A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or without Bevacizumab, in Patients with BRCA 1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-based Chemotherapy
Study Description
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer.
Eligibility
- Pathologically confirmed Stage 3 or 4 ovarian cancer (OC) that is either (1) high grade serous, (2) high grade endometrioid, (3) carcinosarcoma, or (4) other epithelial OC with BRCA1/2 deleterious alteration (germline or somatic), excluding tumors that are known mismatch repair deficient/microsatellite instability high, or POLE ultramutated
- Documented variant (tumor or germline) in BRCA1 or BRCA2, suspected to be pathogenic (deleterious alteration), submission of testing report required, OR
BRCA1/2 wildtype and known HRD deficient tumor; submission of testing report required
- Must have undergone cytoreductive surgery (either primary or interval)
- Must have completed first line platinum-based therapy, where: (1) platinum chemotherapy course must have been at least 4 cycles with a maximum of 9 cycles, recommended 6 cycles unless contraindicated, or (2) intravenous, intraperitoneal, or neoadjuvant platinum therapy is permitted
- ECOG score not greater than 2
- Adequate organ function as described by Protocol
- Receipt of any investigational agent while on first course of chemotherapy
- No disease progression as determined by Investigator after chemotherapy; brain metastases patients may enroll if there is no evidence of progression and are neurologically stable off of steroid therapy
- Subject is either pregnant or nursing
- Any active infections requiring parental antibiotics
- Any evidence of intra-abdominal abscess, abdominal/pelvic fistula, gastrointestinal perforation or obstruction, and/or need for drainage nasogastric or gastrostomy tube
- Inability to swallow oral medication
- History of myelodysplastic syndrome and/or acute myeloid leukemia, or history of allogenic bone marrow transplant
- Concomitant usage of strong or moderate CYP3A inducers
- Known hypersensitivity to the study drug or any of its associated components