NCT06650709

NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study

A Phase 2, Proof of Concept Trial Investigating the Safety and Efficacy of the Neoadjuvant Triplet Olaparib, Durvalumab and Bevacizumab in Advanced FIGO Stage IV High Grade Serous Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a single arm, proof of concept phase 2 study. Subjects with a suspected or confirmed diagnosis of high grade serous ovarian cancer who are not thought to be candidates for primary debulking surgery and are considered candidates for neoadjuvant chemotherapy and are not known to have BRCA mutation associated HGSOC will be considered for the trial. Patients will be given the following triplet therapy for 2 cycles: Olaparib 300mg PO BID continuous dosing, Durvalumab 1500mg IV day 1, Bevacizumab 10mg/kg IV on day 1 and 15 of a 28-day cycle. Patients that respond to the therapy following 2 cycles will receive 1 further cycle followed by interval cytoreductive surgery planned 3-4 weeks after completion of cycle 3 and at least 28 days from the last dose of Bevacizumab. Following surgery, patients will revert back to standard of care (SOC) treatment and receive up to 6 cycles of chemotherapy followed by SOC recommended maintenance treatments as determined by the local treating oncology teams. All subsequent treatments received and their response will be recorded as part of the study data collection up to and including first documented progression. Patients that do not respond to the therapy after 2 cycles will discontinue the triplet therapy and switch to salvage standard of care treatment.

Conditions

• Ovarian Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib 300mg orally twice daily on a continuous dosing schedule for a maximum of 3 x 28-day cycles.
DRUG	Bevacizumab	Bevacizumab 10mg/kg intravenously on Day 1 and 15 of the 28 day cycle for a maximum of 3 cycles (Cycle 3, Day 15 will be omitted).
DRUG	Durvalumab	Durvalumab 1500mg intravenously on Day 1 of the 28 day cycle for a maximum of 3 cycles.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-05-01
• Completion: 2028-11-01
• First posted: 2024-10-21
• Last updated: 2024-10-23