A Phase II Study in Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer Evaluating Carbo/Taxol/Pembro in Patients Receiving Neoadjuvant Chemotherapy (NACT) Followed by Olaparib/Pembro Maintenance
University of Alabama at Birmingham
Summary
this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.
Description
This is a single-arm, phase II trial for patients with primary Stage III/IV advanced epithelial ovarian cancer who will receive neoadjuvant chemotherapy. All patients will receive a one-cycle lead-in of carboplatin (with or without) paclitaxel followed by three cycles of carboplatin, paclitaxel, and pembrolizumab prior to interval debulking surgery (IDS), and three cycles after IDS, followed by olaparib and pembrolizumab maintenance. Patients will receive a pre-treatment biopsy. The study will be done at 1 site and fresh tissue will be required pre-treatment as well as at the time of IDS. This…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer. 2. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery. 3. Participant that is a candi…
Interventions
- DrugCarboplatin
neoadjuvant treatment , followed by surgery, then maintenance chemotherapy
- Drugolaparibp, embro
maintenance chemotherapy : olaparib, pembro
Location
- O'Neal Comprehensive Cancer Center at UABBirmingham, Alabama