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Study of Pembrolizumab in Patients with Esophageal Cancer Undergoing Chemoradiotherapy

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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 a type of cancer known as esophageal carcinoma, which affects the esophagus, the tube that carries food from the mouth to the stomach. The study is investigating the effects of a medication called pembrolizumab, also known by its code name MK-3475, compared to a placebo. Pembrolizumab is a type of treatment that helps the immune system fight cancer cells. The purpose of the study is to see how well pembrolizumab works when given alongside standard cancer treatments, which include chemotherapy and radiation therapy, in people with esophageal carcinoma.

Participants in the study will receive either pembrolizumab or a placebo, in addition to their regular cancer treatment. The study will last for a period of time during which participants will receive treatment and be monitored for any changes in their health. The study aims to understand how pembrolizumab affects the length of time participants live without the cancer getting worse and overall survival. The study will also look at any side effects that participants may experience during the treatment.

Other medications involved in the study include calcium folinate, folinic acid, fluorouracil, cisplatin, and oxaliplatin, which are commonly used in cancer treatment. These medications are given as solutions for infusion, meaning they are administered directly into the bloodstream through a vein. The study is designed to provide valuable information about the effectiveness and safety of pembrolizumab in treating esophageal carcinoma, potentially leading to improved treatment options for patients with this type of cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A healthcare professional will explain the study procedures, potential risks, and benefits. Consent is required to proceed.

  2. Step 2

    Treatment phase

    Participants receive either pembrolizumab or a placebo, administered as a solution for infusion. The specific dosage and frequency are determined by the study protocol.

    In addition to the study medication, participants undergo concurrent definitive chemoradiotherapy (dCRT), which involves chemotherapy and radiation therapy.

  3. Step 3

    Medication details

    The medications used in the trial include calcium folinate, folinic acid, fluorouracil, cisplatin, and oxaliplatin. These are administered as solutions for infusion or injection, depending on the specific drug.

    The healthcare team will provide detailed instructions on the administration schedule and any necessary precautions.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the participant's response to treatment and to identify any side effects. This includes physical examinations, blood tests, and imaging studies.

    Participants are required to attend scheduled follow-up visits to ensure ongoing evaluation of their health status.

  5. Step 5

    End of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the study treatment.

    Participants may be asked to continue follow-up visits for a specified period to monitor long-term outcomes and any delayed side effects.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of certain types of esophageal cancer, which includes:
    • ESCC: Esophageal Squamous Cell Carcinoma
    • GEJC: Gastroesophageal Junction Cancer
    • EAC: Esophageal Adenocarcinoma
    • Must be suitable for a treatment called dCRT (definitive Chemoradiotherapy)
    • Must not be eligible for surgery that aims to cure the cancer, as determined by a qualified doctor
    • Must not need tumor removal surgery during the study
    • Must have an ECOG performance status of 0 to 1, which means being fully active or having some symptoms but nearly fully active
    • Must have adequate organ function, meaning the organs are working well enough
    • Male participants must use effective birth control methods and not donate sperm during the study and for 90 days after the last dose of chemotherapy
    • Female participants who can have children must use highly effective birth control or be abstinent during the study and for a certain period after the last dose of treatment
    • Female participants must not be pregnant or breastfeeding

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides esophageal carcinoma cannot participate.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, are excluded.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, are not eligible.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot join the study.
  • Patients who have received an organ transplant are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to any of the study drugs are not eligible.
  • Patients who have received another investigational drug within the last 4 weeks are excluded.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, cannot join the study.
  • Patients with a history of heart attack or stroke within the last 6 months are not eligible.
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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is being tested to see if it can improve outcomes for people with esophageal cancer when used alongside standard treatments like chemotherapy and radiation therapy. The goal is to see if pembrolizumab can help stop the cancer from growing or spreading and improve survival rates.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials for its effectiveness in treating esophageal carcinoma, a type of cancer that affects the esophagus. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a specific protein called PD-1 on immune cells, which can help the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Esophageal carcinoma – Esophageal carcinoma is a type of cancer that occurs in the esophagus, the long tube that carries food from the throat to the stomach. It begins in the cells lining the esophagus and can develop into a tumor. As the disease progresses, the tumor can grow and invade deeper layers of the esophagus wall. It may spread to nearby lymph nodes and other organs, such as the liver or lungs. Symptoms often include difficulty swallowing, weight loss, and chest pain. The progression of the disease can lead to obstruction of the esophagus, making it difficult to eat or drink.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501531-16-00Protocol codeMK-3475-975Estimated enrolment684 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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