Not recruiting

Study of Metronomic Oral Vinorelbine with Durvalumab and Tremelimumab for Patients with Advanced Solid Tumors

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 forms of solid tumors, which include cancers such as head and neck cancer, prostate cancer, cervical cancer, and breast cancer. The study also includes other types of cancers that have a high number of genetic changes or are characterized by a condition known as microsatellite instability. The treatment being tested is a combination of a chemotherapy drug called metronomic oral vinorelbine and two immunotherapy drugs, durvalumab (also known by its code name MEDI4736) and tremelimumab. These drugs are designed to help the immune system fight cancer more effectively.

The purpose of the study is to find the best dose of the chemotherapy drug when used with the immunotherapy drugs and to see how well this combination works in treating the cancers mentioned. The study will be conducted in two phases. In the first phase, researchers will determine the safest and most effective dose of the chemotherapy drug. In the second phase, they will evaluate how well the combination of treatments works in controlling the cancer. Participants will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream.

Throughout the study, participants will be closely monitored for any side effects and the effectiveness of the treatment. The study aims to provide valuable information on whether this combination of chemotherapy and immunotherapy can offer benefits to patients with advanced solid tumors. Participants will have regular check-ups and tests to track their progress and the impact of the treatment on their cancer. The study is expected to continue until the end of 2025.

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, a written informed consent form must be signed. This confirms understanding and agreement to participate in the study.
A baseline tumor biopsy is required unless a recent biopsy is available. Blood samples will be collected throughout the study.
Step 2
Initial assessments
Initial assessments include checking normal heart function, kidney function, and liver function. These are necessary to ensure eligibility for the study.
A pregnancy test is required for women of childbearing potential to confirm non-pregnancy status.
Step 3
Treatment phase
The treatment involves a combination of medications: metronomic oral vinorelbine, durvalumab, and tremelimumab. These are used to treat advanced solid tumors.
Durvalumab is administered as an intravenous infusion. The dosage and frequency will be determined during the study.
The treatment phase includes regular visits to monitor health and response to the medications.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring for any side effects or adverse reactions is conducted. This ensures safety and helps adjust treatment if necessary.
Follow-up visits are scheduled to assess the effectiveness of the treatment and to monitor overall health.
Step 5
End of study
At the end of the study, a final assessment is conducted to evaluate the overall response to the treatment.
Participants may be asked to provide feedback on their experience during the study.

Who can join the trial?

15 criteria

The patient must have signed a written informed consent form before any study-specific procedures.
The patient must have a normal heart function, with a left ventricular ejection fraction (LVEF) of 50% or higher. LVEF is a measure of how well the heart pumps blood.
The patient must have a creatinine clearance of 40 mL/min or higher, or creatinine levels 1.5 times the upper limit of normal (ULN) or lower. Creatinine clearance is a test to check kidney function.
For female patients who are pre-menopausal, there must be evidence of post-menopausal status or a negative pregnancy test (urine test within 72 hours or serum test within 14 days before joining the study).
The patient must be willing and able to follow the study protocol, including treatment, scheduled visits during the treatment phase, and follow-up visits.
The patient must agree to a baseline tumor biopsy unless a recent biopsy is available. A biopsy is a procedure to remove a small sample of tissue for testing.
The patient must be affiliated with a social health insurance.
The patient must have locally advanced or metastatic solid tumors that are resistant to standard treatments and are candidates for experimental therapy. This includes specific types of cancer such as head and neck, breast, prostate, and cervical cancers, as well as other tumors with high mutational load or microsatellite instability (MSI).
The patient must be 18 years or older at the time of registration.
The patient must have a life expectancy of 3 months or more.
The patient must have measurable disease according to RECIST v1.1, which is a set of guidelines to measure how well a tumor responds to treatment.
The patient must have an ECOG performance status of 1 or lower. This is a scale to assess how a patient's disease affects their daily living abilities.
The patient must weigh more than 30 kg (about 66 pounds).
The patient must have normal blood function, with specific levels of white blood cells, platelets, and hemoglobin.
The patient must have normal liver function, with specific levels of bilirubin, ASAT, and ALAT. These are tests to check how well the liver is working.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than those specified in the study.
Patients who have not reached the required age range for the study.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer treatment recently that might interfere with the study.
Patients who have allergies to the study medications or their ingredients.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of certain immune system disorders.
Patients who have active infections that require treatment.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Metronomic Oral Vinorelbine
is a type of chemotherapy medication used to treat cancer. In this trial, it is given in a way that involves taking small, regular doses over a long period. This approach aims to slow down the growth of cancer cells and reduce side effects compared to traditional chemotherapy, which is often given in higher doses with breaks in between.
Durvalumab
is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a protein called PD-L1, which is found on some cancer cells. By blocking this protein, durvalumab helps the immune system recognize and attack cancer cells more effectively.
Tremelimumab
is another immunotherapy drug used in this trial. It works by targeting a protein called CTLA-4, which is found on certain immune cells. By blocking this protein, tremelimumab helps activate the immune system to attack cancer cells. When used together with durvalumab, it aims to enhance the overall immune response against cancer.

