NCT05158062

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

November 26, 2021

Last Update Submit

April 25, 2022

Conditions

Carcinoma, Ovarian Epithelial

Keywords

ovarian cancer, pembrolizumab, olaparib

Outcome Measures

Primary Outcomes (1)

  • Two-year progression-free survival rate

    Two-year progression-free survival rate after administration of pembrolizumab and bevacizumab in combination with PBC followed by pembrolizumab, bevacizumab and olaparib as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer based on RECIST 1.1.

    2 years

Secondary Outcomes (8)

  • Progression-Free Survival (PFS)

    3 years

  • PFS in maintenance period by chemotherapy responder

    3 years

  • Objective Response Rate (ORR)

    3 years

  • Disease Control Rate (DCR)

    3 years

  • Duration of Response (DOR)

    3 years

  • +3 more secondary outcomes

Other Outcomes (1)

  • Biomarkers

    3 years

Study Arms (1)

pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib

EXPERIMENTAL

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.

Biological: pembrolizumabDrug: olaparibBiological: bevacizumabDrug: carboplatinDrug: paclitaxelDrug: docetaxel

Interventions

pembrolizumabBIOLOGICAL

pembrolizumab 200 mg every three weeks (Q3W)

Also known as: KEYTRUDA
pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib
olaparibDRUG

olaparib 300 mg twice daily (BID) during maintenance period

Also known as: LYNPARZA
pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib
bevacizumabBIOLOGICAL

bevacizumab 15 mg/kg Q3W

Also known as: AVASTIN
pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib
carboplatinDRUG

carboplatin AUC=5 or 6 Q3W during treatment period

pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib
paclitaxelDRUG

paclitaxel 175 mg/m2 Q3W during treatment period

pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib
docetaxelDRUG

docetaxel 60 \~ 70 mg/m2 Q3W during treatment period

pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is at least 20 years of age on the day of signing informed consent with histologically confirmed epithelial ovarian cancer (excluding borderline ovarian tumor) excluding mucinous carcinoma.
  • Participant has received only one regimen of PBC (3 cycles or more) as prior therapy with clinical CR (determined by negative clinical examination and a normal CA-125 level).
  • Participant has documentation of progressive disease at least 6 months from completion of PBC (platinum-sensitive).
  • Participant with measurable disease based on RECIST 1.1 at screening
  • Participant is able to provide a core or excisional biopsy of a tumor for testing of PD-L1 status, etc.
  • Participant with Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 at the screening
  • Participant has a life expectancy of at least 12 weeks as determined by the investigators.
  • Participant has adequate organ function.

You may not qualify if:

  • A Women of Childbearing Potential (WOCBP) who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Participant has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the first dose of study drug.
  • Participant has received prior radiotherapy within 2 weeks of the first dose of study drug.
  • Participant has received major surgery within 4 weeks prior to the first dose of study drug.
  • Participant has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
  • Participant is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug.
  • Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • 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 severe hypersensitivity (≥Grade 3) to the study treatment and/or any of its excipients.
  • Participant has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Participant has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with steroids or has current pneumonitis/interstitial lung disease.
  • Participant has an active infection requiring systemic therapy.
  • Participant has a known history of Human Immunodeficiency Virus (HIV) infection.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saitama Medical Uiversity International Medical Center

Hidaka, Saitama, 3501298, Japan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialOvarian Neoplasms

Interventions

pembrolizumabolaparibBevacizumabCarboplatinPaclitaxelDocetaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Kosei Hasegawa, MD, PhD

    Saitama Medical University International Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kosei Hasegawa, MD, PhD

CONTACT

+81-42-984-4111koseih@saitama-med.ac.jp

Miwa Hirai

CONTACT

+81-3-6779-8222saint-ov02@cmic.co.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Director, Department of Gynecologic Oncology

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 15, 2021

Study Start

April 20, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)