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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	09.07.2018

Trial locations

Investigated drugs:

Durvalumab

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.

Investigated diseases:

Neoplasm malignant

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.

Trial ID:

2024-518151-29-00

Protocol code:

UC-0101/1709

NCT ID:

NCT03518606

Trial Phase:

Phase II and Phase III (Integrated)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?