A study of pumitamig and a drug combination versus nivolumab and a drug combination for patients with untreated advanced or metastatic stomach or esophageal cancer

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What is this study about?

This study focuses on patients with previously untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma. This refers to a type of cancer found in the stomach, the area where the esophagus meets the stomach, or the lower part of the esophagus that has spread to other parts of the body. The purpose of the study is to compare the effectiveness and safety of different treatment combinations for this cancer.

Participants may receive a combination of the study drug pumitamig (also referred to as BNT327) and chemotherapy. The chemotherapy medications involved include oxaliplatin, fluorouracil, and capecitabine, sometimes used alongside calcium folinate. In the first part of the study, two different doses of pumitamig are tested to see which one works best. In the second part, the more effective dose is compared to a standard treatment consisting of nivolumab and chemotherapy.

The study is conducted in stages. Initially, the goal is to determine which dose of the new medicine is most effective at controlling tumor growth while minimizing side effects. Following this, the selected dose is evaluated to see if it can extend progression-free survival, which is the length of time a patient lives with the disease without it getting worse, and overall survival, which is the total length of time a patient remains alive.

Who Can Join the Study?

  • You have not yet received systemic treatment, which means medicine that travels through your entire body (like chemotherapy) to treat your cancer.
  • Your cancer is advanced or metastatic, meaning the cancer has grown or spread beyond where it first started.
  • Your cancer type is gastric cancer (stomach cancer), gastroesophageal junction cancer (where the esophagus meets the stomach), or esophageal adenocarcinoma (a type of cancer starting in the esophagus).
  • The cancer has been confirmed by a doctor using a biopsy (taking a small sample of tissue), endoscopy (using a tiny camera to look inside the body), or imaging (such as a scan).
  • Your cancer tests show PD-L1 levels of 1 or higher, which is a specific protein found on some cancer cells.
  • Your cancer is HER2-negative, meaning the cancer cells do not have high amounts of a specific protein that helps cancer grow.
  • Your cancer is measurable, which means a doctor can clearly see the size and location of the tumors on medical scans using standard measurement rules called RECIST.
  • You can be either male or female.
  • You must be within the age range specified for this study.

Who Cannot Join the Study?

  • You cannot participate if you have cancer that has spread to the central nervous system, which is the part of the body that includes the brain and spinal cord, unless it has been properly treated and your nerve functions have returned to normal for at least 2 weeks.
  • You cannot participate if you are taking corticosteroids, which are medicines used to reduce swelling or inflammation, unless you have stopped them or your dose has been stable or decreasing at a low level for at least 2 weeks.
  • You cannot participate if you have significant heart disease, such as a heart attack (damage to the heart muscle due to lack of blood), unstable angina (chest pain that occurs unpredictably or at rest), arterial thrombosis (a blood clot in an artery), or a stroke (a sudden interruption of blood flow to the brain) within the last 6 months.
  • You cannot participate if you have uncontrolled high blood pressure, meaning your blood pressure readings remain high despite taking the best possible medicine.
  • You cannot participate if you have congenital long QT syndrome, which is an electrical problem in the heart that can cause irregular heartbeats that you are born with.
  • You cannot participate if you have major blood clotting disorders, such as hemophilia, which is a condition where the blood does not clot normally.
  • You cannot participate if you have a history of deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot that travels to the lungs), or other significant blood clots within the last 3 months, unless you have been fully treated or are taking medicine to prevent clots.
  • You cannot participate if you have had an abdominal fistula (an abnormal connection or tunnel between organs in the abdomen) or a gastrointestinal perforation (a hole made in the wall of the stomach or intestines) within the last 6 months.
  • You cannot participate if you have had major surgery, an open biopsy (the removal of tissue through a large incision for testing), or a significant injury within the last 28 days.
  • You cannot participate if you are expected to need major surgery while you are taking part in the study.

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
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital General Universitario Gregorio Maranon Madrid Spain
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Radiotherapy Center Cluj S.R.L. Floresti Romania
Mazowiecki Szpital Onkologiczny Sp. z o.o. Wieliszew Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej Jelenia Gora Poland
Chzmjr Lolm Brfsvw Lyon France
Hujxodpk Uguvspjsxdous Mrtnbkp Dn Vhpcwsfbuz Santander Spain
Aphxnusorf Pjgcqdup Hohpeuud Df Mggwexitc Marseille France
Azdhswf Occisvtodyb Ugqdseszknxis Cjdkddqwdpgt Datkx Suhted E Dcbey Sregdjq Df Tzresw Turin Italy
Nmyfando Ibpfawtf Orieexdqc Igr Mgtnu Sscwlskgtluzxmimokucdzehfvyb Ijfiwnbw Btmifojw Cracow Poland
Fqnqjeefh Puxv Lz Iffeyvmnjsedw Bdwkntqje Drd Hmypbpde Ucvvqcsafsbcn Lt Pkl Madrid Spain

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
09.03.2026
Germany Germany
Recruiting
09.03.2026
Italy Italy
Not yet recruiting
09.03.2026
Poland Poland
Recruiting
09.03.2026
Romania Romania
Recruiting
09.03.2026
Spain Spain
Recruiting
09.03.2026

Trial locations

Calcium folinate is a medication used in this trial to support the body during treatment.

Nivolumab is a type of immunotherapy used as a comparison treatment to help the immune system recognize and fight cancer cells.

Pumitamig is an investigational medicine being tested in combination with chemotherapy to see how well it helps control cancer growth.

Oxaliplatin is a chemotherapy drug used to help kill cancer cells.

Fluorouracil is a chemotherapy drug used to help kill cancer cells.

Capecitabine is a chemotherapy medication taken by mouth to help treat cancer.

Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus – This is a type of cancer that begins in the glandular cells that line the inner surfaces of the stomach, the area where the esophagus meets the stomach, or the esophagus. The disease occurs when these cells grow uncontrollably and form abnormal masses. In advanced or metastatic stages, the cancer has spread from its original location to other parts of the body. As it progresses, the tumor cells continue to multiply and may invade nearby tissues or travel through the blood and lymphatic systems.

Trial ID:
2025-523263-37-00
Protocol code:
CA2660004
NCT ID:
NCT07221149
Trial Phase:
Therapeutic use (Phase IV)

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