NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study

Sponsor
British Columbia Cancer Agency
Study ID
NCT06650709
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Ovarian Cancer Stage IV

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
May 1, 2026
Completion
Nov 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib-Durvalumab-Bevacizumab
    Olaparib 300mg PO BID continuous dosing, Durvalumab 1500mg IV Day 1, Bevacizumab 10mg/kg IV Day 1 and 15 of a 28-day cycle Patients that respond to the therapy following 2 cycles will receive a 1 further cycle with the C3 Day 15 Bevacizumab omitted.

Primary Outcome Measure

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. [ Time Frame: Approximately 3 years, including 1 year of recruitment, 6 months treatment period, and 1 year of follow-up ]

Central Contacts

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