NCT05952453

Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro, Maintenance Olaparib/Pembro

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 tissue will be used for flow cytometry (to determine populations of cells - ie. Tregs, TILs, NK cells, MDSCs, DCs and other APCs), RNAseq (specifically looking at "hot" and "cold" signatures), proteomics (PD-L1 status and other protein expression), and immune score staining (based on the quantification of CD3 and CD8 both at the tumor center and the margins). The benefit of this study compared to other on-going upfront studies in ovarian cancer is that all patients will receive PARP inhibitor and pembrolizumab maintenance. Bevacizumab will be allowed after interval debulking surgery with the last 2 cycles of chemotherapy and can be continued as maintenance in these patients. Additionally, if a patient does not have a CR at the conclusion of their chemotherapy, bevacizumab can be added during the maintenance period.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	neoadjuvant treatment , followed by surgery, then maintenance chemotherapy
DRUG	olaparibp, embro	maintenance chemotherapy : olaparib, pembro

Timeline

• Start date: 2025-02-17
• Primary completion: 2028-10-30
• Completion: 2030-12-30
• First posted: 2023-07-19
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study