drugset / Trial / NCT06650709

NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study

NCT06650709 ↗

NaSingle-groupOpen-labelTreatment

Summary

The goal of this phase 2 clinical trial is to learn if the three treatments olaparib, durvalumab and bevacizumab can treat participants with a diagnosis of stage 4 high grade serous ovarian cancer that is too advanced to undergo upfront surgery. The main questions it aims to answer are: Is the treatment able to shrink the cancer sufficiently for participants to undergo surgery? Is the combination of treatments safe in this neoadjuvant (before surgery) setting? This is a single arm study with no comparator arm. Participants will receive the treatment up to 3 cycles with each drug given as follows in a 28-day cycle: Olaparib orally on a twice daily continuous dosing schedule Durvalumab given intravenously on day 1 Bevacizumab given intravenously on day 1 and 15 (Day 15 omitted in C3) Participants will be assessed throughout the study for safety and efficacy endpoints

Timeline

Start
2024-11-01
Primary completion
2026-05-01
Completion
2028-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Olaparib Small molecule 300 mg Oral

Indications