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
de En
| WPRIM
| ID: wpr-764560
Bibliothèque responsable:
WPRO
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
Mots clés
Texte intégral:
1
Indice:
WPRIM
Sujet Principal:
Tumeurs de l'ovaire
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Biopsie
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Marqueurs biologiques
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Traitement médicamenteux adjuvant
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Survie sans rechute
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Traitement médicamenteux
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Microenvironnement tumoral
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Immunothérapie
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Corée
Limites du sujet:
Humans
Pays comme sujet:
Asia
langue:
En
Texte intégral:
Journal of Gynecologic Oncology
Année:
2019
Type:
Article