Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

1. Neoadjuvant treatment:

   Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing)
2. Interval debulking surgery
3. Adjuvant treatment:

Standard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)

Neoadjuvant chemotherapy+Durvalumab+Tremelimumab

Jung-Yun Lee, MD., Ph.D

Myong Cheol Lim, MD, PH.D

Byoung-Gie Kim, MD, PH.D

Jae-Woen Kim,, PH.D

Jung-Yun Lee, MD, Ph.D

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.

This study is single arm phase II study to evaluate efficacy and safety of durvalumab and tremelimumab and chemotherapy in treatment-naïve clinical stage IIIC/IV ovarian cancer.

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

12-months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

Response rate by RECIST version 1.1 after neoadjuvant chemotherapy(after the completion of 3rd cycle)

Immune-related response after neoadjuvant chemotherapy(after the completion of 3rd cycle)

Response rate by PERCIST after neoadjuvant chemotherapy(after the completion of 3rd cycle)

R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)

The rate of chemotherapy response score 3 after neoadjuvant chemotherapy(after the completion of 3rd cycle)

Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy

Spots Global Cancer Trial Database for neoadjuvant chemotherapy+durvalumab+tremelimumab