An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG 3045), AMBITION

Jpn J Clin Oncol. 2019 Aug 1;49(8):789-792. doi: 10.1093/jjco/hyz085.

Abstract

A pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer has been started in Korea. Archival tumor samples were tested for HRD and PD-L1 status. Treatment arms will be allocated according to the test results. For HRD+ patients, we tested the synergistic effects of olaparib and other agents; treatment arms will randomly be allocated. (Arm 1: olaparib and cediranib; Arm 2: olaparib and durvalumab). For HRD- patients, we tested the role of biomarker-driven immunotherapy according to PD-L1 expression (Arm 3: durvalumab and chemotherapy in patients with high PD-L1 expression; Arm 4: durvalumab, tremelimumab, and chemotherapy in patients with low PD-L1 expression). Sixty-eight patients will be included from three Korean institutions within 1 year. The primary endpoint is the response rate according to RECIST 1.1 (6 months after treatment initiation). This trial has been registered with clinicaltrials.gov, and the registration number is NCT03699449.

Keywords: biomarker; ovarian cancer; platinum-resistant; targeted therapy; umbrella study.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Biomarkers, Tumor* / metabolism
  • Drug Resistance, Neoplasm*
  • Female
  • Humans
  • Molecular Targeted Therapy*
  • Neoplasm Recurrence, Local* / drug therapy
  • Organoplatinum Compounds* / therapeutic use
  • Ovarian Neoplasms* / drug therapy
  • Ovarian Neoplasms* / pathology
  • Pilot Projects
  • Randomized Controlled Trials as Topic
  • Republic of Korea

Substances

  • Biomarkers, Tumor
  • Organoplatinum Compounds

Associated data

  • ClinicalTrials.gov/NCT03699449