Status:
ENROLLING_BY_INVITATION
Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer
Lead Sponsor:
Yonsei University
Conditions:
Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
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 BR...
Detailed Description
'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with platinum-sensitive who...
Eligibility Criteria
Inclusion
- 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:
- ANC≥1500/µL
- PLT≥100 000/µL
- Hemoglobin≥9.0 g/dL or ≥5.6 mmol/L
- Creatinine≤1.5 × ULN or calculated creatinine clearance≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
- Total bilirubin≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN
- AST (SGOT) and ALT (SGPT)≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- 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
- 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
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04361370
Start Date
October 28 2020
End Date
August 1 2026
Last Update
April 19 2021
Active Locations (1)
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1
Yonsei Severance Hospital
Seoul, South Korea