Durvalumab

What is already known about the treatment

Metronomic Oral Vinorelbine
This medication is taken by mouth and is currently being studied in combination with other drugs for treating advanced solid tumors, such as those in the head and neck, prostate, cervix, and breast. It is in the early stages of clinical trials to determine the best dose and to see how well it works when used with immunotherapy drugs. The main goal is to slow down or stop the growth of cancer cells. It belongs to a group of drugs known as chemotherapy agents, which work by interfering with the division of cancer cells.
Durvalumab
Administered as an infusion into a vein, this medication is part of a class of drugs called immune checkpoint inhibitors. It is being tested in combination with other treatments for advanced solid tumors. Durvalumab works by helping the immune system recognize and attack cancer cells more effectively. It is currently being evaluated in clinical trials to assess its effectiveness and safety in combination with other therapies.
Tremelimumab
This medication is given through an infusion into a vein and is also an immune checkpoint inhibitor. It is being studied alongside other drugs to treat advanced solid tumors. Tremelimumab helps the immune system target and destroy cancer cells by blocking certain proteins that prevent immune responses. It is in clinical trials to determine its potential benefits and optimal use in combination with other cancer treatments.

Investigated diseases

Head and Neck Cancer
This disease involves malignant tumors that develop in or around the throat, larynx, nose, sinuses, and mouth. It often begins in the squamous cells lining these areas. As it progresses, it can cause symptoms like a persistent sore throat, difficulty swallowing, and changes in voice. The cancer may spread to nearby lymph nodes and tissues. Advanced stages can lead to more severe symptoms and complications.
Prostate Cancer
This disease occurs when cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, and erectile dysfunction. The cancer can spread to bones and other organs. Monitoring its progression is crucial for managing symptoms and complications.
Cervical Cancer
This disease starts in the cells of the cervix, the lower part of the uterus. It typically progresses from pre-cancerous changes to invasive cancer over several years. Early stages may not present symptoms, but advanced stages can cause abnormal bleeding, pelvic pain, and discharge. The cancer can spread to nearby tissues and organs. Regular monitoring is important to track its progression.
Breast Cancer
This disease involves the uncontrolled growth of cells in the breast tissue. It can begin in different parts of the breast, such as ducts or lobules. As it progresses, it may cause a lump, changes in breast shape, or skin dimpling. The cancer can spread to lymph nodes and other body parts. Early detection is key to managing its progression.
Miscellaneous Malignancies with High Mutational Load and/or MSI-High
These are various types of cancers characterized by a high number of genetic mutations or microsatellite instability. They can occur in different organs and tissues. The progression varies depending on the specific type and location of the cancer. Symptoms and complications depend on the affected area. Monitoring is essential to understand the disease's behavior and impact.