MOCCA: This phase II trial is trying to determine if treatment with an immunotherapy (durvalumab) is beneficial for patients who have recurrent ovarian cancerA Multicentre Phase II Randomised Trial of Durvalumab (MEDI4736) Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas

Exclusion

Patients will not be eligible for inclusion in this study if any of the following criteria apply:

1. Women who are pregnant or nursing
2. Prior exposure to an immune checkpoint inhibitor (anti-PD-1 or anti-PDL-1 antibody)
3. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
4. Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
5. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
6. Have active, acute, or chronic clinically significant infections or bleeding including but not limited to active bleeding diatheses, patients known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV),
7. History of primary immunodeficiency
8. History of allogeneic organ transplant
9. Known history of previous clinical diagnosis of tuberculosis
10. Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg);
11. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months or unstable angina

12. Chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec. calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction.

    • By Fridericia's formula: QTc = QT/(RR^0.33) Where - RR interval = 60 / HR ; HR = Heart rate in beats per minute.

13. Have additional uncontrolled serious medical or psychiatric illness.
14. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of investigational product
15. Require therapeutic doses of anti-coagulation with warfarin or warfarin derivatives. However, treatment with low molecular weight heparin (LMWH) is allowed.
16. Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
17. History of leptomeningeal carcinomatosis

18. History of another primary malignancy unless treated with curative intent and with no known active disease ≥5 years except:

    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    • Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ
19. Absence of a tumour sample (archival and/or recent).

20. Current or prior use of systemic immunosuppressive medications within 28 days before the first dose of durvalumab (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents)

    • Patients on systemic corticosteroids at physiological doses, which do not exceed 10 mg/day of prednisone, or an equivalent corticosteroid are allowed
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
21. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
22. Patients who are pregnant, breast-feeding or of reproductive potential who are not employing an effective method of birth control
23. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results