By InvitationPhase 2

Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer

South Korea44 participantsStarted 2020-10-28

Plain-language 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 BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.

Who can participate

Age range20 Years

SexFEMALE

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Inclusion criteria

✓. 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

What they're measuring

progression-free survival(6 months PFS rate)

Timeframe: 6 months

Trial details

NCT IDNCT04361370

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer trials