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Study on the Safety of Radiation and Nivolumab for Patients with Esophageal Cancer

Verified siteRegistered drugNo 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 treatment of esophageal cancer, a type of cancer that affects the tube connecting the throat to the stomach. The study involves the use of a medication called nivolumab, which is also known by its code names BMS936558 and ABP 206. Nivolumab is administered as a solution through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. The purpose of this study is to evaluate the safety and feasibility of using nivolumab in combination with radiation therapy for treating esophageal cancer.

Participants in the study will receive treatment with nivolumab and radiation therapy. The study will monitor the safety of this treatment by observing any side effects and changes in health indicators such as blood tests and vital signs. The study will also assess how well the treatment can be carried out and how patients respond to it. The trial is designed to gather information over a period of time to understand the potential benefits and risks of this treatment approach.

The study aims to provide insights into the overall survival of patients, which refers to the time from the start of treatment until death from any cause. It will also look at how the cancer responds to treatment both within the area that receives radiation and outside of it. For some participants, the study will measure how long they live without the cancer getting worse or coming back after surgery. Additionally, the study will evaluate the quality of life of participants using questionnaires. The trial is expected to continue until the end of 2025.

The research process

The trial runs in 7 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 a review of medical history, physical examination, and laboratory tests to ensure adequate organ function and overall health status.
Step 2
Treatment planning
A treatment plan is developed based on the specific cohort you are assigned to. This plan includes the type of therapy you will receive, such as palliative radiotherapy, definitive chemoradiation, or neoadjuvant chemoradiotherapy followed by surgery.
Step 3
Nivolumab administration
You will receive nivolumab, a medication administered through an intravenous infusion. The dosage is 10 mg/mL, and the frequency and duration will be determined by the study protocol specific to your cohort.
Step 4
Radiotherapy
Radiotherapy is administered as part of the treatment regimen. The specifics, such as the number of sessions and duration, depend on the cohort and individual treatment plan.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess safety and treatment response. This includes checking vital signs, conducting laboratory tests, and evaluating any side effects or adverse events.
Step 6
Completion of treatment
Upon completion of the treatment regimen, a final assessment is performed to evaluate the overall response to the therapy and any long-term effects.
Step 7
Long-term follow-up
After the treatment phase, long-term follow-up is conducted to monitor overall survival, disease progression, and quality of life. This may involve periodic visits and assessments as outlined in the study protocol.

Who can join the trial?

12 criteria

Must be older than 18 years.
For Cohort A: Eligible for **palliative fractionated radiotherapy** for esophageal or gastroesophageal cancer, with expected survival of more than 3 months, and not having a large tumor. The treatment is intended to relieve swallowing difficulties or pain, and other treatments can be delayed until after the study treatment if possible.
For Cohort B: Eligible for **definitive chemoradiation** for localized but inoperable esophageal or gastroesophageal cancer, with no cancer spread outside the radiation area. Must be able to follow the planned chemoradiotherapy.
For Cohort C: Eligible for **neoadjuvant chemoradiotherapy** and surgery for esophageal or gastroesophageal cancer, with no cancer spread outside the radiation area. Must be able to follow the planned chemoradiotherapy and surgery.
Must have a type of esophageal cancer called **squamous cell carcinoma** or **adenocarcinoma**, confirmed by a tissue sample.
Must be able to walk and perform daily activities, with a performance status of **ECOG 0 or 1** (a scale that measures how well a person can perform daily activities).
Must have adequate organ function based on medical examination and lab tests, including specific levels for blood cells, kidney function, liver function, and blood clotting.
Women who can have children must have a negative pregnancy test before starting the study and must not be breastfeeding.
Women who can have children should use a highly effective method to prevent pregnancy for 23 weeks after the last dose of the study drug.
Men who are sexually active with women who can have children must agree to use contraception during the study and for 7 months after the last dose of the study drug.
Must provide signed informed consent and agree to cooperate with the treatment and follow-up as required by the study.
If having difficulty swallowing with a score greater than 2, a feeding tube should be inserted before starting radiotherapy.

Who cannot join the trial?

6 criteria

Patients with other types of cancer besides esophageal cancer cannot participate.
Individuals who have experienced severe side effects from similar treatments in the past are excluded. Severe side effects are serious health problems caused by the treatment.
Patients with abnormal blood test results, which include biochemistry (chemical substances in the blood) and hematology (blood cells), are not eligible.
People with unstable vital signs (such as heart rate, blood pressure, or temperature) cannot join the study. Vital signs are basic measurements of body functions.
Individuals with poor performance status, meaning they are unable to carry out daily activities, are excluded.
Participants who are part of a vulnerable population, such as those unable to give consent, are not allowed to join.

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Verified sites

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Nivolumab
is a medication used in this trial to help the body's immune system fight cancer cells. It is a type of immunotherapy known as a checkpoint inhibitor, which works by blocking a protein that prevents the immune system from attacking cancer cells. This allows the immune system to better recognize and destroy cancer cells.
Irradiation
is a therapy used in this trial to target and kill cancer cells in the esophagus. It involves using high-energy rays, similar to X-rays, to damage the DNA of cancer cells, which stops them from growing and dividing. This treatment is often used to shrink tumors and improve symptoms in patients with esophageal cancer.

Nivolumab

What is already known about the treatment

Nivolumab – Nivolumab 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 safety and feasibility in treating esophageal cancer. The main therapeutic indication for Nivolumab is its use in various types of cancer, including esophageal cancer, where it helps the immune system recognize and attack cancer cells. At the molecular level, Nivolumab works by blocking the PD-1 protein on immune cells, which enhances the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Esophageal Cancer – Esophageal cancer is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It typically begins in the cells lining the esophagus and can develop into two main types: squamous cell carcinoma and adenocarcinoma. The disease often progresses by growing into the wall of the esophagus and can spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, weight loss, and chest pain. As the cancer advances, it can obstruct the esophagus, making it difficult to eat or drink. The progression of esophageal cancer can vary, with some cases growing slowly and others spreading more rapidly.