C56 Malignant neoplasm of ovary Malignant neoplasm of ovary
Conditions
Interventions
None listed
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Informed consent 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and in this protocol. All patients must sign both the Pre-screen ICF and main ICF: (i) The separate (Pre-screen) ICF will be provided for the mandatory tBRCA testing. (ii) The main ICF for participation in the study. The main consent form includes a separate consent for the optional Genomics Initiative research component of the study (if a patient declines to participate in this research, there will be no penalty or loss of benefit to the patient and the patient will not be excluded from other aspects of the study). tBRCA mutation status Patients MUST meet the following criteria to be enrolled in the study 2. Patients must provide sufficient formallin fixed, paraffin embedded (FFPE) tumour sample suitable for the Myriad myChoice HRD Plus test Determination of tBRCAm status: Subject to local regulations, all patients must provide an FFPE tumour specimen sample for tissue-based BRCA1/2 gene testing using the clinical trial assay (CTA) known as the myChoice HRD Plus assay. The results of this test MUST be available prior to Day 1 of Cycle 2. • If the test results indicate that the patient has deleterious or suspected deleterious mutation in BRCA1 or BRCA2, the patient may (subject to fulfilling all other selection criteria) be eligible for allocation to the tBRCAm single arm cohort of the study. • • If the test results indicate that the patient has no detected deleterious or suspected deleterious mutation in BRCA1 and BRCA2 the patient may (subject to fulfilling all other selection criteria) be eligible for randomisation in one of 3 non-tBRCAm arms. • • If a valid tBRCAm test result is not obtained prior to Day 1 of Cycle 2, the patient will be withdrawn from the study and considered as a screen failure. The cohort allocation and randomisation procedures are provided in Section 6.3.1. Patients MUST meet the following criteria prior to receiving Cycle 1 of chemotherapy. Patients MUST meet the following criteria prior to allocation/randomisation except for criteria 7, 8, and 9 Age 3. Patients must be aged =18 years of age. For patients enrolled in Japan that are aged <20 year, a written informed consent should be obtained from the patient and her legally acceptable representative*. Type of patient and disease characteristics 4. Female patients with newly diagnosed, histologically confirmed, advanced (Federation Internationale de Gynecologie et d´Obstetrique [FIGO] Stage III or IV) high grade epithelial ovarian cancer including high grade serous, high grade endometriod, clear cell ovarian cancer or carcinosarcoma (malignant mixed Mullerian tumour [MMMT] of the ovary, provided high grade epithelial component is present); ovarian cancer = ovarian, primary peritoneal cancer and / or fallopian-tube cancer. 5. All patients must have had either*: - Upfront primary surgery - OR, plan to undergo chemotherapy with interval debulking surgery 6. Patients must have a life expectancy of at least 12 months*. 7. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of Day 1 of Cycle 1 as defined below: - Haemoglobin (Hb) =10.0 g/dL - Absolute neutrophil count (ANC) =1.5 x 109/L - Platelet count =100 x 109/L - Total bilirubin =1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert´s syndrome,
Exclusion criteria
Exclusion criteria: Medical conditions 1 Non-epithelial ovarian cancer, borderline tumours, low grade epithelial tumours or mucinous histology. 2 Active or prior documented autoimmune or inflammatory disorders (including but not limited to inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). 3 History of another primary malignancy 4 Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML*. 5 Patients with known brain metastases. 6 History of leptomeningeal carcinomatosis* 7 History of active primary immunodeficiency* 8 Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history of TB, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc], followed by a negative hepatitis B virus DNA test and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA For additional Information please refer to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator assessment using modified RECIST 1.1 NAME OF THE RESULT: Progression free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomisation to first progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator assessment using modified RECIST 1.1 NAME OF THE RESULT: Progression free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomisation to first progression or death;Eficacia de durvalumab y olaparib evaluada mediante la OS en el tratamiento de primera linea de pacientes no tBRCAm con cancer de ovario avanzado recientemente diagnosticado. NAME OF THE RESULT: Overall survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From date of randomisation to death;investigator assessment of radiological, clinical or CA125 progression or death NAME OF THE RESULT: Time to second progression (PFS2), Objective response rate(ORR), ORR pre-surgery PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: from date of randomisation to second progression | — |
Countries
Austria, Belgium, Brazil, Bulgaria, Canada, China, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea South, Peru, Poland, Romania, Spain, Sweden, Turkey, United States
Outcome results
None listed