Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Biliary Tract Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

Durvalumab in combination with Tremelimumab

Arndt Vogel, Professor

Doerthe Vortmeyer, Doctor

Gunnar Folprecht

Ken Herrmann

Petra Buechner-Steudel

Arndt Vogel

Udo Lindig

Martin Fuchs

Jens Ricke

Salah-Eddin Al-Batran, Professor

A multicenter Phase II, randomized, prospective, open-label Trial investigating the clinical impact on combining Specific Internal Radiotherapy (SIRT) with the PD1-L Inhibitor Durvalumab and the CTLA-4 Inhibitor Tremelimumab in patients with intrahepatic Biliary Tract Cancer

IMMUWHY Phase II Clinical Trial will test the Addition of the immunotherapeutic agents Durvalumab and Tremelimumab after an initial Standard of Care SIRT in patients suffering from non-resectable intrahepatic Biliary Tract Cancer. Patients will be randomized into two experimental arms, one receiving Durvalumab only, the other one receiving Durvalumab + Tremelimumab. Clinical Outcomes will be compared vs. historical datasets.

Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Phase II Study of Immunotherapy With Durvalumab (MEDI4736) or Durvalumab and Tremelimumab, Both Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Exploratory: Predictive biomarkers that with a potential effect on Objective Response Rate, Duration of Response, Progression Free Survival and Overall Survival via blood sample collection + genetic subset analysis. The following translational research is currently planned, but may be adapted taking into account new research data: Tumors will be tested for mRNA expression of PD-1, PD-L1 and PD-L2 expression, Immune cell infiltrates (IGHM, CD3, CD8, FOXP3, CD68, CD205), Chemokines (CXCL9. CXCL10, CXCL13) and invasion markers (MMP7, MMP9)

Proportion of allocated subjects with best response of complete or partial response

Type, incidence and severity of AEs and SAEs graded according to NCI CTCAE v5.0

Time from that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the PD is objectively documented or death

Time from the date of randomization to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause

time from the date of treatment allocation to the date of death.

AstraZeneca

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Spots Global Cancer Trial Database for ibtc

Every month we try and update this database with for ibtc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibtc

Every month we try and update this database with for ibtc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibtc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.