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.

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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.

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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).

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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…

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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.

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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.

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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.

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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.

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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…

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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.

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