NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study

ConditionOvarian Cancer Stage IV

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18+

SponsorBritish Columbia Cancer Agency

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations

Histologically proven high grade serous ovarian/ fallopian tube or primary peritoneal cancer.

Chemotherapy naïve for high grade serous ovarian/ fallopian tube or primary peritoneal cancer.

FIGO Stage IVA/B disease not suitable for primary debulking surgery but must have the intention of proceeding to interval surgical debulking if treatment response is demonstrated

Disqualifiers

Known germline BRCA1/2 mutation carriers or known somatic BRCA1/2 mutation associated HGSOC (prior to screening)

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the Triplet Combination (olaparib, durvalumab, bevacizumab).

Use of any other anti-cancer therapy including systemic, targeted, immunotherapy, hormonal, biological, chemotherapy, other novel agents or investigational agents within 4 weeks of registration.

Participation in another clinical trial with an investigational product within 4 weeks of registration

Trial design

Design model

Single group

Treatments tested in this trial

Olaparib
Drug
Olaparib 300mg orally twice daily on a continuous dosing schedule for a maximum of 3 x 28-day cycles.
Bevacizumab
Drug
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).
Durvalumab
Drug
Durvalumab 1500mg intravenously on Day 1 of the 28 day cycle for a maximum of 3 cycles.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Olaparib-Durvalumab-BevacizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

To determine the efficacy of the triplet combination Olaparib-Durvalumab-Bevacizumab in the neoadjuvant setting in subjects with FIGO Stage IV high grade serous ovarian cancer.

Objective Response Rate (complete response (CR) + partial response (PR)) at 8 weeks based on RECIST 1.1. as assessed by the Investigator.

Time frame

Approximately 3 years, including 1 year of recruitment, 6 months treatment period, and 1 year of follow-up

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

AstraZeneca

Collaborator

Ozmosis Research Inc.