Study of Pembrolizumab with Chemotherapy for Patients with Gastric or Gastroesophageal Junction Cancer

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What is this study about?

This clinical trial is focused on studying treatments for gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma, which are types of cancer that affect the stomach and the area where the stomach meets the esophagus. The study is testing a combination of treatments to see how effective they are in improving outcomes for patients with these cancers. The main treatment being tested is pembrolizumab, also known by its code name MK-3475, which is a type of medication that helps the immune system fight cancer. Pembrolizumab is being combined with different chemotherapy drugs, including cisplatin, capecitabine, 5-fluorouracil, docetaxel, oxaliplatin, and calcium folinate (also known as leucovorin calcium). A placebo, which looks like the real treatment but does not contain the active drug, is also used for comparison.

The purpose of the study is to evaluate how well these treatments work in preventing the cancer from coming back or spreading, and to assess the overall survival of patients. The study will also look at the safety and side effects of the treatments. Participants will receive the treatments before and after surgery to remove the cancer. The study will follow participants over a period of time to monitor their health and the effectiveness of the treatments.

Throughout the study, participants will receive the treatments through intravenous infusion, which means the medication is given directly into a vein, or orally, which means taking the medication by mouth. The study aims to provide valuable information on the best treatment options for patients with gastric and GEJ adenocarcinoma, helping to improve future care and outcomes for individuals with these types of cancer.

1 initial treatment phase

The trial begins with the administration of chemotherapy combined with either pembrolizumab or a placebo. The chemotherapy regimen includes cisplatin and capecitabine (XP) or cisplatin and fluorouracil (FP).

Pembrolizumab is given as an intravenous infusion. Capecitabine is taken orally, while cisplatin and fluorouracil are administered through intravenous infusion.

This phase aims to reduce the size of the tumor before surgery.

2 surgical intervention

Following the initial treatment phase, surgery is performed to remove the tumor. The timing of the surgery is based on the response to the pre-operative chemotherapy.

3 post-surgery treatment phase

After surgery, additional chemotherapy is administered. This may again include the combination of pembrolizumab or placebo with chemotherapy (XP or FP).

The goal of this phase is to eliminate any remaining cancer cells and reduce the risk of recurrence.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects.

Follow-up visits are scheduled to evaluate overall health and the effectiveness of the treatment.

Who Can Join the Study?

