Twenty-Five US-Based Clinical Trials of Note in CCA That Are Active and Recruiting

March 2024, Vol 5, No 1

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.

  • Study of tinengotinib vs. physician's choice a treatment of subjects with FGFR-altered in cholangiocarcinoma (FIRST-308). ClinicalTrials.gov identifier: NCT05948475. Updated February 26, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT05948475
  • Neoadjuvant therapy of HAIC (GEMOX) combined with adebrelimab and lenvatinib for resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors: NEO-ERA-01 study. ClinicalTrials.gov identifier: NCT06208462. Updated January 17, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06208462
  • Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab (TURANDORELA). Updated February 29, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06237920
  • Sacituzumab govitecan for the treatment for patients with locally advanced, recurrent, or metastatic cholangiocarcinoma. ClinicalTrials.gov identifier: NCT06178588. Updated February 22, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06178588
  • 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. ClinicalTrials.gov identifier: NCT05223816. Updated March 7, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT05223816
  • Rilvegostomig + chemotherapy as adjuvant therapy for biliary tract cancer after resection (ARTEMIDE-Biliary01). ClinicalTrials.gov identifier: NCT06109779. Updated February 26, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06109779
  • Study of gemcitabine, cisplatin, AB680 and AB122 during first line treatment of advanced biliary tract cancers (QUIC). ClinicalTrials.gov identifier: NCT06048133. Updated March 15, 2024. Access March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06048133
  • Efficacy and Safety of zanidatamab with standard-of-care therapy against standard-of-care therapy for advanced HER2-positive biliary tract cancer. ClinicalTrials.gov identifier: NCT06282575. Updated February 28, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06282575
  • Pembrolizumab with or without lenvatinib or chemotherapy in first-line treatment of advanced biliary tract cancer. ClinicalTrials.gov identifier: NCT0623047. Updated February 28, 2024. Accessed March 15, 2024. classic.clinicaltrials.gov/ct2/show/NCT06230471
  • 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.
  • M9241 in combination with hepatic artery infusion pump (haip) and systemic therapy for subjects with metastatic colorectal cancer or intrahepatic cholangiocarcinoma: nct05286814.
  • Gemcitabine and oxaliplatin chemotherapy with or without a floxuridine and dexamethasone pump in people with cholangiocarcinoma that cannot be removed with surgery: nct04891289.
  • 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.
  • A study to evaluate the efficacy and safety of pemigatinib versus chemotherapy in unresectable or metastatic cholangiocarcinoma (fight-302): nct03656536.
  • Lyt-200 alone and in combination with chemotherapy or anti-pd-1 in patients with metastatic solid tumors: NCT04666688.

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