What are Clinical Trials?
New tests and treatments aren’t offered to the public as soon as they’re made. They need to be studied. Clinical trials study how safe and helpful tests and treatments are. When found to be safe and helpful, they may become tomorrow’s standard of care. Clinical trials can study many things, such as:
- New drugs not yet approved by the U.S. FDA (Food and Drug Administration)
- New uses of drugs already approved by the FDA
- New ways to give drugs, such as in pill form
- Use of alternative medicines, such as herbs and vitamins
- New tests to find and track disease
- Drugs or procedures that relieve symptoms
ClinicalTrials.gov
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
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Types of Trials
Please note, the following clinical trials are not the only clinical trials available for cholangiocarcinoma patients, the following clinical trials were submitted by the organizations conducting the trial. Please visit clinicaltrials.gov for a more comprehensive list.
It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice. We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.
It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice. We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.
Now Enrolling
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
FIRST-308
This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician.
A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer
This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CCA) that cannot be removed by surgery (unresectable) or that may have spread from where it first started.
A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)
This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
This phase I trial studies the side effects and effect of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases).
A single arm phase 2 study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma
This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.
ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
A Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma (HELIX-ICC)
This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.
TAS-120-301(FOENIX-CCA3)
FGFR2(fibroblast growth factor receptor 2) gene rearrangements, have been
identified as an early driver of oncogenic events in approximately 15% of CCA patients. Futibatinib (TAS-120),an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that inhibits FGFR1-4 isoforms, and have shown evidence of efficacy on CCA.
Gemcitabine and Cisplatin With or Without CPI-613 (Devimistat)as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Patients with advanced biliary cancer (gallbladder or cholangiocarcinoma) previously untreated with systemic chemotherapy will receive gemcitabine + cisplatin + CPI-613 (targets enzymes that are involved in cancer cell energy metabolism).
A Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
PROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).
A Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
Now Enrolling
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
In this study we test the combination of two different immunotherapy drugs (anti-CD40 and anti-PD1) in combination with chemotherapy (capecitabine and oxaliplatin (CAPOX). This study is being offered to all patients who failed first-line treatment or refused first-line therapy. The study concept and preclinical data has been supported by the CCF.
NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).
Safety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally.
A Phase 2 study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
This is a study for patients with advanced, unresectable intra or extrahepatic cholangiocarcinoma (iCCA or eCCA) with fibroblast growth factor receptor FGFR2 fusions or rearrangements. This is an open label study.
Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip Code 78229 Country United States List additional…
TS-PERIO-02 – ACTIVE, NOT RECRUITING
Study Name TS–PERIO–02 ClinicalTrials.gov Identifier (if applicable) NCT05220722 Clinical Trial Category (check all that apply) Beyond First Line Therapy Immunotherapy Other Novel Therapy Study Center Institution Name MD Anderson Cancer Center City Houston State Texas Country United States List additional Institutions (include address, phone number, and website) Rhode Island Hosptial at Brown University of Colorado…
A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel Versus Paclitaxel Alone in Adult Patients with Unresectable, Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen – COMPANION-002
Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
Brightline-2
This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.
A Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations
This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
FF-10832 encapsulates gemcitabine in a liposome, which is believed to improve the delivery of the medicine to the tumor. The current part of this study is evaluating FF-10832 in patients with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that has either spread to other parts of the body or can’t be removed completely with surgery.
Now Enrolling
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)
This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
This phase I trial studies the side effects and effect of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases).
A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel Versus Paclitaxel Alone in Adult Patients with Unresectable, Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen – COMPANION-002
Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
A single arm phase 2 study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma
This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
FF-10832 encapsulates gemcitabine in a liposome, which is believed to improve the delivery of the medicine to the tumor. The current part of this study is evaluating FF-10832 in patients with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that has either spread to other parts of the body or can’t be removed completely with surgery.
ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
All patients on this study receive the chemotherapy combination of 5-FU, leucovorin and nanoliposomal irinotecan which has shown efficacy in pancreatic cancer (and is FDA approved). In addition, this trial adds immunotherapy (nivolumab) to this chemotherapy regimen to leverage the synergism of chemo-immunotherapy.
Tree Topp
The study drug, varlitinib, is an investigational anti-tumor product, delivered in the form of tablets. The study drug has been administered as a single and combination treatment to patients with metastatic gastric cancer, gastro-esophageal tumors, breast cancer, and biliary tract cancer (BTC). Laboratory studies and animal research suggest that the study drug stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that the study drug may be effective in targeting and inhibiting (preventing) the pathways of certain proteins in cells called “HER” (human epidermal growth factor receptor). The “HER” protein is important in types of cancer such as cholangiocarcinoma (BTC), gastric cancer, breast cancer, and others. Varlitinib has shown activity in BTC. In this study, patients will receive study drug plus capecitabine, or placebo plus capecitabine. Inclusion allows all forms of BTC and there is no biomarker-based patient selection.
