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Study on Cetrelimab for Patients with Advanced Cancers

Verified siteInvestigationalNo placebo

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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 studying the effects of a new treatment for people with advanced cancers, specifically those with solid tumors. The treatment being tested is called cetrelimab, which is a type of medication known as an anti-PD-1 monoclonal antibody. This medication is designed to help the body's immune system recognize and fight cancer cells more effectively. The study aims to evaluate the safety and effectiveness of cetrelimab in treating various types of advanced cancers, including non-small cell lung cancer, melanoma, kidney cancer, bladder cancer, small cell lung cancer, stomach/esophageal cancer, and certain types of colorectal cancer.

The trial will be conducted in several parts. Initially, the study will determine the best dose of cetrelimab to use. Following this, the study will assess how well cetrelimab works in treating the selected advanced cancers. The medication will be administered in two forms: as a solution for infusion, which is given through a vein, and as a solution for injection, which is given under the skin. The study will also compare these two methods of delivery to see which one provides the best results.

Participants in the study will receive cetrelimab and will be monitored for any side effects and the overall response of their cancer to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of cetrelimab. The study will continue until the researchers gather enough information to understand the treatment's safety and effectiveness. The ultimate goal is to find a new and effective treatment option for people with advanced cancers.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking the performance status and thyroid function, and ensuring a negative pregnancy test for females of childbearing potential.
Participants must have a disease that can be evaluated. For certain parts of the study, tumor tissue must be available for additional studies.
Step 2
Treatment administration - part 1
In this phase, the medication JNJ-63723283, also known as cetrelimab, is administered to identify the recommended dose for further study.
The medication is given as a solution for infusion through an intravenous route.
Step 3
Treatment administration - part 2
This phase assesses the anti-tumor activity of JNJ-63723283 at the recommended dose in patients with specific advanced cancers.
The medication continues to be administered intravenously.
Step 4
Treatment administration - part 3 and 4
These phases aim to determine a dose regimen for subcutaneous delivery of JNJ-63723283 that achieves similar exposure as the intravenous delivery.
The medication is administered as a solution for injection through a subcutaneous route.
Step 5
Monitoring and evaluation
Throughout the study, the frequency and severity of any side effects are monitored.
The overall response rate to the treatment is evaluated using specific criteria for advanced solid tumors.
Step 6
Study completion
The study is estimated to conclude by January 24, 2026.
Final evaluations are conducted to assess the outcomes and gather data for further analysis.

Who can join the trial?

6 criteria

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
Must have thyroid function laboratory values within the normal range. This means the thyroid gland, which helps control metabolism, is working properly.
Females who can have children must have a negative serum pregnancy test. This is a blood test to ensure they are not pregnant.
Must be willing and able to follow the rules and restrictions of the study.
Must have evaluable disease. This means the disease can be measured or assessed in some way. For Part 2, participants need to have tumor tissue available for additional studies. A fresh tumor biopsy is preferred, but older tissue samples may be used if they meet specific storage conditions. If no suitable tissue is available, a new biopsy is required.
Must have evaluable disease for all parts of the study.

Who cannot join the trial?

5 criteria

Patients with **advanced stage solid tumors** cannot participate. These are cancers that have spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Both **male** and **female** patients are eligible, but if a patient does not meet other criteria, they cannot participate.
Patients who are considered part of a **vulnerable population** cannot participate. This refers to groups of people who might need special protection or care.

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Verified sites

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

Verified
Hospital Universitario 12 De Octubre
Madrid, Spain
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Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Cracow, Poland
Verified
Virgen del Rocío University Hospital
Sevilla, Spain

Trial locations

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Investigated drugs

JNJ-63723283 is an experimental medication being studied for its potential to treat advanced cancers. It is a type of monoclonal antibody that targets PD-1, a protein on the surface of immune cells. By blocking PD-1, this medication may help the immune system recognize and attack cancer cells more effectively. The study aims to determine the best dose for this medication and to evaluate its ability to reduce tumor size in patients with various types of advanced cancers, including lung, melanoma, kidney, bladder, stomach, and certain types of colorectal cancer.

Cetrelimab

What is already known about the treatment

JNJ-63723283 – This medication is administered as an injection, either intravenously (IV) or subcutaneously (SC). It is currently being studied in clinical trials for its effectiveness in treating advanced stage solid tumors, including various types of cancer such as non-small cell lung cancer, melanoma, and gastric cancer. JNJ-63723283 is an anti-PD-1 monoclonal antibody, which works by blocking the PD-1 protein on immune cells, thereby enhancing the body's immune response against cancer cells. It falls under the pharmacological classification of immune checkpoint inhibitors, which are designed to help the immune system recognize and attack cancer cells more effectively.

Investigated diseases

Advanced Stage Solid Tumors – These are cancers that have progressed to a stage where they have spread beyond their original site to other parts of the body. Solid tumors can occur in various organs and tissues, such as the lungs, kidneys, bladder, and stomach. As the disease advances, the tumors may grow larger and invade nearby tissues or organs. This progression can lead to a range of symptoms depending on the location and size of the tumors. The disease is characterized by its ability to metastasize, meaning it can spread to distant parts of the body. The progression of advanced stage solid tumors can vary greatly depending on the type of cancer and individual patient factors.