Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer

Sponsor
National Cancer Center Hospital East
Study ID
NCT04417192
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib will be administered at a dose of 300mg as oral dose, twice a day.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Jul 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib or Olaparib Plus Pembrolizumab
    Cohort 1 : Olaparib will be administered for 6 weeks before surgery. Cohort 2 : Olaparib and Pembrolizumab will be administered simultaneously for 2 cycles(6 weeks) before surgery.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 6 weeks ]

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