Now Enrolling
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
FIRST-308
This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician.
Safety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally.
Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip Code 78229 Country United States List additional…
phase 2 basket trial of ulixertinib (BVD-523) in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations (BVD-523-HCQ)
This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations. The trial will have five baskets based on disease primary: cholangiocarcinoma, pancreatic, colorectal, esophageal, and gastric adenocarcinomas.
Brightline-2
This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.
A Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations
This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam
A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients with Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
The study drug, ENV-101, acts on a protein in the body that is thought to be involved with the growth of these abnormal cells caused by a mutation of a gene, PTCH1. By blocking this process, ENV-101 may slow the progress of the disease or you may have a partial or complete response.
ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip…
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
This EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual. The solid tumors studied in this trial have either spread to other parts of the body or cannot be removed completely with surgery.
The trial will also look at what side effects happen
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
ICP-CL-00303
ICP-192 is a novel, irreversible pan-FGFR inhibitor may overcome on-target resistance to first generation FGFR inhibitors (erdafitinib, pemigatinib, rogaratinib, infigratinib, derazatinib). ICP-192 is a highly selective pan-FGFR inhibitor, and has improved safety profiles in comparison to the first generation FGFR inhibitors.
Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC)
Study Name Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC). ClinicalTrials.gov Identifier (if applicable) NCT04566133 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name National Cancer Institute Institution Address 10 Center…
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
We have identified IDH1 mutations as mediating the exclusion of immune cells in tumors. Ivosidenib is an IDH1 inhibitor. We hypothesize that blocking IDH1 will enhance cancer immunotherapy (nivolumab) in settings where immunotherapy normally doesn’t work. Approximately 10-15% of patients with cholangiocarcinomas have tumors with IDH1 mutations.
CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)
CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)
Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…
PROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Cycles will continue until disease progression or unacceptable toxicity.
Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3
This phase 2 study will enroll patients of all tumor types including cholangiocarcinomas who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the cholangiocarcinoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions
Now Enrolling
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
In this study we test the combination of two different immunotherapy drugs (anti-CD40 and anti-PD1) in combination with chemotherapy (capecitabine and oxaliplatin (CAPOX). This study is being offered to all patients who failed first-line treatment or refused first-line therapy. The study concept and preclinical data has been supported by the CCF.
NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).
A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)
This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.
TS-PERIO-02 – ACTIVE, NOT RECRUITING
Study Name TS–PERIO–02 ClinicalTrials.gov Identifier (if applicable) NCT05220722 Clinical Trial Category (check all that apply) Beyond First Line Therapy Immunotherapy Other Novel Therapy Study Center Institution Name MD Anderson Cancer Center City Houston State Texas Country United States List additional Institutions (include address, phone number, and website) Rhode Island Hosptial at Brown University of Colorado…
Brightline-2
This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.
A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel Versus Paclitaxel Alone in Adult Patients with Unresectable, Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen – COMPANION-002
Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
A single arm phase 2 study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma
This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.
ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
We have identified IDH1 mutations as mediating the exclusion of immune cells in tumors. Ivosidenib is an IDH1 inhibitor. We hypothesize that blocking IDH1 will enhance cancer immunotherapy (nivolumab) in settings where immunotherapy normally doesn’t work. Approximately 10-15% of patients with cholangiocarcinomas have tumors with IDH1 mutations.
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)
Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
All patients on this study receive the chemotherapy combination of 5-FU, leucovorin and nanoliposomal irinotecan which has shown efficacy in pancreatic cancer (and is FDA approved). In addition, this trial adds immunotherapy (nivolumab) to this chemotherapy regimen to leverage the synergism of chemo-immunotherapy.
A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients with Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers
This Phase 2 study will be conducted in conjunction with the companion harvest protocol protocol in patients with measurable disease who have lesions that can be resected or biopsied for Tumor Infiltrating Lymphocyte(TIL) growth. The Treatment Phase begins once the cells exceed the cell growth and potency requirements in the companion protocol.
A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
This is a phase II study of the combination of 2 immunotherapy drugs (durvalumab and tremelimumab) with radiation therapy in patients with hepatocellular carcinoma (HCC) with an exploratory cohort of patients with metastatic biliary tract cancer (BTC).
Now Enrolling
NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).
