Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Recurrent Ovarian Cancer

Sponsor
Kosei Hasegawa, MD, PhD
Study ID
NCT05158062
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinoma, Ovarian Epithelial

Eligibility Criteria

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

Interventions

  • pembrolizumab — BIOLOGICAL
    pembrolizumab 200 mg every three weeks (Q3W)
  • olaparib — DRUG
    olaparib 300 mg twice daily (BID) during maintenance period
  • bevacizumab — BIOLOGICAL
    bevacizumab 15 mg/kg Q3W
  • carboplatin — DRUG
    carboplatin AUC=5 or 6 Q3W during treatment period
  • paclitaxel — DRUG
    paclitaxel 175 mg/m2 Q3W during treatment period
  • docetaxel — DRUG
    docetaxel 60 \~ 70 mg/m2 Q3W during treatment period

Study Details

This trial is a multicenter, single-arm, phase II study evaluating the efficacy of pembrolizumab and bevacizumab in combination with platinum-based chemotherapy (PBC) followed by pembrolizumab, bevacizumab and olaparib as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.This study is planned to enroll eligible 35 patients from multiple study sites in Japan.

Key Dates

Start date
Apr 20, 2022
Status verified
Apr 2022
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib
    Participants will continue treatment period up to 6 cycles and enter maintenance period after treatment period. Study treatment will be continued until progressive disease (PD) based on RECIST 1.1, death, unacceptable toxicity, or participant withdrawal from the study.

Primary Outcome Measure

Two-year progression-free survival rate [ Time Frame: 2 years ]

Central Contacts

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