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

Sponsor
Yonsei University
Study ID
NCT03899610
Phase
PHASE2
Status
Unknown

Conditions

  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IV

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant chemotherapy+Durvalumab+Tremelimumab — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jul 4, 2019
Status verified
Sep 2020
Primary completion
May 31, 2021
Completion
May 31, 2021

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy+Durvalumab+Tremelimumab
    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)

Primary Outcome Measure

Progression-free survival(PFS) [ Time Frame: 12 months ]

Central Contacts

Related Studies