Overview

D9319C00001- 1L OC Mono Global RCT

Status:
Recruiting
Trial end date:
2025-07-02
Target enrollment:
0
Participant gender:
Female
Summary
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Olaparib
Criteria
Key Inclusion Criteria:

- 1,Participants must be ≥18 years at the time of (pre-)screening

2,Histological and staging criteria:Female participants who must have histologically
newly diagnosed high-grade serous or endometrioid ovarian cancer, fallopian tube
cancer, or primary peritoneal cancer that is Stage III or IV according to the
International FIGO 2009.

3, Participants are eligible if they fulfil any of the following surgical criteria:

- Stage III: primary debulking surgery with macroscopic residual disease post-surgery,
neoadjuvant chemotherapy, or inoperable.

- Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant
chemotherapy, or inoperable.

4, Chemotherapy criteria:

- Participants must have received platinum-based chemotherapy consisting of a minimum of
6 treatment cycles and a maximum of 9, however, if platinum-based therapy must be
discontinued early as a result of toxicities specifically related to the platinum
regimen, participants must have received a minimum of 4 cycles of the platinum
regimen.

- Participants must have, in the opinion of the investigator, clinical CR or PR as per
RECIST 1.1 criteria with no measurable lesion > 2 cm on the post-treatment scan and
have no clinical evidence of disease progression or a rising CA-125 level (see
inclusion criterion 5), following completion of this chemotherapy course.

- A participant who received interval debulking surgery must have had ≥ 2 postoperative
cycles of platinum-based therapy.

5, Participants must meet one of the criteria specified below for pre-treatment CA-125
measurements as follows:

- CA-125 in the normal range or

- CA-125 decrease by ≥ 90% during their front-line therapy that is stable for at least 7
days (ie, no increase > 15% from nadir. If the first value is greater than the upper
limit of normal (ULN), a second assessment must be performed at least 7 days after the
first. If the second assessment is > 15% more than the first value, the participant is
not eligible).

6, Participants should not have received bevacizumab with first-line chemotherapy or
be planned to receive bevacizumab maintenance therapy.

7, ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
prior to randomisation.

8, Provision, at pre-screening, of a formalin-fixed, paraffin-embedded (FFPE) tumour
sample to assess tBRCA status and for HRD testing centrally. The centrally performed
tBRCA test results must be available prior to randomisation and must indicate that the
participant has a BRCAwt tumour, defined by the absence of a deleterious or suspected
deleterious BRCA mutation by central testing.

9, Adequate organ and marrow function.

Key Exclusion Criteria:

- 1, Participants with stable disease or progressive disease on the post-treatment scan
or clinical evidence of progression at the end of the participant's first-line
chemotherapy treatment, or any evidence of progressive disease prior to randomization.

2, Participant has mucinous or clear cell subtypes of epithelial ovarian cancer,
carcinosarcoma, undifferentiated ovarian cancer, non-epithelial ovarian cancer,
borderline tumours or low grade epithelial ovarian tumours (applies to fallopian tube
and primary peritoneal tumours where applicable).

3, Participants with Stage III disease who have had complete cytoreduction (ie, no
macroscopic residual disease) at their primary debulking surgery.

4, Participants who have undergone ˃ 2 debulking (cytoreductive) surgeries.

5, History of another primary malignancy except for malignancy treated with curative
intent with no known active disease ≥ 5 years before the first dose of study
intervention including adequately treated non-melanoma skin cancer, curatively treated
in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, Grade 1
endometrial carcinoma. Participants with a history of localised triple negative breast
cancer may be eligible, provided they completed their adjuvant chemotherapy more than
three years prior to registration, and that the participant remains free of recurrent
or metastatic disease.

6, Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy,
excluding alopecia and CTCAE Grade 2 peripheral neuropathy. Participants with
irreversible toxicity that is not reasonably expected to be exacerbated by study
intervention may be included after consultation with the AstraZeneca study physician.

7, Participant is immunocompromised

8, Prior exposure to a PARP inhibitor, including olaparib

9, Any concurrent anticancer treatment

10, Currently pregnant or breast-feeding