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Study of Intrapleural Photodynamic Therapy with Aminolevulinic Acid Hydrochloride and Nivolumab for Patients with Malignant Pleural Mesothelioma

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What is this study about?

This clinical trial is focused on studying a disease called malignant pleural mesothelioma, which is a type of cancer that affects the lining of the lungs. The study is exploring a new treatment approach that combines two therapies. The first therapy is called intrapleural photodynamic therapy, which involves using a special light to activate a drug inside the body to help kill cancer cells. This is done through a procedure called video-assisted thoracoscopy, a minimally invasive surgery that allows doctors to see inside the chest. The second therapy involves a medication called Nivolumab, also known by its code name BMS936558, which is an immunotherapy drug that helps the immune system fight cancer.

The purpose of this study is to see if this combination of treatments can be safely given to patients with malignant pleural mesothelioma. The study will involve patients receiving the photodynamic therapy first, followed by treatment with Nivolumab. The study will monitor patients to ensure that the treatments do not cause any unexpected or severe side effects. The study aims to include a small group of patients to test the feasibility of this treatment approach.

Throughout the study, researchers will collect information on how well the treatment works and how it affects the patients’ quality of life. This includes looking at how the cancer responds to the treatment and how long patients live without the disease getting worse. The study will also involve collecting samples from patients to better understand how the treatment affects the body and to look for markers that might predict how well the treatment works. The study is expected to continue for several years to gather enough information to determine the effectiveness and safety of this new treatment strategy.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests.

A negative pregnancy test is required for women of child-bearing potential within 24 hours before the administration of the investigational product.

2 intrapleural photodynamic therapy (PDT)

The first treatment involves intrapleural photodynamic therapy (PDT) using video-assisted thoracoscopy. This procedure targets the malignant pleural mesothelioma lesions.

During this procedure, fresh pleural tumor biopsies are collected for further analysis.

3 nivolumab administration

Following the PDT, Nivolumab is administered as an immunotherapy treatment. This is given as an intravenous infusion.

The dosage is 10 mg/mL, and the frequency and duration of administration are determined by the study protocol.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the patient’s response to treatment and any potential side effects.

Blood samples are collected before PDT, during Nivolumab treatment, and at the time of progression to monitor circulating tumor DNA (ctDNA) and biomarkers.

5 quality of life assessment

The patient’s quality of life is assessed using a dedicated questionnaire before and after treatment.

Chest pain is evaluated using a visual scale to monitor any changes during the study.

6 end of study

The study is estimated to conclude by January 2, 2029. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Patients must be at least 18 years old.
  • Patients should have lost less than 10% of their body weight.
  • Tumor tissue must be available, either from previous samples or new ones.
  • Patients must not have any reasons that prevent them from using 5-ALA, PDT, or Nivolumab. These are specific treatments used in the study.
  • Patients need to provide written consent after being informed about the study.
  • The decision to include the patient in the study must be made by a special group of doctors who focus on this condition.
  • Patients must be covered by social security for regular medical care.
  • Women who can have children must use a very effective form of birth control starting 28 days before the first dose of the study treatment and continue for 5 months after the last dose.
  • Women who can have children must have a negative pregnancy test within 24 hours before receiving the study treatment.
  • Patients must have an ECOG Performance status of 0-1. This is a scale that measures how well patients can perform daily activities.
  • Patients must have a type of cancer called unresectable Malignant Pleural Mesothelioma. “Unresectable” means it cannot be removed by surgery.
  • Patients should have this type of cancer that has come back after one or two treatments with specific chemotherapy drugs. Patients who cannot or do not want chemotherapy may also join.
  • Patients must have shown that their cancer has progressed after previous chemotherapy treatments.
  • Patients must be eligible for a treatment called Nivolumab, as confirmed by experts.
  • The disease must be measurable according to specific guidelines used for this type of cancer.
  • The cancer must be in a location that can be treated with a local procedure called PDT during a type of surgery called thoracoscopy.
  • The diagnosis of the cancer must be confirmed by expert pathologists.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a different type of cancer in the past, unless it was treated and cured.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or injury.
  • Patients with a history of drug or alcohol abuse.
  • Patients with certain infections that could affect the study results.
  • Patients who have received certain treatments that might interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
09.05.2022

Trial locations

Investigated drugs:

Nivolumab is a type of immunotherapy used in this clinical trial. It works by helping the body’s immune system recognize and attack cancer cells. In this study, it is used to treat patients with malignant pleural mesothelioma, a type of cancer that affects the lining of the lungs.

Intrapleural Photodynamic Therapy (PDT) is a treatment that involves using a special light-sensitive drug and a light source to destroy cancer cells. In this trial, the therapy is administered through a procedure called Video-Assisted Thoracoscopy (VATS), which allows doctors to access the pleural space in the chest to deliver the treatment directly to the affected area.

Investigated diseases:

Malignant Pleural Mesothelioma – This is a rare and aggressive cancer that forms in the thin layer of tissue covering the lungs and chest wall, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to cellular changes over time. The disease often begins with symptoms like chest pain, shortness of breath, and fluid buildup around the lungs. As it progresses, the cancer can spread to nearby tissues and organs, causing more severe respiratory issues and discomfort. The progression of malignant pleural mesothelioma can vary, but it typically involves the gradual worsening of symptoms and increased difficulty in breathing.

Trial ID:
2024-514103-33-00
Protocol code:
2019_41
NCT ID:
NCT04400539
Trial Phase:
Therapeutic exploratory (Phase II)

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