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
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
Treatments tested in this trial
- Olaparib
- Bevacizumab
- Durvalumab
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov