Not recruiting

Study of Nous-209 Genetic Vaccine and Pembrolizumab for Patients with Advanced Microsatellite Instability-High Colorectal Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The study is testing a new treatment approach using a genetic vaccine called Nous-209, which includes two investigational products: GAd20-209-FSP and MVA-209-FSP. These products are designed to help the immune system recognize and fight cancer cells. Additionally, the study involves the use of pembrolizumab, a medication that helps the immune system attack cancer cells more effectively.

The purpose of this study is to explore the potential benefits of combining the genetic vaccine with pembrolizumab in treating patients with MSI-H or dMMR colorectal cancer. Participants in the study will receive the investigational vaccine and pembrolizumab, or a placebo, to compare the effects. The study will monitor the participants over a period of time to assess the treatment's impact on the cancer.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to evaluate the treatment's effectiveness. The study aims to gather information on how well the combination of the genetic vaccine and pembrolizumab works in shrinking or controlling the cancer, as well as to observe any side effects that may occur. This research could provide valuable insights into new treatment options for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide written consent to participate.
The patient will undergo initial assessments to confirm eligibility, including tests to verify the presence of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status.
Step 2
Treatment initiation
The treatment involves a combination of a genetic vaccine and a medication called pembrolizumab.
The genetic vaccine consists of two components: GAd20-209-FSP and MVA-209-FSP, both administered as a solution for injection into the muscle.
Pembrolizumab is given as a solution for infusion into a vein.
Step 3
Treatment schedule
The patient will receive the GAd20-209-FSP and MVA-209-FSP injections according to a schedule determined by the study team.
Pembrolizumab will be administered every three weeks, with the dosage and duration specified by the study protocol.
Step 4
Monitoring and assessments
Regular monitoring will occur to assess the patient's response to the treatment and to check for any side effects.
Assessments will include imaging tests to evaluate tumor response, following the RECIST criteria, which is a standard way to measure how well a tumor responds to treatment.
Step 5
Follow-up
After completing the treatment, the patient will continue to be monitored for any long-term effects and overall health status.
Follow-up visits will be scheduled at intervals specified by the study team to ensure ongoing safety and to gather additional data on the treatment's effectiveness.

Who can join the trial?

15 criteria

Must be able to understand and willing to sign a written agreement to participate in the study.
Must have a life expectancy of at least 6 months.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status, which is a scale used to assess how a disease affects a patient's daily living abilities.
Must have recovered from any side effects of previous chemotherapy to a mild level (except hair loss). If major surgery or radiation therapy was received, recovery from any side effects or complications is required.
Must have adequate organ function and appropriate blood values as defined in the study's guidelines. If initial tests show values outside the required range, retesting may be done to ensure they meet the criteria.
For Cohort C (Phase II): Must not have been previously treated with certain types of cancer drugs known as anti-PD-1 or anti-PD-L1 checkpoint inhibitors.
For Cohort D (Phase IIb): May have experienced disease progression after receiving approved therapy.
If participating in additional research, must agree to have a biopsy taken from a tumor that can be safely biopsied. An older biopsy sample (not older than 6 months) from a non-radiated area can be used. Optionally, agree to another biopsy during treatment if it is safe and possible.
Must have measurable disease according to RECIST version 1.1, which is a set of guidelines for measuring cancer response to treatment.
Patients with another cancer that does not interfere with the study's safety or effectiveness can participate.
Females must not be pregnant or breastfeeding and must either not be able to have children or agree to use effective birth control methods during the study and for 180 days after the last treatment. They must also refrain from donating eggs during this period.
Fertile male patients must agree to use birth control during the study and for 180 days after the last treatment and refrain from donating sperm during this period.
Must have previously confirmed microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status, which are specific characteristics of certain cancers. Testing for these characteristics should be done locally using certified methods.
For Cohort C (Phase II): Must have locally advanced cancer that cannot be surgically removed or has spread, with MSI-H or dMMR characteristics, and be eligible for a specific type of cancer treatment. Previous chemotherapy is allowed if completed at least 6 months before the study starts. For Cohort D (Phase IIb): Must have similar cancer characteristics and have shown disease progression after a stable or better response to previous treatment.
Must be 18 years of age or older on the day of signing the consent form.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Nous-209 Genetic Vaccine
is a new type of vaccine being studied for its potential to treat certain types of cancer, specifically those with microsatellite instability. This vaccine is designed to help the body's immune system recognize and attack cancer cells more effectively.
Pembrolizumab
is a medication that helps the immune system fight cancer. It works by blocking a specific protein on cancer cells, making it easier for the immune system to detect and destroy them. This medication is often used in combination with other treatments to enhance its effectiveness.

Pembrolizumab

What is already known about the treatment

Nous-209 Genetic Vaccine – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer. It is specifically being tested for use in patients with locally advanced unresectable or metastatic colorectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR). The vaccine works by targeting specific genetic mutations found in these cancer cells, aiming to stimulate the immune system to attack the tumor. It falls under the category of cancer vaccines, which are designed to help the body recognize and fight cancer cells.

Investigated diseases

Colorectal Cancer (CRC) – Colorectal cancer is a type of cancer that starts in the colon or rectum, parts of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. When the cancer is locally advanced and unresectable, it means it has spread to nearby tissues but cannot be removed with surgery. If it is metastatic, the cancer has spread to other parts of the body. Microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) are specific genetic features of some colorectal cancers that can affect how the disease progresses.