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
- Author:
Jung Yun LEE
1
;
Jae Weon KIM
;
Myong Cheol LIM
;
Sunghoon KIM
;
Hee Seung KIM
;
Chel Hun CHOI
;
Ju Yeon YI
;
Sang Yoon PARK
;
Byoung Gie KIM
;
Author Information
- Publication Type:Brief Communication
- Keywords: Epithelial Ovarian Cancer; Chemotherapy; Durvalumab; Tremelimumab; Immunotherapy
- MeSH: Biomarkers; Biopsy; Chemotherapy, Adjuvant; Disease-Free Survival; Drug Therapy; Humans; Immunotherapy; Korea; Ovarian Neoplasms; Tumor Microenvironment
- From:Journal of Gynecologic Oncology 2019;30(6):e112-
- CountryRepublic of Korea
- Language:English
- 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
