A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)

Summary

The primary objective of this trial is to evaluate the synergistic effects of durvalumab and tremelimumab plus chemotherapy in advanced-stage ovarian cancer. Ovarian cancer is the deadliest gynecologic cancer. The current standard therapy is surgical cytoreduction followed by taxane-platinum combination chemotherapy. However, most patients with advanced-stage ovarian cancer will experience a relapse of disease. Therefore, there is an urgent need to improve outcomes of patients with this aggressive cancer. Research hypothesis: Adding durvalumab and tremelimumab to current neoadjuvant chemotherapy (front-line therapy) in advanced-stage ovarian cancer can increase response rate and improve patient's outcome such as progression-free survival and overall survival with minimal effects on safety.

Timeline

Start

2019-07-04

Primary completion

2021-05

Completion

2021-05

Publications

• Park J, Lee JB, Lim MC, Kim BG, Kim JW, Kim S, Choi CH, Kim HS, Park SY, Lee JY; KGOG investigators. Phase II study of durvalumab and tremelimumab with front-line neoadjuvant chemotherapy in patients with advanced-stage ovarian cancer: primary analysis in the original cohort of KGOG3046/TRU-D. J Immunother Cancer. 2023 Oct;11(10):e007444. doi: 10.1136/jitc-2023-007444.
• Lee JY, Kim JW, Lim MC, Kim S, Kim HS, Choi CH, Yi JY, Park SY, Kim BG; KGOG investigators. 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. J Gynecol Oncol. 2019 Nov;30(6):e112. doi: 10.3802/jgo.2019.30.e112.

Drugs

Indications