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 / 부인종양
Journal of Gynecologic Oncology
;
: e112-2019.
Article
in English
| WPRIM
| ID: wpr-764560
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
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Ovarian Neoplasms
/
Biopsy
/
Biomarkers
/
Chemotherapy, Adjuvant
/
Disease-Free Survival
/
Drug Therapy
/
Tumor Microenvironment
/
Immunotherapy
/
Korea
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Journal of Gynecologic Oncology
Year:
2019
Type:
Article
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