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.
- KMID: 2458908
- DOI: http://doi.org/10.3802/jgo.2019.30.e112
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 Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Advanced ovarian cancer: what should be the standard of care?
- Phase II Trial of Combined Durvalumab Plus Tremelimumab with Proton Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Early port-site metastasis during neoadjuvant chemotherapy in advanced stage ovarian cancer: report of two cases
- Hyperthermic intraperitoneal chemotherapy in advanced ovarian cancer
- The role of neoadjuvant chemotherapy in ovarian cancer patients with extensive tumor burden
