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NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study

NCT06650709 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-23

No results posted yet for this study

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

Conditions

  • Ovarian Cancer Stage IV

Interventions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ozmosis Research Inc.

    collaborator INDUSTRY

  • British Columbia Cancer Agency

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650709 on ClinicalTrials.gov