Encourage Your Patients to Participate! Actively Recruiting US-Based Clinical Trials in CCA September 2023

September 2023, Vol 4, No 3

26 US-Based Clinical Trials of Note in CCA

That Are Active and Recruiting

Systemic Medical Therapy/Phase 2-3

Clinical trial recruitment and retention remain challenging in the quest to bring innovative medicines to patients. In oncology, therapies continue to evolve, yet researchers are frequently faced with low trial participation, particularly among minority groups.

This new CCA News feature aims to provide an ongoing list of US-based clinical trials that are actively recruiting for clinicians to use in discussions with their patients to encourage enrollment. The highlighted trials are new to this issue. Clinical trial identifiers can be found on www.ClinicalTrials.gov.

  • Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio: NCT05655949
  • An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma: NCT05223816
  • Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4): NCT05727176
  • M9241 in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer or Intrahepatic Cholangiocarcinoma: NCT05286814
  • Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers: NCT04645160
  • Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial): NCT05564403
  • Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer/Biliary Tract Cancer: NCT05775159
  • Brightline-2: A Study to Test Whether BI 907828 Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder: NCT05512377
  • mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma: NCT04251715
  • M9241 in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer or Intrahepatic Cholangiocarcinoma: NCT05286814
  • Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations: NCT04233567
  • Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery: NCT04891289
  • XmAb20717 in Advanced Biliary Tract Cancers: NCT05297903
  • Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC): NCT04057365
  • Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer: NCT03482102
  • NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer: NCT04005339
  • Olaparib in Treating Patients with Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations: NCT04042831
  • A Study of CTX-009 in Combination with Paclitaxel in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers: NCT05506943
  • Durvalumab and Tremelimumab with Platinum-Based Chemotherapy in Intrahepatic Cholangiocarcinoma: NCT04989218
  • A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (FIGHT-302): NCT03656536
  • Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma: NCT04919642
  • Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations: NCT03212274
  • REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors: NCT04526106
  • Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04): NCT04203160
  • Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types: NCT05000294
  • A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer: NCT03929666

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