A single arm phase 2 study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma
This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients’ own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.
A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
This is a phase II study of the combination of 2 immunotherapy drugs (durvalumab and tremelimumab) with radiation therapy in patients with hepatocellular carcinoma (HCC) with an exploratory cohort of patients with metastatic biliary tract cancer (BTC).
Now Enrolling
NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).
Effects of Exercise and Nutritional Interventions During Platinum Chemotherapy on Neuropathy: Examining the Interoceptive Brain System and Inflammation
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. There are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN.
A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)
This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
This phase I trial studies the side effects and effect of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases).
TS-PERIO-02 – ACTIVE, NOT RECRUITING
Study Name TS–PERIO–02 ClinicalTrials.gov Identifier (if applicable) NCT05220722 Clinical Trial Category (check all that apply) Beyond First Line Therapy Immunotherapy Other Novel Therapy Study Center Institution Name MD Anderson Cancer Center City Houston State Texas Country United States List additional Institutions (include address, phone number, and website) Rhode Island Hosptial at Brown University of Colorado…
CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)
CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients’ own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.
Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer
TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.
A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients with Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers
This Phase 2 study will be conducted in conjunction with the companion harvest protocol protocol in patients with measurable disease who have lesions that can be resected or biopsied for Tumor Infiltrating Lymphocyte(TIL) growth. The Treatment Phase begins once the cells exceed the cell growth and potency requirements in the companion protocol.
Now Enrolling
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
In this study we test the combination of two different immunotherapy drugs (anti-CD40 and anti-PD1) in combination with chemotherapy (capecitabine and oxaliplatin (CAPOX). This study is being offered to all patients who failed first-line treatment or refused first-line therapy. The study concept and preclinical data has been supported by the CCF.
NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).
FIRST-308
This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician.
Effects of Exercise and Nutritional Interventions During Platinum Chemotherapy on Neuropathy: Examining the Interoceptive Brain System and Inflammation
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. There are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN.
A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer
This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CCA) that cannot be removed by surgery (unresectable) or that may have spread from where it first started.
Safety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally.
A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)
This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.
A Phase 2 study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
This is a study for patients with advanced, unresectable intra or extrahepatic cholangiocarcinoma (iCCA or eCCA) with fibroblast growth factor receptor FGFR2 fusions or rearrangements. This is an open label study.
Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip Code 78229 Country United States List additional…
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
This phase I trial studies the side effects and effect of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases).
TS-PERIO-02 – ACTIVE, NOT RECRUITING
Study Name TS–PERIO–02 ClinicalTrials.gov Identifier (if applicable) NCT05220722 Clinical Trial Category (check all that apply) Beyond First Line Therapy Immunotherapy Other Novel Therapy Study Center Institution Name MD Anderson Cancer Center City Houston State Texas Country United States List additional Institutions (include address, phone number, and website) Rhode Island Hosptial at Brown University of Colorado…
phase 2 basket trial of ulixertinib (BVD-523) in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations (BVD-523-HCQ)
This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations. The trial will have five baskets based on disease primary: cholangiocarcinoma, pancreatic, colorectal, esophageal, and gastric adenocarcinomas.
A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel Versus Paclitaxel Alone in Adult Patients with Unresectable, Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen – COMPANION-002
Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
A single arm phase 2 study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma
This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.
Brightline-2
This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.
A Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations
This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam
A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients with Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
The study drug, ENV-101, acts on a protein in the body that is thought to be involved with the growth of these abnormal cells caused by a mutation of a gene, PTCH1. By blocking this process, ENV-101 may slow the progress of the disease or you may have a partial or complete esponse.
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
FF-10832 encapsulates gemcitabine in a liposome, which is believed to improve the delivery of the medicine to the tumor. The current part of this study is evaluating FF-10832 in patients with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that has either spread to other parts of the body or can’t be removed completely with surgery.
ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip…
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
This EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual. The solid tumors studied in this trial have either spread to other parts of the body or cannot be removed completely with surgery.
The trial will also look at what side effects happen
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
ICP-CL-00303
ICP-192 is a novel, irreversible pan-FGFR inhibitor may overcome on-target resistance to first generation FGFR inhibitors (erdafitinib, pemigatinib, rogaratinib, infigratinib, derazatinib). ICP-192 is a highly selective pan-FGFR inhibitor, and has improved safety profiles in comparison to the first generation FGFR inhibitors.
Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC)
Study Name Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC). ClinicalTrials.gov Identifier (if applicable) NCT04566133 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name National Cancer Institute Institution Address 10 Center…
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
We have identified IDH1 mutations as mediating the exclusion of immune cells in tumors. Ivosidenib is an IDH1 inhibitor. We hypothesize that blocking IDH1 will enhance cancer immunotherapy (nivolumab) in settings where immunotherapy normally doesn’t work. Approximately 10-15% of patients with cholangiocarcinomas have tumors with IDH1 mutations.
CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)
CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients’ own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.
A Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma (HELIX-ICC)
This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.
TAS-120-301(FOENIX-CCA3)
FGFR2(fibroblast growth factor receptor 2) gene rearrangements, have been identified as an early driver of oncogenic events in approximately 15% of CCA patients. Futibatinib (TAS-120),an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that inhibits FGFR1-4 isoforms, and have shown evidence of efficacy on CCA.
Gemcitabine and Cisplatin With or Without CPI-613 (Devimistat)as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Patients with advanced biliary cancer (gallbladder or cholangiocarcinoma) previously untreated with systemic chemotherapy will receive gemcitabine + cisplatin + CPI-613 (targets enzymes that are involved in cancer cell energy metabolism).
Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer
TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.
A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)
Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…
A Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
All patients on this study receive the chemotherapy combination of 5-FU, leucovorin and nanoliposomal irinotecan which has shown efficacy in pancreatic cancer (and is FDA approved). In addition, this trial adds immunotherapy (nivolumab) to this chemotherapy regimen to leverage the synergism of chemo-immunotherapy.
PROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Cycles will continue until disease progression or unacceptable toxicity.
A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients with Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers
This Phase 2 study will be conducted in conjunction with the companion harvest protocol protocol in patients with measurable disease who have lesions that can be resected or biopsied for Tumor Infiltrating Lymphocyte(TIL) growth. The Treatment Phase begins once the cells exceed the cell growth and potency requirements in the companion protocol.
A Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
Tree Topp
The study drug, varlitinib, is an investigational anti-tumor product, delivered in the form of tablets. The study drug has been administered as a single and combination treatment to patients with metastatic gastric cancer, gastro-esophageal tumors, breast cancer, and biliary tract cancer (BTC). Laboratory studies and animal research suggest that the study drug stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that the study drug may be effective in targeting and inhibiting (preventing) the pathways of certain proteins in cells called “HER” (human epidermal growth factor receptor). The “HER” protein is important in types of cancer such as cholangiocarcinoma (BTC), gastric cancer, breast cancer, and others. Varlitinib has shown activity in BTC. In this study, patients will receive study drug plus capecitabine, or placebo plus capecitabine. Inclusion allows all forms of BTC and there is no biomarker-based patient selection.
A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
This is a phase II study of the combination of 2 immunotherapy drugs (durvalumab and tremelimumab) with radiation therapy in patients with hepatocellular carcinoma (HCC) with an exploratory cohort of patients with metastatic biliary tract cancer (BTC).
Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3
This phase 2 study will enroll patients of all tumor types including cholangiocarcinomas who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the cholangiocarcinoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions
Learn More About Clinical Trials
Please note, the following clinical trials are not the only clinical trials available for cholangiocarcinoma patients, the following clinical trials were submitted by the organizations conducting the trial. Please be aware not all clinical trials are available at all institutions.
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Understanding your Clinical Trial Result
“The most powerful and positive force in medicine, is that of a self-advocating patient!”
Our Chief Patient Officer, Melinda Bachini uses that statement as a signature on every email she sends. As a 15-year survivor of Cholangiocarcinoma, Melinda knows from first-hand experience, with patient education comes knowledge, understanding, and hope.
We are excited to share the newly released video, Understanding Your Clinical Trials Results. Produced in partnership with Incyte, Cholangiocarcinoma Foundation and Target Cancer Foundation, the video is an invaluable resource to help patients understand their clinical trial results.
Researchers from Fred Hutchinson Cancer Center, the American Cancer Society Cancer Action Network, and peer institutions released new findings in the Journal of Clinical Oncology showing that when all types of cancer research studies are considered, at least one in five people with cancer, or 21.9%, participate in some form of clinical research.
The study evaluated all categories of cancer studies, such as treatment trials, biorepository studies, and quality of life studies—the first time an estimate of participation in all types of cancer studies has been reported. Moreover, enrollment in cancer treatment trials was 7.1%, a notably higher participation rate than previous estimates of 2%- 3%.
The study also found that enrollment in treatment trials was over five-fold higher at National Cancer Institute-designated cancer centers than at community sites (21.6% versus 4.1%), reflecting the impact that NCI funding for staff and infrastructure has on an institution’s ability to offer trials and recruit patients.