to make sure the study is safe for you. If you've had recent major surgery, radiation, or chemotherapy, you'll need to have recovered from those treatments.
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.
- Are you 18 years old or older?
- Do you have advanced colorectal, stomach, or gastro-oesophageal junction cancer?
- Has your cancer been tested for MSI-H or dMMR and shown to have this marker?
- Have you NOT received previous treatment with similar immune-boosting drugs like Keytruda®?
- Are you generally well enough to participate in a clinical study?
What does participation involve?
If you take part in this study, you will receive the Nous-209 genetic vaccine and Keytruda® (pembrolizumab). The vaccine is given as an injection into a muscle, and Keytruda® is given as a drip (infusion). You'll have an initial 'prime' vaccine dose, followed by several 'boost' doses over a period of weeks, all alongside regular Keytruda® infusions. The timing of these doses will be carefully planned by the study doctors.
Taking part involves regular visits to the hospital for treatment, check-ups, blood tests, and scans to monitor your health and the cancer's response. The first part of the study involves visits over about 6 months, with an extended follow-up period for up to two years and three months to continue monitoring your health. The total duration of your participation will depend on which part of the study you are in and how you respond to the treatment.
Potential risks and benefits
Locations (46)
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States
- City of Hope Comprehensive Cancer CenterVerified postcodeIrvine, United States
- USC Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States
- USC Norris Comprehensive Cancer CenterVerified postcodeNewport Beach, United States
- Mt. SinaiVerified postcodeMiami Beach, United States
- Boca Raton Clinical ResearchVerified postcodePlantation, United States
- Goshen Center for Cancer CareVerified postcodeGoshen, United States
- Johns Hopkins UniversityVerified postcodeBaltimore, United States
- Washington University School of Medicine, Division of OncologyVerified postcodeSt Louis, United States
- Roswell Park Comprehensive Cancer CenterVerified postcodeBuffalo, United States
- NYU Langone Medical CenterVerified postcodeNew York, United States
- Weill Cornell Medicine / New York-Presbyterian HospitalVerified postcodeNew York, United States
Common questions
What is a 'genetic vaccine' in this context?
It's a new type of vaccine designed to teach your immune system to recognise and fight cancer cells, not to prevent an infection like a flu vaccine.
What does MSI-H or dMMR mean?
These are genetic markers in your tumour that mean it might respond well to certain immune-boosting cancer treatments.
Will I still receive Keytruda® if I don't get the vaccine?
No, this study specifically tests the combination of the Nous-209 vaccine with Keytruda®.
How long will I be involved in the study?
Participation can last for around 6 months for the main treatment phase, with extended follow-up for over two years to monitor your health.
Can I stop participating in the study if I change my mind?
Yes, you have the right to withdraw from the study at any time without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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