Not recruiting

Study on NECVAX-NEO1 with PD-1/PD-L1 Inhibitors for Patients with Advanced Solid Tumors

Verified siteInvestigationalNo 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 advanced solid tumors, which are a type of cancer that forms in solid organs or tissues. The trial will test a new treatment called NECVAX-NEO1, which is an oral liquid medication. This treatment will be used in combination with existing therapies known as Anti-PD-1 or Anti-PD-L1 monoclonal antibody therapy. These therapies help the immune system recognize and attack cancer cells.

The purpose of the study is to assess the safety and tolerability of NECVAX-NEO1 when used alongside these existing treatments. Participants in the study will receive the new treatment and will be monitored for any side effects or changes in their health. The study will involve regular check-ups, including blood tests and scans like MRI or CT scans, to track the progress of the treatment and the condition of the tumors.

The trial will take place over several years, and participants will be closely observed to ensure their safety and to gather information on how well the treatment works. The study aims to provide valuable insights into the potential benefits of combining NECVAX-NEO1 with current cancer therapies for patients with advanced solid tumors.

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, eligibility is confirmed based on specific criteria such as age, health status, and ability to follow instructions.
Written informed consent is required, indicating understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment is conducted, including medical history review, physical examination, and laboratory tests to establish baseline health status.
Imaging tests like MRI or CT scans are performed to evaluate the tumor.
Step 3
Treatment initiation
The treatment involves the administration of NECVAX-NEO1, an oral liquid medication, in combination with a PD-1 or PD-L1 inhibitor, which are types of cancer therapies.
The dosage and frequency of NECVAX-NEO1 are determined by the study protocol and the healthcare team.
Step 4
Treatment period
Regular monitoring occurs during the treatment period, including laboratory tests, physical exams, and imaging to track the tumor's response.
Adverse events or side effects are recorded and managed by the healthcare team.
Step 5
Follow-up
After completing the treatment, follow-up visits are scheduled to monitor long-term health and any changes in the tumor.
Additional tests may be conducted to assess overall health and treatment efficacy.

Who can join the trial?

13 criteria

Patients must be able to understand and follow instructions during the trial.
Patients need to have good kidney function, which will be checked at the start of the trial.
Patients must be able to have an MRI or CT scan to check the tumor.
Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a way to measure how well a patient can perform daily activities.
Patients should have a life expectancy of at least 6 months, as judged by the doctor.
Patients must be able and willing to give written informed consent, which means they agree to participate in the study.
Both male and female patients can participate.
Patients must be at least 18 years old.
Patients should have solid tumors that can be measured, and they should be planning to receive a PD-1 or PD-L1 inhibitor as part of their standard treatment.
Patients must have a tumor or metastasis that can be accessed for a needle biopsy or surgical removal.
Patients need to have good bone marrow function, which includes having enough white blood cells, platelets, and hemoglobin. Hemoglobin is a protein in red blood cells that carries oxygen.
Patients should have an International Normalized Ratio (INR) of less than 1.5 times the normal limit. INR is a test that measures how well blood clots. Patients on certain blood thinners can have an INR of less than 3.
Patients need to have good liver function, which includes having normal levels of bilirubin, AST, and ALT. These are substances in the blood that help check how well the liver is working.

Who cannot join the trial?

3 criteria

Patients who have not been diagnosed with advanced solid tumors. Advanced solid tumors are types of cancer that have spread and formed solid masses in the body.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.

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Verified sites

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

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Responsive
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Vilnius, Lithuania

Trial locations

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Investigated drugs

NECVAX-NEO1
is a new treatment being tested in this clinical trial. It is designed to work alongside other cancer treatments to help the body's immune system fight against solid tumors. The main goal of using NECVAX-NEO1 is to see if it is safe and can be tolerated by patients when used with other therapies.
Anti-PD-1 Monoclonal Antibody Therapy
is a type of cancer treatment that helps the immune system recognize and attack cancer cells. It works by blocking a specific protein on the surface of immune cells, which can help the immune system to better target and destroy cancer cells.
Anti-PD-L1 Monoclonal Antibody Therapy
is similar to Anti-PD-1 therapy, but it targets a different protein that is often found on the surface of cancer cells. By blocking this protein, the therapy can help the immune system to identify and attack cancer cells more effectively.

Necvax-Neo1

What is already known about the treatment

NECVAX-NEO1 – This medication is administered as an injection and is currently being studied in clinical trials for its safety and tolerability when used alongside PD-1 or PD-L1 inhibitor therapy. It is primarily being investigated for the treatment of advanced solid tumors. NECVAX-NEO1 works by enhancing the immune system's ability to recognize and attack cancer cells, potentially improving the effectiveness of existing immunotherapies. It falls under the pharmacological classification of cancer immunotherapy agents.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to an advanced stage. These tumors are characterized by their ability to grow uncontrollably and invade nearby tissues. As they advance, they may spread to other parts of the body, a process known as metastasis. The progression of these tumors can vary depending on the type of cancer and its location. Symptoms often arise from the tumor pressing on nearby structures or organs, leading to pain or dysfunction. The course of the disease can be influenced by various factors, including the tumor's genetic makeup and the patient's overall health.