Newly diagnosed advanced (FIGO stage III-IV) high grade epithelial ovarian, fallopian or primary peritoneal cancer MedDRA version: 27.0 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 27.0 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) Med
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serous, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer • Patients must be aged =18 years of age • All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery • Mandatory provision of tumour sample for centralised tBRCA testing • Evidence of presence or absence of BRCA1/2 mutation in tumour tissue • ECOG performance status 0-1 • Patients must have preserved organ and bone marrow function • Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 206
Exclusion criteria
Exclusion criteria: • Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology • Prior systemic anti-cancer therapy for ovarian cancer • Prior treatment with PARP inhibitor or immune mediated therapy • Planned intraperitoneal cytotoxic chemotherapy • Active or prior documented autoimmune or inflammatory disorders • Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness • Clinically significant cardiovascular disease • History of another primary malignancy except for - Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed =3 years prior to registration, and that the patient remains free of recurrent or metastatic disease) - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated carcinoma in situ without evidence of disease - Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of non-tBRCAm HRD positive patients and all non-tBRCAm patients with newly diagnosed advanced ovarian cancer.;Secondary Objective: -PFS in non-tBRCAm cohort - OS in non-tBRCAm HRD positive and all non-tBRCAm cohort - ORR, ORR pre-surgery in IDS group, duration of response, PFS2, TFST, TSST and TDT in non-tBRCAm cohort - Health-related Quality of Life Outcomes (HRQoL), global health status and ovarian cancer symptoms in non-tBRCAm cohort - pCR in patients undergoing IDS in non-tBRCAm cohort - PK and Ig of durvalumab in sampling of population - PK of olaparib in sampling of population -the potential additional clinical benefit in tBRCAm cohort (PFS, PFS2, ORR, ORR pre-surgery in IDS group, duration of response, TFST, TSST, TDT, HRQoL, proportion of patients with pCR in patients undergoing IDS);Primary end point(s): Progression Free Survival (PFS) is defined as the time from randomization to the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from assigned therapy or receives another anticancer therapy prior to progression.;Timepoint(s) of evaluation of this end point: Radiologic scans (assessed according to RECIST 1.1) performed from first patient enrolled to data cut off (approximately 52 months after first patient has received first dose of IP). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival (PFS) Overall Survival (OS) Second Progression (PFS2) Objective Response Rate (ORR) Duration of response (DoR) Time to first subsequent therapy (TFST) Time to second subsequent therapy (TSST) Time to discontinuation or death (TDT) Pathological complete response (pCR) Health related Quality of Life (HRQoL) Pharmacokinetic and Immunogenicity;Timepoint(s) of evaluation of this end point: From first patient enrolled to data cut off (approximately 52 months after first patient has received first dose of IP). A final analysis of OS, TFST, TSST, TDT will be performed at approximately 5 years following the randomization of the last nontBRCAm patient. | — |
Countries
Austria, Belgium, Brazil, Bulgaria, Canada, China, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Peru, Poland, Romania, Spain, Türkiye, United States
Contacts
Public ContactStudy Information Center
AstraZeneca Clinical
Outcome results
None listed