Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer
NCT04417192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-07-06
Summary
To evaluate the efficacy and safety of preoperative olaparib monotherapy and preoperative olaparib plus pembrolizumab combination therapy in patients with untreated stage III, IV high-grade serous or Grade 3 endometrioid ovarian cancer with Homologous Recombination Deficiency (HRD) positivity.
Conditions
Interventions
- DRUG
-
Olaparib will be administered at a dose of 300mg as oral dose, twice a day.
- DRUG
-
Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Cancer Center Hospital East
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-01
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
Countries
- Japan
Study Locations
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