Clinical trial · Interventional
Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer
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)
NCT04361370CI-TRIAL-00051307OPEB-01unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib-Pembrolizumab-Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- BRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer
- interventionNames
- Drug: Olaparib-Pembrolizumab-Bevacizumab
Primary outcomes (1)
- measure
- progression-free survival(6 months PFS rate)
- timeFrame
- 6 months
- description
- To determine the clinical effectiveness of the study treatment assessed using progression free survival(6months) according to RECIST v1.1 criteria (Investigator determined)
Secondary outcomes (5)
- measure
- Overall survival (OS)
- timeFrame
- Up to 1year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee YJ, Lim MC, Kim BG, Ngoi NY, Choi CH, Park SY, Tan DS, Go Y, Lee JY. A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01). J Gynecol Oncol. 2021 Mar;32(2):e31. doi: 10.3802/jgo.2021.32.e31. Epub 2021 Jan 27. PMID 33559413