Study on MK-2870, Pembrolizumab, and Chemotherapy for Patients with Advanced Gastroesophageal Cancer

1 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Di Pisa Pisa Italy
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Ivpseyqu Rohcgolsv Pmt Lm Swhfql Djd Tuzrde Dtgg Aysspyd Ivvj Stxtlo Meldola Italy
Uwslxurculotkmlxpxppg Dtraonedqfu Azb Duesseldorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2024
Germany Germany
Recruiting
01.07.2024
Italy Italy
Recruiting
01.07.2024
Norway Norway
Recruiting
01.07.2024

Trial locations

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.

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 ID:
2023-509307-33-00
Protocol code:
MK-3475-06C
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Evaluation of Safety and Efficacy of MK-2870 and Paclitaxel in Second-Line Treatment of Advanced/Metastatic Gastroesophageal Adenocarcinoma

    Recruiting

    1 1 1 1
    France Germany Italy Norway
  • A Study of Zanidatamab for Patients with Previously Treated HER2-Expressing Solid Tumors

    Recruiting

    2 1 1
    Investigated drugs:
    Spain