Study of Pembrolizumab, Trastuzumab, and Chemotherapy for Patients with HER2 Positive Advanced Stomach or Gastroesophageal Junction Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. This is a form of cancer that affects the stomach or the area where the stomach meets the esophagus. The study is investigating the effectiveness of a treatment combination that includes the drug pembrolizumab, also known by its code name MK-3475, along with trastuzumab and chemotherapy. Chemotherapy involves using drugs to kill cancer cells or stop them from growing. The study also includes a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to compare how well patients do with the different treatment combinations. Participants will receive either the combination of pembrolizumab, trastuzumab, and chemotherapy or trastuzumab, chemotherapy, and a placebo. The study will monitor how long patients live without the cancer getting worse and their overall survival. The treatment will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. Some of the chemotherapy drugs used in this study include oxaliplatin, capecitabine, cisplatin, and fluorouracil.

Participants in the study will be closely monitored for any side effects or adverse events, which are any unwanted effects of the treatment. The study aims to provide valuable information on the effectiveness and safety of the treatment combinations for patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. The study is expected to last for a period of time, during which participants will receive regular assessments to track their progress and response to the treatment.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be asked to provide consent to participate.

You will undergo initial assessments to confirm eligibility, including tests to verify the diagnosis of HER2 positive gastric or gastroesophageal junction adenocarcinoma.

2 treatment initiation

You will begin treatment with a combination of medications. The treatment includes trastuzumab and chemotherapy drugs such as oxaliplatin, capecitabine, cisplatin, and fluorouracil.

You will receive trastuzumab and oxaliplatin through an intravenous infusion, which means the medication is delivered directly into your bloodstream through a vein.

The chemotherapy drug capecitabine is taken orally, meaning you will swallow it in pill form.

3 randomized treatment

You will be randomly assigned to receive either pembrolizumab or a placebo. Pembrolizumab is administered through an intravenous infusion.

A placebo is a substance with no active medication, used to compare the effects of the actual drug.

4 ongoing treatment

You will continue to receive the assigned treatment regimen at regular intervals as determined by the study protocol.

The duration and frequency of each medication will be explained to you by the study team.

5 monitoring and assessments

Throughout the trial, you will undergo regular assessments to monitor your health and the effectiveness of the treatment.

These assessments may include physical exams, blood tests, and imaging studies to evaluate the progression of the disease.

6 completion of the trial

At the end of the trial, you will have a final assessment to determine the overall impact of the treatment.

You will be informed about the results of the study and any potential next steps regarding your treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma that is HER2-positive. This means the cancer has a specific protein called HER2 on its surface.
  • The cancer must be locally advanced, meaning it has spread to nearby areas, or metastatic, meaning it has spread to other parts of the body.
  • Must have measurable disease as determined by specific medical criteria used by the study doctor.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use approved birth control methods.
  • Must have a performance status of 0 or 1 on the ECOG Performance Scale, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have a life expectancy of more than 6 months.
  • Must have adequate organ function, meaning the organs are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides gastric or gastroesophageal junction (GEJ) adenocarcinoma cannot participate.
  • Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma or in situ cervical cancer, are excluded.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with known allergies to the study drugs or similar drugs are not eligible.
  • Patients who have received another investigational drug within the last 4 weeks are excluded.
  • Patients with a history of drug or alcohol abuse within the last 6 months cannot join the study.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire Rouen Rouen France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero Universitaria Di Modena Modena Italy
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ Bielsko-Biala Poland
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Cliniche Gavazzeni S.p.A. Bergamo Italy
Beaumont Hospital Dublin Ireland
Cglbgr Lqnz Bintjw Lyon France
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Dgmgikclcvjp Cesnhyj Ohovqbiss Ptinkpkbvdry I Hiudggfzprx Wroclaw Poland
Stvsaltv Pzlfkpcxr Sqs z ocvm Gdynia Poland
Pwejizsvzgk Llnpwkat &ftyxmpggorokktdrmxt Rjmur Kplbvgjzbbu Konin Poland
Bazmrhcs Ubfjntbgra Hhmqrphp Coshri Besançon France
Ndkqxiec Igtikqtr Ozgajvlgx Idk Mksjj Sovckvjmdqvtkueetzxrpxvpdmoe Isozscxw Bbrtqyyw Cracow Poland
Hksqjaqn Uqqtyswqkgpxm Hphndjiy Thest y Pkdwgg Ibakykry Csteay deqtniakiojefarao (idti Badalona Spain
Hlvarpes Vbiw drvxpqzs Barcelona Spain
Cdftsh Onpuz Lltjraq Lille France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
12.10.2018
Germany Germany
Not recruiting
12.10.2018
Ireland Ireland
Not recruiting
12.10.2018
Italy Italy
Not recruiting
12.10.2018
Poland Poland
Not recruiting
12.10.2018
Spain Spain
Not recruiting
12.10.2018

Trial locations

Trastuzumab is a medication used in this trial to treat a type of cancer known as HER2 positive advanced gastric or gastroesophageal junction adenocarcinoma. It works by targeting and blocking the function of a protein called HER2, which can promote the growth of cancer cells. By blocking this protein, trastuzumab helps to slow down or stop the growth of the cancer.

Pembrolizumab is another medication used in this trial. It is an immunotherapy drug that helps the body’s immune system fight cancer. Pembrolizumab works by blocking a specific protein on the surface of immune cells, which allows these cells to better recognize and attack cancer cells. This can help to slow down the progression of the cancer and improve survival rates.

Gastric or gastroesophageal junction adenocarcinoma – This is a type of cancer that forms in the glandular cells lining the stomach or the area where the stomach meets the esophagus. It begins when these cells start to grow uncontrollably, forming a tumor. As the disease progresses, the tumor can invade deeper layers of the stomach wall and spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, weight loss, and stomach pain. The disease can also cause bleeding in the stomach, leading to anemia. Over time, it may metastasize to distant parts of the body, affecting overall health and function.

Trial ID:
2023-508253-98-00
Protocol code:
MK-3475-811
NCT ID:
NCT03615326
Trial Phase:
Therapeutic confirmatory (Phase III)

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