Study of MK-2870 for Patients with Advanced or Metastatic Stomach Cancer, Comparing Its Effects to a Drug Combination

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment called MK-2870 for people with advanced or metastatic stomach cancer, specifically gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. These are types of cancers that affect the stomach and the area where the stomach meets the esophagus. The study aims to compare MK-2870 with other treatments chosen by doctors to see which is more effective in improving the overall survival of patients.

Participants in the study will receive either MK-2870 or a treatment selected by their physician. The study will also involve other medications such as trifluridine and tipiracil, which are combined in one treatment, as well as paclitaxel, docetaxel, and irinotecan hydrochloride. These medications are commonly used in cancer treatment and will be administered through intravenous infusion, which means they are given directly into a vein. Some participants may also receive medications like H2-receptor antagonists, glucocorticoids, antihistamines, and pain relievers like paracetamol and codeine phosphate to help manage symptoms or side effects.

The study will take place over a period of time, with regular check-ups and assessments to monitor the participants’ health and the effectiveness of the treatment. The main goal is to determine which treatment helps patients live longer and to understand any side effects that may occur. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, a diagnosis of advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma must be confirmed.

A tumor tissue sample is required for determining the status of a specific antigen before randomization.

2 randomization

Participants are randomly assigned to receive either the study drug MK-2870 or a treatment chosen by the physician.

The choice of treatment is based on previous therapies and the participant’s health status.

3 treatment administration

If assigned to MK-2870, the medication is administered according to the study protocol.

If assigned to the physician’s choice, possible treatments include trifluridine-tipiracil (oral use), paclitaxel (intravenous infusion), docetaxel (intravenous infusion), or irinotecan (intravenous infusion).

The specific dosage and frequency depend on the treatment selected and the participant’s condition.

4 monitoring and assessments

Regular monitoring is conducted to assess the effectiveness and safety of the treatment.

Assessments include measuring disease progression, response rate, and any adverse events experienced.

5 completion of treatment

The treatment continues until the study’s end date or until the participant experiences significant disease progression or adverse effects.

The estimated end date for the study is May 5, 2028.

Who Can Join the Study?

The patient must have a confirmed diagnosis of advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. Advanced means the cancer has spread significantly, and metastatic means it has spread to other parts of the body.
The patient must have received and shown progression after at least two previous treatments with chemotherapy or immunotherapy. Chemotherapy uses drugs to kill cancer cells, and immunotherapy helps the immune system fight cancer.
If the cancer is HER2+ (human epidermal growth factor receptor 2 positive), the patient must have previously received a treatment called trastuzumab, if it was available and appropriate. HER2+ is a protein that can promote the growth of cancer cells.
The patient must have adequate organ function, meaning their organs are working well enough to handle the treatment.
The patient must provide a sample of their tumor tissue to check for TROP2 status. TROP2 is a protein that may be present on the surface of cancer cells.
The patient must have measurable disease according to specific criteria called RECIST 1.1, which are used to assess how well the cancer responds to treatment.
The patient must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
If the patient may receive a medication called trifluridine-tipiracil, they must be able to swallow oral medication.

Who Cannot Join the Study?

Patients with any other type of cancer that is not the specific type being studied cannot participate.
Patients who have had a different cancer in the past, unless it was successfully treated and has not come back, are excluded.
Patients who have serious heart problems, such as heart failure or a recent heart attack, cannot join the study.
Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication, are not eligible.
Patients with active infections that require treatment with antibiotics or other medications are excluded.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a known allergy to the study medication or any of its ingredients are not allowed to join.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
Patients who have a mental health condition that makes it difficult for them to understand or follow the study instructions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universita Cattolica Del Sacro Cuore	Rome	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Odense University Hospital	Odense	Denmark
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universita’ Di Pisa	Pisa	Italy
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Clucad Lkan Bapwln	Lyon	France
Hkejvtdb Uvpjyuoioqscf Mxdalcb Do Vimjfugqfy	Santander	Spain
Cvqkruewe Ulfbiwmurskxuw Sxhwqhyrw	Woluwe-Saint-Lambert	Belgium
Nempxlif Iysvdmoz Ohjaccobk Iik Mmfrg Svngkqzpddlxzchhdrycneiawjzz Iwckftkd Blkhkiew	Cracow	Poland
Hgbfezvs Vysk deesmolw	Barcelona	Spain
Chvqau Ogble Llnwmul	Lille	France
Hjwrchey Urpcjfisoszei dm A Cmfabx	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.05.2024
Denmark	Not recruiting	01.05.2024
France	Not recruiting	01.05.2024
Germany	Not recruiting	01.05.2024
Italy	Not recruiting	01.05.2024
Poland	Not recruiting	01.05.2024
Spain	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

MK-2870 is an investigational medication being studied for its effectiveness and safety in treating advanced or metastatic gastroesophageal adenocarcinoma. This type of cancer affects the stomach and the area where the stomach meets the esophagus. The trial aims to see how well MK-2870 works compared to other treatments chosen by doctors for patients who have already tried at least two other therapies.

Gastric Adenocarcinoma – This is a type of cancer that begins in the glandular cells of the stomach lining. It often starts in the innermost layer of the stomach and can grow deeper into the stomach wall. As it progresses, it may spread to nearby lymph nodes and other organs. Symptoms can include stomach pain, weight loss, and nausea. The disease can be aggressive, with potential to metastasize to distant parts of the body.

Gastroesophageal Junction Adenocarcinoma – This cancer occurs where the esophagus meets the stomach. It originates in the glandular cells that produce mucus and other fluids. The disease can cause difficulty swallowing, chest pain, and unintended weight loss. As it advances, it may invade nearby tissues and spread to other areas. The progression can lead to complications affecting digestion and nutrition.

Esophageal Adenocarcinoma – This cancer forms in the esophagus, typically in the lower part near the stomach. It arises from glandular cells that line the esophagus and produce mucus. Symptoms often include trouble swallowing, chest discomfort, and regurgitation. The disease can grow through the esophageal wall and spread to lymph nodes and other organs. Its progression can significantly impact eating and overall health.

Trial ID:

2023-505423-31-00

Protocol code:

MK-2870-015

NCT ID:

NCT06356311

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of MK-2870 for Patients with Advanced or Metastatic Stomach Cancer, Comparing Its Effects to a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?