Study of Relatlimab, Nivolumab, and Drug Combination for Patients with Advanced Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced malignant tumors, which are types of cancer that have spread or are difficult to remove surgically. The study involves testing combinations of different medications to see how they work together in treating these cancers. The medications being tested include Relatlimab, which is an anti-LAG-3 monoclonal antibody, Nivolumab, an anti-PD-1 monoclonal antibody, Ipilimumab, an anti-CTLA-4 monoclonal antibody, and Linrodostat Mesylate, an IDO1 inhibitor. Some of these medications are given through an injection into a vein, while others are taken as tablets.

The purpose of the study is to determine the safety and tolerability of these medication combinations and to observe their effects on the tumors. Participants will receive different combinations of these medications, and their health will be monitored closely to identify any side effects or changes in their condition. The study aims to find out how well these combinations can control the disease and how long any positive effects last.

Throughout the study, participants will undergo regular health checks and tests to track their progress. The study will help researchers understand more about how these medications work together and their potential benefits for people with advanced cancers. The trial is expected to continue until 2026, providing valuable information on the effectiveness and safety of these treatment combinations.

1 initial assessment

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

Eligibility criteria include confirmation of an incurable solid malignancy that is advanced, availability of tumor tissue for analysis, and a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale.

2 treatment phase 1

The first phase of treatment involves the administration of relatlimab and nivolumab intravenously. These are monoclonal antibodies designed to help the immune system fight cancer.

Additionally, linrodostat mesylate is taken orally. This is an IDO1 inhibitor, which may help in reducing tumor growth.

The dosage and frequency of administration are determined by the study protocol and are monitored closely by the medical team.

3 treatment phase 2

In the second phase, the treatment may include a combination of relatlimab, nivolumab, and ipilimumab. Ipilimumab is another monoclonal antibody administered intravenously.

The combination aims to enhance the immune response against cancer cells.

The duration and specific regimen are based on individual response and tolerance.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess safety and effectiveness. This includes clinical laboratory tests and imaging studies.

Adverse events and any abnormalities are recorded to ensure participant safety.

The response to treatment is evaluated using criteria such as Objective Response Rate and Disease Control Rate.

5 end of trial

The trial is estimated to conclude by November 2026. At the end of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Participants may be offered follow-up care or additional treatment options based on the results.

Who Can Join the Study?

The patient must have a confirmed diagnosis of an incurable solid cancer that is advanced, meaning it has spread to other parts of the body or cannot be removed by surgery. The cancer must be measurable according to specific guidelines called RECIST v1.1.
The patient must have available tumor tissue for testing. This means a sample of the cancer is needed for further analysis.
The patient must have an ECOG Performance Status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A status of 0 means the patient is fully active, while 1 means the patient is restricted in physically strenuous activity but can carry out light work.
The patient must be within the age range of adults, which typically means 18 years or older.
Both male and female patients are eligible to participate.
The study may include individuals considered part of a vulnerable population, which can mean people who might need special protection or consideration.

Who Cannot Join the Study?

Patients with certain types of advanced malignant tumors cannot participate. Advanced malignant tumors are cancers that have spread to other parts of the body and are in a more severe stage.
Patients who have not met the age requirements for the study cannot participate. The study is open to specific age groups only.
Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups that may need special protection, such as children, pregnant women, or those with certain disabilities.
Patients who do not meet the safety and health criteria set by the study cannot participate. This includes having certain health conditions or taking medications 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
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Idrntvsr Ropmifvjy Pwh Ln Sheetf Dly Tycaik Dsia Afzmktq Imbr Supobo	Meldola	Italy
Aqwmrivdfd Prtkdtim Hgrywlrj Dr Mbwatvvgg	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	25.02.2019
Italy	Not recruiting	25.02.2019
Spain	Not recruiting	25.02.2019

Trial locations

Investigated drugs:

Relatlimab is a monoclonal antibody that targets LAG-3, a protein involved in regulating the immune system. By blocking LAG-3, relatlimab may help the immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with other medications to treat advanced malignant tumors.

Nivolumab is a monoclonal antibody that targets PD-1, a protein on the surface of immune cells. By blocking PD-1, nivolumab can enhance the immune system’s ability to fight cancer. It is used in this trial in combination with other medications to treat advanced malignant tumors.

BMS-986205 is an IDO1 inhibitor, which means it blocks the activity of the IDO1 enzyme. This enzyme can suppress the immune system, so by inhibiting it, BMS-986205 may help the immune system attack cancer cells. It is being tested in combination with other medications in this trial for advanced malignant tumors.

Ipilimumab is a monoclonal antibody that targets CTLA-4, another protein that can inhibit the immune system. By blocking CTLA-4, ipilimumab may enhance the immune response against cancer cells. In this trial, it is used in combination with other medications to treat advanced malignant tumors.

Investigated diseases:

Neoplasm malignant

Advanced Malignant Tumors – These are cancers that have progressed to a stage where they have spread beyond their original site to other parts of the body. The disease is characterized by the uncontrolled growth of abnormal cells that can invade nearby tissues and organs. As the tumors advance, they may cause symptoms depending on their location and size, such as pain, fatigue, or weight loss. The progression of these tumors can vary widely, with some growing slowly over time, while others may spread rapidly. The complexity of advanced malignant tumors often requires a comprehensive approach to understand their behavior and impact on the body.

Trial ID:

2023-508207-21-00

Protocol code:

CA224-048

NCT ID:

NCT03459222

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Relatlimab, Nivolumab, and Drug Combination for Patients with Advanced Cancer

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