Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients

Inclusion Criteria:

1. Written informed consent and obtained from the subject prior to performing anyprotocol-related procedures, including screening evaluations.

2. Age ≥ 18.

3. Patients with histologically confirmed, advanced (FIGO stage IIIA, IIIB, IIIC, or IVof the 2014 FIGO classification) high grade serous or high grade endometrioid (basedon local histopathological findings) ovarian cancer, fallopian tube cancer, primaryperitoneal cancer and clear cell carcinoma of the ovary in first line therapy.

4. Availability of archival tumor tissue for central next-generation sequencing (NGS)Analysis and no Detection BRCA mutation (BRCAnegative).

5. Treatment with Bevacizumab or respective biosimilar for 12 to 15 months, independentof dosage.

6. Patients who have completed first line platinum-taxane chemotherapy and at leaststable disease after treatment with Bevacizumab before randomization.

7. Patients must be randomized at least 3 weeks and no more than 9 weeks after theirlast dose of Bevacizumab (last dose is the day of the last infusion) and all majortoxicities from the previous chemotherapy must have resolved to CTCAE grade 1 orbetter (except alopecia and peripheral neuropathy).

8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

9. Patients must have normal organ and bone marrow function:

10. Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to Screeninghemoglobin assessment

11. Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L

12. Platelet count ≥ 100 x 109 /L

13. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); < 2 × ULN ifhyperbilirubinemia is due to Gilbert's syndrome

14. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤3 x ULN, unless liver metastases are present in which case theymust be ≤ 5 x ULN

15. Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance > 30 mL/min

16. Patients not receiving anticoagulant medication who have an InternationalNormalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 xULN.

17. Postmenopausal or evidence of non-childbearing status for women of childbearingpotential prior to the first dose of study treatment. Female patients ofchildbearing potential must have a negative serum pregnancy test result ≤3 daysprior to administration of the first dose of rucaparib.

Patients are considered to be of childbearing potential unless 1 of the following applies:

1. Considered to be permanently sterile. Permanent sterilization includes hysterectomy,bilateral salpingectomy, and/or bilateral oophorectomy; or

2. Is postmenopausal, defined as no menses for at least 12 months without analternative medical cause. A high follicle-stimulating hormone (FSH) levelconsistently in the postmenopausal range (30 milli International Units/milliliter (mIU/mL) or higher) may be used to confirm a postmenopausal state in women not usinghormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm apostmenopausal state.

Female patients of reproductive potential must practice highly effective methods (failure rate < 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of rucaparib or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (eg, calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate.

Exclusion Criteria:

1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germcell tumors) and Ovarian tumors of low malignant potential (e.g. borderline tumors),or low grade serous ovarian cancer, or low grade endometrioid ovarian cancer, ormucinous carcinoma.

2. Patients with myelodysplastic syndrome/acute myeloid leukemia history.

3. Patients receiving radiotherapy within 6 weeks prior to study treatment.

4. Major surgery within 4 weeks of starting study treatment and patients must haverecovered from any effects of any major surgery.

5. Previous allogeneic bone marrow transplant.

6. Use of any other PARP-inhibitor in first line therapy.

7. Administration of other simultaneous chemotherapy drugs, any other anti-cancertherapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during thetrial treatment period (hormonal replacement therapy is permitted as are steroidalantiemetics).

8. Clinically significant (e.g. active) cardiovascular disease.

9. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) orSub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.

10. History or evidence of hemorrhagic disorders within 6 months prior to randomization.

11. Evidence of bleeding diathesis or significant coagulopathy (in the absence ofcoagulation).

12. History or evidence for brain metastases or spinal cord compression.

13. History or evidence upon neurological examination of central nervous system (CNS)disease, unless adequately treated with standard medical therapy (e.g. uncontrolledseizures).

14. Significant traumatic injury during 4 weeks prior to randomization.

15. Non-healing wound, active ulcer or bone fracture. Patients with granulatingincisions healing by secondary intention with no evidence of facial dehiscence orinfection are eligible but require 3 weekly wound examinations.

16. Current, clinically relevant bowel obstruction, including sub-occlusive disease,related to underlying disease.

17. Evidence of any other disease, metabolic dysfunction, physical examination findingor laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug or puts the patient at high riskfor treatment related complications.

18. Pregnant or lactating women, women of child-bearing potential who do not agree tothe usage of highly effective contraception methods (see inclusion criteria).

19. Participation in another clinical study with an investigational product immediatelyprior to randomization.

20. Patients unable to swallow orally administered medication and patients withgastrointestinal disorders likely to interfere with absorption of the studymedication.

21. Patients with a known hypersensitivity to Rucaparib or any of the recipients of theproduct.

22. Known human immunodeficiency virus (HIV) or acquired immunodeficiency Syndrome (AIDS)-related illness, or history of chronic hepatitis B or C.

23. Other active malignancy requiring treatment.

24. Patient who might be dependent on the sponsor, Clinical Research Organization (CRO),site or the investigator.

25. Patient who has been incarcerated or involuntarily institutionalized by court orderor by the authorities § 40 Abs. 1 S. 3 Nr. 4 Arzneimittelgesetz (AMG).