Study of Trastuzumab Deruxtecan and Rilvegostomig for Patients with Advanced HER2-positive Biliary Tract Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as HER2-expressing Biliary Tract Cancer, which affects the bile ducts. The study will compare the effectiveness of a new treatment combination against the current standard treatment. The new treatment involves two medications: Trastuzumab Deruxtecan (also known as DS-8201a) and Rilvegostomig (also known as AZD2936). Trastuzumab Deruxtecan is a type of medication called an antibody-drug conjugate, which is designed to target and kill cancer cells. Rilvegostomig is a bispecific monoclonal antibody that targets specific proteins involved in cancer growth. The standard treatment being compared includes the medications Gemcitabine, Cisplatin, and Durvalumab.

The purpose of this study is to see if the new treatment combination can improve the overall survival of patients with this type of cancer compared to the standard treatment. Participants in the study will be randomly assigned to receive either the new treatment or the standard treatment. The study will monitor the participants over time to assess the effectiveness and safety of the treatments. The study will also look at other factors such as how long the treatments can keep the cancer from getting worse and the overall response of the cancer to the treatments.

This study is important because it aims to find better treatment options for patients with advanced biliary tract cancer, which is a challenging condition to treat. By participating in this study, researchers hope to gather valuable information that could lead to improved outcomes for patients in the future. The study is expected to continue for several years to ensure comprehensive data collection and analysis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A sample of the tumor, no older than three years, is required for analysis. This helps in confirming the presence of HER2-expressing biliary tract cancer.

2 randomization

Participants are randomly assigned to one of two groups. One group receives the investigational treatment, and the other receives the standard treatment.

The investigational treatment includes trastuzumab deruxtecan (T-DXd) and rilvegostomig. The standard treatment includes gemcitabine, cisplatin, and durvalumab.

3 treatment administration

For those receiving the investigational treatment, trastuzumab deruxtecan and rilvegostomig are administered through an intravenous infusion. The frequency and dosage are determined by the study protocol.

For those receiving the standard treatment, gemcitabine, cisplatin, and durvalumab are also administered intravenously. The specific schedule and dosage are outlined in the study protocol.

4 regular monitoring

Throughout the study, regular monitoring is conducted to assess health status and response to treatment. This includes physical exams, blood tests, and imaging studies.

Participants are required to report any side effects or changes in health to the study team promptly.

5 follow-up visits

After completing the treatment phase, follow-up visits are scheduled to monitor long-term health and any potential late effects of the treatment.

These visits may include additional tests and assessments as determined by the study protocol.

Who Can Join the Study?

  • Participants must be 18 years or older at the time of screening. There may be other age restrictions based on local rules.
  • Participants must have unresectable (cannot be removed by surgery), previously untreated, locally advanced or metastatic biliary tract cancer (BTC). If they had treatment around the time of surgery or after surgery, it is allowed if more than 6 months have passed between the end of that treatment and the diagnosis of advanced disease.
  • The cancer must be confirmed to be HER2-expressing (a specific protein found in some cancer cells) with a score of IHC 3+ or IHC 2+.
  • Participants must provide a tumor sample that is no older than 3 years.
  • There must be at least one target lesion (a specific area of cancer) that can be measured by the study doctor using a standard method called RECIST v1.1.
  • Participants must have a WHO/ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • Participants must have adequate organ and bone marrow function within 14 days before being randomly assigned to a treatment group.
  • Females who can have children must show evidence of being post-menopausal (no longer having menstrual periods) or have a negative blood pregnancy test.

