A study of rilvegostomig, cisplatin, and gemcitabine compared to durvalumab and a drug combination for adults with advanced biliary tract cancer

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What is this study about?

This study focuses on individuals with advanced Biliary Tract Cancer, which is a type of cancer that develops in the bile ducts, the tubes that carry bile from the liver to the gallbladder. The purpose of the study is to compare the effectiveness and safety of two different treatment approaches. One group will receive rilvegostomig combined with chemotherapy, while another group will receive durvalumab combined with chemotherapy. Chemotherapy refers to the use of powerful medicines to kill fast-growing cancer cells.

The treatment involves medications administered through an intravenous line, which means the medicine is delivered directly into a vein. Some participants may also be taking infliximab or mycophenolate mofetil as part of their ongoing background care. The study also involves the use of other medicines such as gemcitabine or cisplatin to compare how different drug combinations affect patients with certain levels of the PD-L1 protein, a substance found on some cancer cells that helps the immune system identify them.

Who Can Join the Study?

  • You must have a confirmed type of cancer called adenocarcinoma, which is a cancer that starts in the glands, located in the biliary tract (the system of tubes that carries bile). This includes cancers of the bile ducts inside or outside the liver, or cancer of the gallbladder.
  • The cancer must be unresectable, meaning it cannot be removed by surgery, and it must be either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body).
  • You must have not yet received treatment for this advanced stage of the cancer.
  • Your PD-L1 status must be known. PD-L1 is a protein found on certain cells that helps the cancer hide from the immune system. This must be tested using a proper sample of your tumor in a central laboratory.
  • The cancer must be measurable, meaning doctors can clearly see and track the size of the tumors using imaging tests like a CT scan or MRI.
  • You must have a good ECOG Performance Status of 0 or 1. This is a scale used by doctors to measure how well you can perform daily activities; a score of 0 or 1 means you are still quite active and able to function well.
  • You must have had stable health and no significant decline in your ability to function over the 2 weeks before starting the study.
  • Your bone marrow (the part of your body that makes blood cells) and your organ function (how well your vital organs like the liver or kidneys work) must be healthy and adequate.

Who Cannot Join the Study?

  • Having ampullary carcinoma, which is a type of cancer that starts in the area where the bile duct meets the small intestine.
  • Having already received any systemic therapy, which means medicine that travels through the entire body, to treat advanced or spreading biliary tract cancer that cannot be removed by surgery.
  • Having previously used any treatment that targets the immune-regulatory receptors or mechanisms, which refers to medicines that change how the body’s immune system (the system that fights germs and disease) works.
  • Taking any other cancer treatments at the same time, such as chemotherapy (drugs used to kill cancer cells), radiotherapy (using radiation to treat cancer), immunotherapy (treatments that help the immune system fight cancer), biologic therapies, or hormonal therapy, other than the specific medicines being studied in this trial.
  • Having an active or past autoimmune or inflammatory disorder, which are conditions where the body’s immune system attacks its own healthy cells, that requires long-term use of steroids or other immunosuppressive treatments (medicines that lower the activity of the immune system).
  • Having active or ongoing interstitial lung disease or pneumonitis, which are conditions involving inflammation or scarring in the lungs.
  • Having serious, ongoing gastrointestinal conditions (problems with the stomach or intestines) that cause diarrhea.
  • Having an active non-infectious skin disease, such as a rash, urticaria (hives), dermatitis (skin inflammation), ulceration (open sores), or psoriasis (a condition causing red, itchy, scaly skin patches), that requires medicine to be taken throughout the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
IRCCS Humanitas Research Hospital Rozzano Italy
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre hospitalier universitaire de Liege Liege Belgium
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Algemeen Ziekenhuis Delta Roeselare Belgium
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Ospedale San Raffaele S.r.l. Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Muenchen Klinik gGmbH Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Ujyx Cvyoqmzt Tfxekc Sxu z oxja Lodz Poland
Umpkusvrltuvrcujblzwf Etwdw Avg Essen Germany
Undfhctzmzvv Mvfsecz Cpubwoo Gaeuvxzxx Groningen The Netherlands
Hksgmbcs Uwhcvgmjlrkbs Mqsyzvq Di Vrlnsasptb Santander Spain
Ioomgrvg Cyoetr Dmkfpcvzakwltkqao L'hospitalet De Llobregat Spain
Ejqoncuydmfbesnh Bpxzqb Bmmnvvpjfbu Berlin Germany
Agclyjfkw Upg Amsterdam The Netherlands
Avgjydhawp Pqtpbrgi Hmpqfapi Dw Mxfndsbro Marseille France
Nonzshfm Ikzbmtmt Oxctjjptd Iys Momrx Szeqgiqjydjtzvoydhsddjjxtyge Ippkbshb Brlmkpya Cracow Poland
Gnfhmr Utrwtakgnu Fkjqnennc Frankfurt Germany
Ukskftpwfl Oh Aslopqt Edegem Belgium
Uogobnbstirrdlifghxzr Dyvibitmqwf Arx Duesseldorf Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
31.12.2025
France France
Recruiting
31.12.2025
Germany Germany
Not yet recruiting
31.12.2025
Italy Italy
Recruiting
31.12.2025
Poland Poland
Not yet recruiting
31.12.2025
Spain Spain
Recruiting
31.12.2025
The Netherlands The Netherlands
Recruiting
31.12.2025

Trial locations

Rilvegostomig is the experimental treatment being tested in this study. It is given through an intravenous infusion and is intended to work alongside chemotherapy to treat advanced biliary tract cancer.

Durvalumab is a medication used as a comparison in this trial. It is an immunotherapy delivered through an intravenous infusion that helps the body’s immune system recognize and attack cancer cells, and it is administered in combination with chemotherapy.

Gemcitabine is a type of chemotherapy medication given through an intravenous infusion to help kill cancer cells.

Cisplatin is a chemotherapy medication administered through an intravenous infusion used to treat cancer by interfering with the growth of cancer cells.

Infliximab is a medication used as background therapy, which is typically used to manage inflammation or immune responses, and is given through an intravenous infusion.

Mycophenolate mofetil is a medication used as background therapy that works by suppressing the immune system, and it is taken orally.

Investigated diseases:

Biliary Tract Cancer – This is a type of cancer that starts in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can develop in the ducts inside the liver or in the ducts outside the liver. The disease typically progresses as abnormal cells grow uncontrollably within these channels. As the cancer grows, it can block the flow of bile through the body. This progression can lead to changes in how the liver functions and how the digestive system processes nutrients.

Trial ID:
2025-523085-24-00
Protocol code:
D702NC00001
NCT ID:
NCT07221253
Trial Phase:
Therapeutic confirmatory (Phase III)

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