The patient must have a type of cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that has not been treated before. This means the cancer is located in the stomach or where the stomach meets the esophagus.
The patient should be planning to have surgery after receiving chemotherapy, which is a treatment using drugs to kill cancer cells.
The patient must agree to provide a sample of the tumor tissue before starting the study and at the time of surgery.
The patient should have an ECOG performance status of 0 to 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.
The patient must have adequate organ function, meaning their organs are working well enough to handle the treatment.
Male patients who can have children must agree to use a reliable form of birth control during the study and for 180 days after the last dose of chemotherapy.
Female patients who can have children must agree to use a reliable form of birth control during the study and for 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is longer. Pembrolizumab is a medication used to help the immune system fight cancer.
The patient must have a life expectancy of more than 6 months, meaning they are expected to live longer than 6 months.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hopital Beaujon	Clichy	France
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Cvbebtyzj Urkzesutilldda Sroiktsip	Woluwe-Saint-Lambert	Belgium
Icihfrlk Jttme Bqzbqe	Anderlecht	Belgium
Ioqktxqb Psearsakdjeerhf Ckajce Csvzmi	Marseille	France
Nsfdp Ebmewgi Mrmkbss Cvmjtg Fxrwwjyblp	Tallin	Estonia
Vpepppei uhlbgodlaqfl lachjdha Sqgumtht kqgsqkxh Vez	Vilnius	Lithuania
Swdykkycced Pthpodqkl Zrybvk Ogmhhy Zpomosonzq Sspqosl Uylkdlqdlkpdf W Knxlttvb	Cracow	Poland
Mefwrnq Cxzilt &xxplqd Uvjaaoqdfa Oh Fpvorcbg	Freiburg Im Breisgau	Germany
Krmfciln dmy Uavrsrlcwved Mxlfrksu Adn	Munich	Germany
Cqcrux hlsdogpvyaj ubaccbufcgyxb do Lhwcq	Liege	Belgium
Afejgbv Sbuupufwx Uxateyrkykjaa Fhocco Cezkrboz	Udine	Italy
Cqdeim Hqcgsljlosj Uhxawgmoixgjh Dxoybf Gwqbsrl Slqnnmbtmzjfiyxrduyuukjobu	Namur	Belgium
Ahcingqn Znsvfqeizd Gjsmwsbjk	Kortrijk	Belgium
Fastxvwtbt Izoaimmvtj Iqrdcaco Nkkcfjhfpis Bznxb	Milan	Italy
Imddgkwm Ohadsmcxdq Vooeqz	Padua	Italy
Iqgorcks Rmamogdb Ds Cuvavy Ds Mhfnjnnksbb	Montpellier	France
Hckueez Pojuf Jszf Mhwthk	Lyon	France
Cfmxxg Dz Lidfk Cppygy Lu Covxpt Edjfyq Mxuvinl	Rennes	France
Itquq Podactxvrsv Ssk Dajjdn	San Donato Milanese	Italy
Rmlgf Amzjvnwq kzxghlix ugdlberhuoyqb scpiuvhs Snd	Riga	Latvia
Vfektlz Uqmhmzsloj Hfppbuba	Vilnius	Lithuania
Nywfepso Igqapxbx Ozsqikvwm Igq Mwqfc Skpltpsmsuopnnjjmgmjdtkgtkyg Idixxrwa Boeznbrp	Cracow	Poland
Chqqgp Hhbrzzyztht Ulnqwnzycyqqz Rmcga	Reims	France
Ciftfk Hxqkankflnt Ujurdxsgvitel Dn Pgtyvalr	Poitiers	France
Ibbhjxfa Mzsdnwnngl Mmrfscvohp	Paris	France
Whppxabmnr Sspeexu Swesowqknmkrqdb Wh Wdatlssam	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	21.09.2017
Estonia	Not recruiting	21.09.2017
France	Not recruiting	21.09.2017
Germany	Not recruiting	21.09.2017
Italy	Not recruiting	21.09.2017
Latvia	Not recruiting	21.09.2017
Lithuania	Not recruiting	21.09.2017
Poland	Not recruiting	21.09.2017

Trial locations

Investigated Drugs:

Pembrolizumab (MK-3475) is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells. In this study, it is combined with chemotherapy to treat patients with gastric and gastroesophageal junction adenocarcinoma.

Cisplatin is a chemotherapy drug used in this trial. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is used in combination with other chemotherapy drugs to enhance its effectiveness.

Capecitabine is another chemotherapy medication included in the trial. It is taken orally and is converted into 5-fluorouracil in the body, which helps to stop the growth of cancer cells.

5-Fluorouracil (5-FU) is a chemotherapy drug that interferes with the growth of cancer cells. It is often used in combination with other drugs to treat various types of cancer, including gastric cancer.

Docetaxel is a chemotherapy medication that works by preventing cancer cells from dividing. It is part of the FLOT regimen used in this trial to evaluate the safety and tolerability of pembrolizumab in combination with other drugs.

Oxaliplatin is a chemotherapy drug that is used to treat cancer by damaging the DNA of cancer cells, which stops them from growing and dividing. It is part of the FLOT regimen in this study.

Leucovorin (Calcium Folinate) is used to enhance the effectiveness of 5-fluorouracil. It helps to protect healthy cells from the harmful effects of chemotherapy and is part of the FLOT regimen in this trial.

Investigated Diseases:

Gastric and gastroesophageal junction adenocarcinoma – This is a type of cancer that begins in the glandular cells lining the stomach and the area where the stomach meets the esophagus. It typically starts in the innermost layer of the stomach wall and can grow outward through the other layers. As the disease progresses, it may spread to nearby lymph nodes and other organs. Symptoms often include difficulty swallowing, weight loss, and stomach pain. The progression can vary, with some tumors growing slowly while others may spread more rapidly. Understanding the specific behavior of the tumor is crucial for managing the disease.

Trial ID:

2023-509595-42-00

Protocol code:

MK-3475-585

NCT ID:

NCT03221426

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab with Chemotherapy for Patients with Gastric or Gastroesophageal Junction Cancer

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