Clinical trials: Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery…
- Conditions
- Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma
- Trial name
- NCT04941287
- Testing
- Atezolizumab, Biopsy, Biospecimen Collection
- Where
- 29 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Cancer Institute (NCI)
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Biliary Tract Carcinoma
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- NCT04924062
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 22 sites in China
- Volunteers
- 158 people
- Sponsor
- Merck Sharp & Dohme LLC
Biliary Tract Cancer, Biliary Tract Neoplasms
Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers
This research study is designed to see if a drug called Nivolumab is effective in treating patients with advanced refractory biliary tract cancers. Nivolumab has been approved by the U.S.
- Trial name
- NCT02829918
- Testing
- Nivolumab
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery.
- Conditions
- Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma
- Trial name
- S1310 (NCT02042443)
- Testing
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis
- Where
- 295 sites in United States
- Volunteers
- 53 people
- Sponsor
- National Cancer Institute (NCI)
Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v7
TAS-102 in Treating Advanced Biliary Tract Cancers
This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body.
- Conditions
- Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7
- Trial name
- NCT03278106
- Testing
- Laboratory Biomarker Analysis, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Mayo Clinic
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
Biliary Tract Cancer, Gallbladder Cancer
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in…
- Conditions
- Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
- Trial name
- VANGOGH (NCT00753675)
- Testing
- ZD6474, Vandetanib, Gemcitabine
- Where
- 15 sites in Italy
- Volunteers
- 174 people
- Sponsor
- Genzyme, a Sanofi Company
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors.
- Conditions
- Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Gastrointestinal Cancer, Recurrent Extrahepatic Bile Duct Cancer
- Trial name
- NCT00356889
- Testing
- erlotinib hydrochloride, bevacizumab
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- National Cancer Institute (NCI)
Carcinoma, Hepatocellular, Biliary Tract Cancer
A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases
Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement.
- Conditions
- Carcinoma, Hepatocellular, Biliary Tract Cancer, Secondary Liver Cancer, Liver Metastases
- Trial name
- NCT04338685
- Testing
- RO7119929, Tocilizumab
- Where
- 10 sites in United States, Denmark and 4 more
- Volunteers
- 55 people
- Sponsor
- Hoffmann-La Roche
Biliary Carcinoma, Gall Bladder Carcinoma
Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
- Conditions
- Biliary Carcinoma, Gall Bladder Carcinoma, Cholangiocarcinoma, Gastrointestinal Tumor
- Trial name
- NCT02631590
- Testing
- Cisplatin, Gemcitabine, Copanlisib
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body.
- Conditions
- Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8
- Trial name
- NCT03768414
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Nab-paclitaxel
- Where
- 692 sites in United States
- Volunteers
- 452 people
- Sponsor
- SWOG Cancer Research Network
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
Biliary Tract Neoplasms, Cholangiocarcinoma
Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)
Background: Biliary tract cancers are rare but they are serious. Researchers want to see if a certain drug helps the immune system fight cancer cells. The drug is called pembrolizumab.
- Conditions
- Biliary Tract Neoplasms, Cholangiocarcinoma, Bile Duct Cancer, Liver Cancer
- Trial name
- NCT03111732
- Testing
- Pembrolizumab (MK-3475), Oxaliplatin, Capecitabine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Tract Cancer
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary…
- Trial name
- NCT04677504
- Testing
- Atezolizumab, Bevacizumab, Cisplatin
- Where
- 49 sites in United States, China and 11 more
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7
Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder…
- Conditions
- Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7
- Trial name
- NCT02392637
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- M.D. Anderson Cancer Center
Thyroid Cancer, Renal Cell Carcinoma
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Conditions
- Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Trial name
- NCT04234113
- Testing
- Nanrilkefusp alfa, Pembrolizumab
- Where
- 12 sites in United States, Czechia and 2 more
- Volunteers
- 115 people
- Sponsor
- SOTIO Biotech AG
Biliary Tract Carcinoma
A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in…
- Trial name
- NCT04003896
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Milton S. Hershey Medical Center