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not HER2-expressing Biliary Tract Cancer cannot participate. HER2 is a protein that can affect the growth of cancer cells.
  • Patients who have received certain treatments for cancer that are not part of the study may be excluded.
  • Patients with serious heart conditions or diseases affecting the heart may not be eligible.
  • Patients with uncontrolled infections or illnesses that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with known allergies to the study drugs or similar drugs may be excluded.
  • Patients with severe liver or kidney problems may not be eligible.
  • Patients who are unable to follow the study procedures or attend study visits may 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
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Algemeen Ziekenhuis Delta Roeselare Belgium
Univerzitna Nemocnica Martin Martin Slovakia
Fakultna Nemocnica Trnava Trnava Slovakia
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hopital Prive Jean Mermoz Lyon France
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Narodny Onkologicky Ustav Bratislava Slovakia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
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
Hopital Saint Joseph Marseille France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
University Hospital Olomouc Olomouc Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hospital Paul Brousse Villejuif France
Hopital Huriez Lille France
Universitaetsklinikum Leipzig AöR Leipzig Germany
Noz Lfz Gyfuadzbns Tnxvfyofaujnp Ggfb Wiener Neustadt Austria
Cmlacu Lqzs Buzvhf Lyon France
Olbnqcyxweboio Lwfv Gzjr Linz Austria
Hwlvgknu Ufsvosoiynbsd Mlttiqr Dv Vkywogkywc Santander Spain
Uxwygpkicz Hpxpiafb Cqffvcn Cologne Germany
Fscbkshx nfvfewwmj Mfolh a Hibsxpu Prague Czechia
Elxfnvc Udfybessnqrs Molgmrp Cewuitv Rusdyzsba (yyjyefv Mtd Rotterdam The Netherlands
Nybeadtw Ideypscb Oblrokmvs Itx Meqog Scnfdjhdxywhxzriwsejacaqqauz Ilabqmep Birlcpay Cracow Poland
Kzzgeceo dga Uhphakbobodj Mfzzdydm Ahm Munich Germany
Uyrpcwvzdqviuxhzggala Wbbgdpanz Amq Wuerzburg Germany
Ujhjuvoomv Om Atxfeaa Edegem Belgium
Hphbjfxo Vpdj dfglidjz Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.05.2025
Belgium Belgium
Recruiting
30.05.2025
Czechia Czechia
Recruiting
30.05.2025
France France
Recruiting
30.05.2025
Germany Germany
Recruiting
30.05.2025
Italy Italy
Recruiting
30.05.2025
Poland Poland
Recruiting
30.05.2025
Slovakia Slovakia
Recruiting
30.05.2025
Spain Spain
Recruiting
30.05.2025
The Netherlands The Netherlands
Not yet recruiting
30.05.2025

Trial locations

Trastuzumab Deruxtecan (T-DXd) is a medication used in this trial to treat biliary tract cancer. It is a type of targeted therapy that works by attaching to a specific protein called HER2 on the surface of cancer cells. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cell, which helps to kill the cancer cells and stop them from growing.

Rilvegostomig is another medication being tested in this trial. It is designed to work alongside Trastuzumab Deruxtecan to enhance its effects. Rilvegostomig helps to boost the immune system’s ability to fight cancer by targeting specific pathways that cancer cells use to grow and spread.

Gemcitabine is a chemotherapy drug that is part of the standard treatment for biliary tract cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. This helps to slow down or stop the progression of the cancer.

Cisplatin is another chemotherapy medication used in the standard treatment. It works by damaging the DNA in cancer cells, which prevents them from multiplying. This can help to shrink tumors and slow the spread of cancer.

Durvalumab is an immunotherapy drug that is part of the standard treatment. It helps the immune system recognize and attack cancer cells more effectively. By blocking a specific protein that cancer cells use to hide from the immune system, Durvalumab allows the body’s natural defenses to better target and destroy the cancer.

Advanced HER2-expressing Biliary Tract Cancer – This is a type of cancer that occurs in the bile ducts, which are part of the digestive system. It is characterized by the overexpression of the HER2 protein, which can promote the growth of cancer cells. The disease typically progresses as the cancer cells grow and spread within the bile ducts and potentially to other parts of the body. As the cancer advances, it can cause blockages in the bile ducts, leading to symptoms such as jaundice, abdominal pain, and digestive issues. The progression of the disease can vary, with some cases advancing more rapidly than others. The focus of research is often on understanding how the HER2 protein contributes to the disease’s progression and finding ways to target it effectively.

Trial ID:
2023-508057-19-00
Protocol code:
D781PC00001
NCT ID:
NCT06467357
Trial Phase:
Therapeutic confirmatory (Phase III)

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