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Clinical Trials > Immunotherapy

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

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)

This is a Phase III Study of Durvalumab (Immunotherapy) in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers. Chemotherapy (Gemcitabine plus Cisplatin) is the standard of care for advanced biliary tract cancer.

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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.

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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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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).

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A Phase 1 Study of CDX-1140, a Fully Human Agonist Anti-CD40 Monoclonal Antibody, in Patients With Advanced Solid Tumors

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 and to further evaluate its safety, tolerability, and efficacy in expansion cohorts once the MTD is determined.

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A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

This is a trial of combining a HDAC inhibitor and a PD1 inhibitor (immunotherapy drug) to make cholangiocarcinoma more sensitive to immunotherapy. This is based on laboratory data that shows HDAC inhibitors can make tumors more sensitive to immunotherapy.

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A Randomized Phase II Study of Nivolumab in Combination with Gemcitabine/Cisplatin or Ipilimumab as First Line Therapy for Patients with Advanced Unresectable Biliary Tract Cancer

The study is investigating the role of immunotherapy in combination with chemotherapy or dual immunotherapy as first line therapy for unresectable or metastatic patients with biliary tract cancer.

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Immunotherapy of Cholangiocarcinoma

Earlier version of immunotherapy, which was designed for patients with hepatocellular carcinoma (HCC) has shown limited efficacy in patients with cholangiocarcinoma (CCA). The decline in levels of CA19.9 marker common in CCA correlated with tumor shrinkage.

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A Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers

The purpose of this study is to test the efficacy of the immunotherapy agent nivolumab in patients with advanced, refractory biliary cancers (intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer). Patients will be evaluated for progression-free survival, overall survival and response rate.

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