Overview

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

Status:
Recruiting

Trial end date:
2021-05-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Yonsei University

Collaborators:

AstraZeneca
Korean Gynecologic Oncology Group
National Cancer Center, Korea
Samsung Genomic Institute
Samsung Medical Center
Seoul National University Hospital

Treatments:

Antibodies, Monoclonal
Carboplatin
Durvalumab
Paclitaxel
Tremelimumab