Ovarian cancer MedDRA version: 20.0 Level: HLT Classification code 10033129 Term: Ovarian neoplasms malignant (excl germ cell) System Organ Class: 100000004864
Conditions
Interventions
Product Name: MEDI 9447
Pharmaceutical Form: Powder for solution for injection
Product Name: Durvalumab
Product Code: MEDI 4736
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Sponsors
NSGO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Cohort A A patient will be eligible for inclusion only if all of the following criteria are fulfilled: 1.Platinum-sensitive disease: defined as disease progression = 6 months following the last administered dose of platinum-based therapy. Patients must have received atleast one line of chemotherapy for platinum-sensitive disease. OR 2.Platinum-resistant disease: defined as disease progression 10% of tumor cells positive) will enter this trial. 8.Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations according to protocol. 9.Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment. 10.Patients must give informed consent. 11.DPatients must be at least 18 years of age. 12.DECOG performance status 0-1 13.DSerum albumin >30g/l. 14.Adequate organ function oAbsolute neutrophil count (ANC) =1,500/mcL (without growth factors for >21 days) oPlatelets >100,000/mcL (without platelet transfusion for >21 days) oHemoglobin = 9g/dl (5.6 mmol/L), without blood transfusion for >21 days oSerum creatinine =1.5x upper limit of normal (ULN) or calculated creatinine clearance =50mL/min using Cockcroft-Gault formula. oTotal bilirubin =1.5x ULN. Total bilirubin =3x ULN in the presence of liver metastases. oAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5x ULN unless liver metastases are present, in which case they must be =5x ULN. 15.Life expectancy of at least 12 weeks. 16.Patients must be fit to receive Investigational medical products (IMPs) (MEDI9447 + durvalumab). 17.Patients of child-bearing potential: who are sexually active must use at least one highly effective method of contraception from the time of screening, and must agree to continue using such pre-cautions for 90 days after the last dose of MEDI9447 + durvalumab combination therapy. Non-sterilised male partners of a female subject must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible phy- sician. Not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female subjects should re-frain from breastfeeding throughout this period. 18. All patients: Patients should not donate blood or blood components while participating in this study and through 90 days after re eipt of the final dose of MEDI9447 + durvalumab combination therapy. 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 subje
Exclusion criteria
Exclusion criteria: 1.Subjects using immunosuppressive medications within 14 days prior to first dose with the excep-tion of topical (intranasal, inhaled, local injection, systemic (prednison equivalent 10 mg/day or less) or as needed for hypersentivity reactions such as CT scan premedication. 2.Immunodeficiency or organ transplant 3.Live vaccines within 28 days prior to the first dose. 4.Major surgery within 28 days prior to the first dose.. 5.Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers. 6.Cancer therapies (chemotherapy, ra ry, immunotherapy, biologic or hormonal therapy) within 28 days prior to the first dose. 7.Concurrent treatment with an investigational agent or participation in another clinical trial. 8.Previous malignant disease: patients are not eligible for the study if actively being treated of inva-sive cancer other than ovarian cancer. Patients with previous malignant disease other than ovarian cancer who are relapse-free and treatment-free for more than three years may enter this study. Pa-tients with previous history of in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin carcinoma can enter this trial. 9.Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficien-cy 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] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 10.History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months. 11.History of clinically significant hemorrhage in the past 3 months. 12.Untreated CNS disease, leptomeningeal disease or cord compression. Subjects with treated dis-ease should have at least 4 weeks of neurologic and radiographic stability and be off of steroids for 14 days. 13.Significant cardiovascular disease's, including uncontrolled hypertension, clinically relevant car-diac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure > NYHA II, severe peripheral vascular disease, QT prolongation >470msec, clinically significant pericardial effusion. 14.Persistance of clinically relevant therapy related toxicity from previous anticancer therapy (any grade 3-4 toxicity or grade =2 neuropathy). 15.Known hypersensitivity to the trial drugs, or to their excipients. 16.DHas had prior exposure to IMPs, or any other immunotherapy. 17.DActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: -Patients with vitiligo or alopecia -Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone re-placement -Any chronic skin condit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective in part 1 is to obtain preliminary evidence of efficacy of novel agents for the management of relapsed ovarian c er, and in part 2 efficacy of novel agents compared to the standard of care (SoC). Disease control rate (DCR) (CR+PR+SD) according to RECIST v1.1 at 16 weeks. ;Secondary Objective: •Progression-Free Survival (PFS) by RECIST v1.1: at 6 & 12 months and median PFS •PFS by Immune-RECIST: at 6 & 12 months and median PFS •Overall survival •Objective response rate according to RECIST v1.1 (ORR) •Duration of (Overall) Response (DoR) •Safety and tolerability.4.3. ;Primary end point(s): •Disease control rate (DCR) (CR+PR+SD) at 16 weeks. ;Timepoint(s) of evaluation of this end point: Every 8 weeks until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Progression-Free Survival (PFS) by RECIST v1.1: at 6 & 12 months and median PFS •PFS by Immune-RECIST at 6 & 12 months and median PFS •Overall survival (OS) •Objective response rate according to RECIST v1.1 (ORR) •Duration of (Overall) Response (DoR) •Safety and tolerability. ;Timepoint(s) of evaluation of this end point: every 8 weeks until disease progression and registration of survival data | — |
Countries
Canada, Denmark, Finland, Japan, Korea, Republic of, Norway
Contacts
Public ContactProject Manager
NSGO
Outcome results
None listed