In short
A groundbreaking clinical trial is underway to evaluate the effectiveness of Mva-209-Fsp-B2, a component of the Nous-209 genetic vaccine, in treating advanced colorectal cancer. This innovative approach combines the vaccine with pembrolizumab, an immunotherapy drug, to target microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. The study aims to assess the safety, tolerability, and potential anti-tumor activity of this combination therapy in patients with locally advanced unresectable or metastatic colorectal cancer.
At a glance
- Study Type
- Phase I/II, Multicenter, Open-Label
- Main Intervention
- Nous-209 Genetic Vaccine (including Mva-209-Fsp-B2) + Pembrolizumab
- Target Condition
- Advanced MSI-H/dMMR Colorectal Cancer
- Primary Endpoint
- Overall Response Rate (ORR) by RECIST v1.1
- Secondary Endpoints
- Safety, Tolerability, Best Overall Response, Duration of Response, Progression-Free Survival
- Key Eligibility Criteria
- Age ≥18, ECOG 0-1, Adequate Organ Function, Measurable Disease
- Exclusion Criteria
- Immunodeficiency, Active Severe Infections, Untreated HBV/HCV, Active CNS Metastases
- Administration Route
- Intramuscular Injection (for Mva-209-Fsp-B2)
What is MVA-209-FSP?
MVA-209-FSP is an investigational genetic vaccine being developed for the treatment of certain types of cancer. It is also known by the name "Nous-209" and is classified as a solution for injection. This innovative treatment is currently being studied in clinical trials to evaluate its effectiveness and safety.
How does MVA-209-FSP work?
MVA-209-FSP is a complex vaccine composed of four different vectors (MVA-209-FSP-B1, MVA-209-FSP-B2, MVA-209-FSP-B3, and MVA-FSP-B4). These vectors are based on a modified form of the vaccinia virus called Modified Vaccinia Ankara (MVA). Each vector carries genetic information that encodes for 209 Frame Shift Peptides (FSPs).
Frame Shift Peptides are unique proteins that can be produced in certain types of cancer cells due to genetic errors. By introducing these FSPs into the body, the vaccine aims to stimulate the immune system to recognize and attack cancer cells that produce these abnormal proteins.
What conditions does MVA-209-FSP target?
MVA-209-FSP is being developed to treat microsatellite unstable solid tumors. Specifically, the current clinical trial is focusing on patients with:
- Locally advanced unresectable or metastatic colorectal cancer (CRC) that is:
- Microsatellite instability-high (MSI-H), or
- Mismatch repair deficient (dMMR)
These terms may sound complex, so let's break them down:
- Locally advanced unresectable: The cancer has spread from where it started to nearby tissue or lymph nodes and cannot be completely removed with surgery.
- Metastatic: The cancer has spread to other parts of the body.
- Microsatellite instability-high (MSI-H): This refers to a characteristic of the tumor where there are many errors in certain areas of the DNA called microsatellites.
- Mismatch repair deficient (dMMR): This means the tumor has problems with a normal process that fixes mistakes in DNA when cells divide.
Current Clinical Trial
MVA-209-FSP is currently being studied in a Phase I/II clinical trial. This trial is designed to evaluate both the safety and effectiveness of the vaccine when combined with another drug called pembrolizumab. The main goals of the trial include:
- Assessing the safety and tolerability of the treatment combination
- Measuring how well the tumors respond to the treatment (called the Overall Response Rate or ORR)
- Determining how long the treatment effects last (Duration of Response or DoR)
- Evaluating how long patients live without their cancer getting worse (Progression-Free Survival or PFS)
Who is eligible for the trial?
The trial is open to adults (18 years or older) with specific types of colorectal cancer. Some key eligibility criteria include:
- Having locally advanced unresectable or metastatic colorectal cancer that is MSI-H or dMMR
- Having a life expectancy of at least 6 months
- Being in relatively good overall health (ECOG Performance Status of 0 or 1)
- Having measurable disease according to specific criteria (RECIST version 1.1)
- Not having received certain previous treatments (depending on which part of the trial they're entering)
Safety Considerations
As with any clinical trial, there are important safety considerations. Some patients may not be eligible if they have:
- Certain active infections or a weakened immune system
- Active brain metastases
- A history of certain lung conditions
- Recently received live virus vaccines
- Certain other medical conditions that might interfere with the study
It's important to note that this is an investigational treatment, and its full safety profile is still being studied. Patients considering participating in the trial should discuss all potential risks and benefits with their healthcare provider.