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Study on MK-2870, Pembrolizumab, and Chemotherapy for Patients with Advanced Gastroesophageal 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 treatments for gastroesophageal cancer, which includes types like gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, and esophageal adenocarcinoma. The study will explore the effects of a combination of treatments, including a new drug called MK-2870, also known as sacituzumab tirumotecan, and an existing medication called pembrolizumab (also known as Keytruda). Additionally, various chemotherapy drugs will be used, such as capecitabine, fluorouracil, oxaliplatin, and calcium folinate. Other medications involved in the study include glucocorticoids, H2-receptor antagonists, antihistamines, and a combination of buclizine hydrochloride, paracetamol, and codeine phosphate.

The purpose of the study is to evaluate the safety and effectiveness of these combination therapies in treating gastroesophageal cancer. Participants will receive these treatments through different methods, such as oral use or intravenous infusion, which means the medication is given directly into a vein. The study will begin with a phase to ensure the safety and tolerability of the treatments, followed by an assessment of how well the treatments work in reducing the size of the cancer or stopping its growth.

Throughout the study, participants will be closely monitored for any side effects or adverse reactions to the treatments. The study aims to provide valuable information on the potential benefits and risks of these combination therapies for individuals with advanced gastroesophageal cancer. The trial is expected to continue until 2029, with recruitment starting in 2024.

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

    Upon joining the study, the diagnosis of gastroesophageal cancer is confirmed through histological or cytological methods.

    The condition should be locally advanced, unresectable, or metastatic, and not positive for a specific protein called HER2/neu.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure adequate organ function and a performance status that allows participation.

    A life expectancy of at least six months is required.

  3. Step 3

    Treatment phase

    The treatment involves a combination of medications administered in different forms.

    The medications include capecitabine (oral use), MK-2870 (intravenous infusion), paracetamol (oral use), fluorouracil (intravenous infusion), calcium folinate (intravenous infusion), oxaliplatin (intravenous infusion), and pembrolizumab (intravenous infusion).

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to evaluate safety and tolerability.

    The objective response rate is assessed using specific criteria to determine the effectiveness of the treatment.

  5. Step 5

    Completion of study

    The study is estimated to conclude by April 2029.

    Participants are monitored for any adverse events and the overall survival rate is evaluated.

Who can join the trial?

10 criteria

  • The patient must have a confirmed diagnosis of **gastroesophageal adenocarcinoma** that has not been treated before and is either locally advanced, cannot be surgically removed, or has spread to other parts of the body.
  • The patient should not need surgery to remove the tumor during the study treatment.
  • The cancer must not be **HER2/neu positive**, which means it does not have a specific protein that can affect cancer growth.
  • The patient must provide a sample of the tumor tissue, either from a previous biopsy or a new one.
  • If the patient had side effects from past cancer treatments, they must have improved to a mild level or returned to their normal state. If the side effects are related to hormones and are being treated with hormone replacement therapy, the patient can still participate.
  • The patient must have organs that are working well enough to handle the treatment.
  • The patient must have a tumor that can be measured according to specific criteria used to assess cancer size and response to treatment.
  • The patient must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work. This assessment should be done within 3 days before starting the study treatment.
  • The patient must have a life expectancy of at least 6 months.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

4 criteria

  • Patients with other types of cancer besides gastroesophageal cancer cannot participate.
  • Patients who have not reached the required age range for the study are excluded.
  • Patients who are part of a vulnerable population, meaning those who might need special protection or care, are not eligible.
  • Patients who do not meet the specific health and safety requirements for the study will be excluded.
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Investigated drugs

  • MK-2870

    is an investigational medication being studied for its potential to treat certain types of advanced cancers. In this trial, it is being tested to see how safe and tolerable it is when used in combination with other treatments for gastroesophageal adenocarcinoma, a type of cancer that affects the stomach and esophagus.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. In this trial, pembrolizumab is used alongside other treatments to see if it can improve outcomes for patients with advanced gastroesophageal adenocarcinoma.

  • Chemotherapy

    refers to a group of cancer-fighting drugs that work by killing rapidly dividing cells, including cancer cells. In this study, chemotherapy is used in combination with other treatments to evaluate its effectiveness in treating advanced gastroesophageal adenocarcinoma.

What is already known about the treatment

  • MK-2870

    This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating gastroesophageal cancer. It is in the early phases of research, and its safety and effectiveness are still being evaluated. The main therapeutic indication is for advanced or metastatic gastroesophageal adenocarcinoma. MK-2870 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an investigational drug, meaning it is not yet approved for general medical use.

  • Pembrolizumab

    This medication is given through an intravenous infusion and is already approved for use in various cancers, including gastroesophageal cancer. It is being studied in combination with other treatments to enhance its effectiveness. Pembrolizumab is primarily used to treat advanced cancers by blocking a protein called PD-1, which helps the immune system attack cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors, which are designed to boost the body's natural defenses against cancer.

Investigated diseases

Gastroesophageal cancer – This disease involves the development of malignant cells in the stomach and esophagus, which are parts of the digestive system. It typically begins in the cells lining the stomach or esophagus and can grow to invade deeper layers and nearby structures. As the cancer progresses, it may spread to lymph nodes and other organs, such as the liver or lungs. Symptoms often include difficulty swallowing, weight loss, and stomach pain. The progression of the disease can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509307-33-00Protocol codeMK-3475-06CEstimated enrolment96 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).