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Study on Tislelizumab for Cancer Patients with Molecular Residual Disease After Standard Treatment

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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 patients with a condition known as molecular residual disease (MRD), which can occur after standard cancer treatments. The study is investigating the effectiveness of a medication called Tislelizumab, which is given as a solution for infusion, compared to a placebo. Tislelizumab is being tested in patients who have completed their standard cancer treatment but still show signs of MRD, which means there are small amounts of cancer cells that remain in the body and can be detected through specific tests.

The purpose of the study is to see if Tislelizumab can help improve the time patients remain free from cancer after treatment, known as disease-free survival. Patients will receive either Tislelizumab or a placebo and will be monitored over a period of time to assess their health and any changes in their condition. The study will involve regular check-ups and assessments to track the progress of the patients and the effectiveness of the treatment.

Participants in the study will be those who have completed their initial cancer treatments, such as surgery or chemotherapy, and have been identified as having MRD. The study will include patients with certain types of cancer, such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, and soft-tissue sarcoma. The trial aims to provide valuable information on whether Tislelizumab can offer additional benefits in preventing cancer recurrence in these patients.

The research process

The trial runs in 6 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 previous treatments.
A written informed consent form is signed to confirm understanding and agreement to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate health status and ensure all criteria are met.
Blood samples are collected for ctDNA analysis to determine molecular residual disease (MRD) status.
Step 3
Randomization
Participants are randomly assigned to receive either the trial drug, tislelizumab, or a placebo.
This process ensures unbiased distribution of treatments among participants.
Step 4
Treatment phase
The treatment involves receiving tislelizumab or placebo through intravenous infusion.
The frequency and dosage are determined by the study protocol and are administered under medical supervision.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess health status and any side effects.
Follow-up visits include imaging tests and questionnaires to evaluate disease-free survival and quality of life.
Step 6
End of study
The study concludes with a final assessment to evaluate the overall health and outcomes.
Participants are informed of the study results and any further recommendations for their health care.

Who can join the trial?

23 criteria

Must be at least 18 years old.
Must have a good general health status, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) Performance Status, with a score of 0 or 1. This means you are fully active or have some symptoms but can still do light work.
Must have proper functioning of organs, shown by specific blood test results:
Absolute neutrophil count (ANC) should be at least 1.5 x 10⁹/L. Neutrophils are a type of white blood cell important for fighting infections.
Platelets should be at least 100 x 10⁹/L. Platelets help with blood clotting.
Hemoglobin should be at least 90 g/L. Hemoglobin is a protein in red blood cells that carries oxygen.
International normalized ratio (INR) or prothrombin time (PT) should be 1.5 times the upper limit of normal or less. These tests measure how well your blood clots.
Activated partial thromboplastin time (aPTT) should be 1.5 times the upper limit of normal or less. This is another test for blood clotting.
Serum total bilirubin should be 1.5 times the upper limit of normal or less. Bilirubin is a substance made during the breakdown of red blood cells.
Aspartate and alanine aminotransferase (AST and ALT) should be 3 times the upper limit of normal or less. These are liver enzymes.
Creatinine clearance should be at least 60 mL/min. This measures how well your kidneys are working.
Must have social security in compliance with French law related to biomedical research.
Must understand, sign, and date a written consent form before any study-specific procedures are done. Must be able and willing to attend study visits and follow procedures.
Women who can have children must agree to use a highly effective birth control method during the study and for at least 120 days after the last dose of the study drug. They must also have a negative pregnancy test within 7 days before the first dose of the study drug.
Men who are not sterile must agree to use a highly effective birth control method during the study and for at least 120 days after the last dose of the study drug.
Must have completed surgical and peri-operative treatments according to international guidelines.
Must have finished standard curative treatment for at least 3 months and no more than 4.5 months, and must not have had standard treatment for at least 3 weeks before blood sampling for ctDNA analyses. ctDNA stands for circulating tumor DNA, which is DNA from cancer cells found in the blood.
Must not have had a blood transfusion at least 1 week before blood sampling for ctDNA analyses.
Must have a specific type of cancer, such as stage II-III non-small cell lung cancer (NSCLC), stage II-III colorectal cancer, stage I-III pancreatic cancer, or grade 3 soft-tissue sarcoma in the limb or trunk wall.
Must have enough stored tumor material for ctDNA and other research analyses.
Must have a valid ctDNA test result before being randomly assigned to a treatment group.
Must not have had previous immunotherapy, which includes treatments like anti-PD-1 or anti-PD-L1.
Must show no evidence of disease on imaging tests according to specific criteria called RECIST 1.1.

Who cannot join the trial?

1 criterion

Patients who do not have a positive status for molecular residual disease (MRD) 3 to 4.5 months after finishing their standard treatment cannot participate. Molecular residual disease (MRD) means there are still tiny amounts of cancer cells in the body that are not detectable with regular tests.

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Verified sites

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

Centre Hospitalier Regional Et Universitaire De Brest
Verified
Brest, France
Centre Hospitalier Universitaire De Poitiers
Verified
Poitiers, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Tislelizumab is a medication being studied for its effectiveness in cancer patients who have a molecular residual disease. It is being tested to see if it can help improve the time patients remain free from cancer after they have completed their standard treatment aimed at curing the disease. The trial is focused on patients who still show signs of the disease at a molecular level, even after their initial treatment.

What is already known about the treatment

Tislelizumab – Tislelizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in cancer patients who have a positive status for molecular residual disease (MRD) after completing standard curative treatment. The main therapeutic indication is to improve disease-free survival in these patients. Tislelizumab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Molecular Residual Disease (MRD) Positive Status – This condition refers to the presence of small amounts of cancer cells in the body after treatment, which are not detectable with standard imaging techniques. It is often identified through sensitive molecular tests that can detect minimal residual disease. MRD positive status indicates that there are still cancer cells remaining, which may lead to a relapse if not addressed. The progression of this condition involves monitoring the levels of these residual cells over time to assess the risk of cancer returning. It is a critical factor in determining the effectiveness of treatment and the need for additional therapy.