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Study of Nivolumab or Placebo for Patients with Removed Esophageal or Gastroesophageal Junction Cancer

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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 treatment called nivolumab on patients who have had surgery to remove esophageal cancer or gastroesophageal junction cancer. These types of cancer occur in the tube that connects the throat to the stomach and the area where the esophagus meets the stomach. The study involves patients who have undergone surgery after receiving chemotherapy and radiation therapy before the operation. The purpose of the study is to compare how well patients do without the cancer coming back when treated with nivolumab compared to a placebo.

Nivolumab, also known by its code name BMS-936558, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The study will observe patients over a period to see if the cancer returns or if they remain disease-free. The main goal is to see how long patients can live without the cancer coming back, which is referred to as disease-free survival. Additionally, the study will look at overall survival, which is the length of time patients live after starting the study, regardless of whether the cancer returns.

Participants in the study will receive either nivolumab or a placebo, and neither the patients nor the researchers will know which treatment each patient is receiving. This is known as a double-blind study, which helps ensure that the results are not influenced by expectations about the treatment. The study aims to provide valuable information on whether nivolumab can help prevent the return of esophageal or gastroesophageal junction cancer after surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after the removal of esophageal or gastroesophageal junction cancer.

    Eligibility includes having Stage II/III carcinoma and completion of pre-operative chemoradiotherapy followed by surgery.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either nivolumab or a placebo.

    This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    Nivolumab is administered as a solution for infusion, given intravenously.

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

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for disease-free survival, which is the time between randomization and the first date of cancer recurrence or death.

    Secondary outcomes include overall survival, which is the time from randomization to death from any cause.

  5. Step 5

    Study completion

    The study is estimated to conclude by October 11, 2025.

    Participants will be informed of the study results and any relevant findings related to their health.

Who can join the trial?

6 criteria

  • Patients must have had a type of cancer called adenocarcinoma or squamous cell carcinoma in the esophagus or where the esophagus meets the stomach, known as the gastroesophageal junction.
  • Patients should have been diagnosed with Stage II or III cancer of the esophagus or gastroesophageal junction. Stage II and III refer to the extent and spread of the cancer.
  • Patients must have completed a treatment called pre-operative chemoradiotherapy, which is a combination of chemotherapy and radiation therapy given before surgery.
  • Patients should have undergone surgery to remove the cancer and have been found to have residual pathologic disease, meaning some cancer cells were still present after surgery, but the surgery successfully removed all visible cancer with clear margins.
  • Both male and female patients are eligible to participate.
  • The study includes patients from vulnerable populations, which means it considers those who might need special protection or care.
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Investigated drugs

Nivolumab is a medication used in this clinical trial to help prevent the return of cancer in patients who have had surgery to remove esophageal or gastroesophageal junction cancer. It works by helping the immune system recognize and attack cancer cells.

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 well-established in medical literature as an immunotherapy used in the treatment of various cancers. The main therapeutic indication for nivolumab in this context is to improve disease-free survival in patients with resected esophageal or gastroesophageal junction cancer. At the molecular level, nivolumab works by blocking the PD-1 receptor on T-cells, enhancing the immune system's ability to attack cancer cells. It is classified as a monoclonal antibody and falls under the category of immune checkpoint inhibitors.

Investigated diseases

  • Adenocarcinoma of the Esophagus

    This is a type of cancer that begins in the glandular cells of the esophagus, which are responsible for producing mucus and other fluids. It typically occurs in the lower part of the esophagus and is often associated with a condition called Barrett's esophagus. The disease progresses as the cancer cells grow and invade deeper layers of the esophagus and potentially spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, chest pain, and weight loss. Over time, the tumor can obstruct the esophagus, making it difficult to eat or drink.

  • Squamous Cell Carcinoma of the Esophagus

    This cancer originates in the flat, thin cells lining the esophagus and is more common in the upper and middle parts of the esophagus. It is often linked to smoking and alcohol consumption. As the disease progresses, the cancer cells can invade deeper tissues and spread to other parts of the body. Symptoms may include difficulty swallowing, chest pain, and unintentional weight loss. The tumor can grow to block the esophagus, leading to further complications.

  • Adenocarcinoma of the Gastroesophageal Junction

    This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It often arises from Barrett's esophagus, a condition where the normal lining of the esophagus changes due to acid reflux. The disease progresses as cancer cells invade surrounding tissues and may spread to lymph nodes and distant organs. Symptoms can include difficulty swallowing, chest pain, and weight loss. As the tumor grows, it can obstruct the passage of food, leading to nutritional issues.

  • Squamous Cell Carcinoma of the Gastroesophageal Junction

    This is a rare type of cancer that occurs at the junction of the esophagus and stomach, originating from the squamous cells. It is less common than adenocarcinoma in this location and is associated with risk factors like smoking and alcohol use. The disease progresses as the cancer cells invade deeper layers and potentially spread to other parts of the body. Symptoms may include difficulty swallowing, chest pain, and weight loss. The tumor can grow to obstruct the gastroesophageal junction, causing further complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509360-24-00Protocol codeCA209-577Estimated enrolment1 082 patientsSponsorBristol Myers Squibb International Corporation

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