Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer Clinical Trial
— OPEB-01Official title:
A Single-arm Phase II Study of Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer (OPEB-01)
| Verified date | April 2021 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.
| Status | Enrolling by invitation |
| Enrollment | 44 |
| Est. completion date | August 2026 |
| Est. primary completion date | May 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years and older |
| Eligibility | Inclusion Criteria: - Participant has histologically confirmed diagnosis of high-grade predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC, primary peritoneal cancer, or fallopian tube cancer will be enrolled in this study (only up to 8 patients with clear cell carcinoma will be included and mucinous carcinoma will not be included). - Participant has received 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 months' period between penultimate platinum regimen and progression of disease - Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen - Participant is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA 1/2 and PD-L1 status prior to enrollment - Female participants who are at least 20 years of age and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Participant has adequate organ function as defined in the following: 1. ANC=1500/µL 2. PLT=100 000/µL 3. Hemoglobin=9.0 g/dL or =5.6 mmol/L 4. Creatinine=1.5 × ULN or calculated creatinine clearance=30 mL/min for participant with creatinine levels >1.5 × institutional ULN 5. Total bilirubin=1.5 ×ULN OR direct bilirubin =ULN for participants with total bilirubin levels >1.5 × ULN 6. AST (SGOT) and ALT (SGPT)=2.5 × ULN (=5 × ULN for participants with liver metastases) 7. International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT)=1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants Exclusion Criteria: - Participant has mucinous, germ cell, or borderline tumor of the ovary - Participant has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2 - Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis - Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML - Participant has a known additional malignancy that is progressing or has required active treatment within the past 3 years - Participant has known active CNS metastases and/or carcinomatous meningitis - Participant has a known history of active TB (Bacillus Tuberculosis) - Participant has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection - Participant has uncontrolled hypertension, defined as systolic > 140 mmHg or diastolic > 90 mmHg documented by 2 blood pressure readings taken at least 1 hour apart - Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to randomization |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Yonsei Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | progression-free survival(6 months PFS rate) | To determine the clinical effectiveness of the study treatment assessed using progression free survival(6months) according to RECIST v1.1 criteria (Investigator determined) | 6 months | |
| Secondary | Overall survival (OS) | Up to 1year | ||
| Secondary | Time to tumour progression (TTP) | Up to 1year | ||
| Secondary | Time to first subsequent treatment(or death) | The date of first documented first subsequent treatment or date of death, assessed up to 72 months | ||
| Secondary | Time to second subsequent treatment | The date of first documented second subsequent treatment assessed up to 72 months | ||
| Secondary | progression-free survival | Up to 1year |