J Gynecol Oncol.  2019 Nov;30(6):e112. 10.3802/jgo.2019.30.e112.

A phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in advanced-stage ovarian cancer: a Korean Gynecologic Oncology Group Study (KGOG 3046), TRU-D

Affiliations
  • 1Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.
  • 2Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.
  • 3Division of Tumor Immunology and Center for Clinical Trial, Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
  • 4Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. bgkim@skku.edu
  • 5R connect, Seoul, Korea.

Abstract

BACKGROUND
A single-arm phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in the treatment of advanced-stage ovarian cancer has begun in Korea. We hypothesized that adding durvalumab (anti-programmed death-ligand 1 antibody) and tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4 antibody) to chemotherapy in treating this cancer can increase progression-free survival (PFS) with minimal effects on safety.
METHODS
During treatment, serial biopsies will be performed on pre-treatment, at interval debulking surgery and progression to identify immune biomarkers and changes in the tumor microenvironment. Patients with histologically confirmed stage IIIC/IV epithelial ovarian cancer are offered durvalumab, tremelimumab plus chemotherapy for neoadjuvant chemotherapy and durvalumab plus chemotherapy for adjuvant chemotherapy. Twenty-four patients will be included from four Korean institutions within 1 year. The primary endpoint is a 12-month PFS rate. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03899610

Keyword

Epithelial Ovarian Cancer; Chemotherapy; Durvalumab; Tremelimumab; Immunotherapy

MeSH Terms

Biomarkers
Biopsy
Chemotherapy, Adjuvant
Disease-Free Survival
Drug Therapy*
Humans
Immunotherapy
Korea
Ovarian Neoplasms*
Tumor Microenvironment
Biomarkers
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