A multicenter, phase Ib/II, open-label study of tivozanib with durvalumab in advanced hepatocellular carcinoma (DEDUCTIVE)

Future Oncol. 2022 Dec;18(40):4465-4471. doi: 10.2217/fon-2022-0844. Epub 2023 Mar 13.

Abstract

Durvalumab, a PD-L1 inhibitor, is part of an immunotherapeutic drug class shown to have prolonged survival benefit in patients with advanced stage hepatocellular carcinoma (HCC). Tivozanib is a potent and selective VEGFR 1, 2 and 3 tyrosine kinase inhibitor. While these medications have both demonstrated single-agent activity in HCC and have been combined safely with other therapies, there is no data on their concurrent therapeutic effects. In the phase Ib DEDUCTIVE trial, the combination of tivozanib plus durvalumab is evaluated for safety and tolerability. Here, the design of and rationale for this trial in both treatment naive patients and those who progress on atezolizumab and bevacizumab for advanced or metastatic HCC are described. Clinical Trial Registration: NCT03970616.

Keywords: ctDNA; gastrectomy; gastric cancer; neoadjuvant chemotherapy.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Antibodies, Monoclonal / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Hepatocellular* / drug therapy
  • Carcinoma, Hepatocellular* / etiology
  • Clinical Trials, Phase I as Topic
  • Humans
  • Liver Neoplasms* / drug therapy
  • Liver Neoplasms* / etiology
  • Multicenter Studies as Topic

Substances

  • durvalumab
  • tivozanib
  • Antibodies, Monoclonal

Associated data

  • ClinicalTrials.gov/NCT03970616

Grants and funding