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Carcinoma, Ovarian EpithelialPhase 2NCT05158062

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

A Phase 2 study testing pembrolizumab, olaparib and bevacizumab in people with Carcinoma, Ovarian Epithelial, run by Kosei Hasegawa, MD, PhD at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Carcinoma, Ovarian Epithelial
What is being tested?
pembrolizumab, olaparib and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteJapan
Study dates
20 Apr 2022to 30 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.
  • Participant has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Participant has received colony-stimulating factors (granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study drug.
  • Participant has clinically serious cardiovascular/cerebrovascular diseases (eg, cerebrovascular accident/stroke [less than 6 month prior to enrollment], myocardial infarction [less than 6 month prior to enrollment], uncontrolled and potentially reversible cardiac conditions [unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 msec, electrolyte disturbances, hypertension defined as systolic >150 mmHg or diastolic >90 mmHg etc.] or participant has congenital long QT syndrome).
  • Participant has known abdominal fistula, gastrointestinal fistula or gastrointestinal perforation and/or higher risks of bleeding.
  • Participant has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
  • Participant is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued prior to the first dose of study drug.
  • Participant is currently receiving either strong (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued prior to the first dose of study drug.
  • Participant is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).
  • Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 210 days after the last dose of study treatment.
  • Participant has had an allogenic tissue/solid organ transplant.
  • Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigators.

Trial locations and contacts

1 site in 1 country.

Kosei Hasegawa, MD, PhD contact

+81-42-984-4111 ext. 5627

koseih@saitama-med.ac.jp

Miwa Hirai contact

+81-3-6779-8222

saint-ov02@cmic.co.jp

Japan1 site, 1 recruiting

  • Saitama Medical Uiversity International Medical Center

    Hidaka, Saitama, 3501298

    Kosei Hasegawa, MD, +81-42-984-4641, koseih@saitama-med.ac.jp

    Kosei Hasegawa, MD

    Recruiting

Other trials in Japan

About this study

Official title: Phase II Study of Pembrolizumab and Bevacizumab in Combination With Platinum-based Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Patients With Platinum-sensitive Recurrent Ovarian Cancer

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.

Keywords
ovarian cancer, pembrolizumab, olaparib
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumabBiological

    Also called KEYTRUDA

    pembrolizumab 200 mg every three weeks (Q3W)

  • olaparibDrug

    Also called LYNPARZA

    olaparib 300 mg twice daily (BID) during maintenance period

  • bevacizumabBiological

    Also called AVASTIN

    bevacizumab 15 mg/kg Q3W

  • carboplatinDrug

    carboplatin AUC=5 or 6 Q3W during treatment period

  • paclitaxelDrug

    paclitaxel 175 mg/m2 Q3W during treatment period

  • docetaxelDrug

    docetaxel 60 ~ 70 mg/m2 Q3W during treatment period

Study groups in NCT05158062
Study groupRoleWhat they receive
pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparibExperimentalParticipants 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.
Receives: Biological: pembrolizumab; Drug: olaparib; Biological: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (8)

  1. Progression-Free Survival (PFS)

    PFS after administration of the study treatment based on RECIST 1.1

    Measured: 3 years

  2. PFS in maintenance period by chemotherapy responder

    PFS in maintenance period in patients who assessed CR or PR at last tumor assessment before entering maintenance period based on RECIST 1.1

    Measured: 3 years

  3. Objective Response Rate (ORR)

    ORR after administration of the study treatment based on RECIST 1.1

    Measured: 3 years

  4. Disease Control Rate (DCR)

    DCR after administration of the study treatment based on RECIST 1.1

    Measured: 3 years

  5. Duration of Response (DOR)

    DOR after administration of the study treatment based on RECIST 1.1

    Measured: 3 years

  6. One-year progression-free survival rate

    One-year progression-free survival rate after administration of the study treatment based on RECIST 1.1.

    Measured: 1 year

  7. Overall Survival (OS)

    OS after administration of the study treatment using Kaplan-Meier method

    Measured: 3 years

  8. Incidence of adverse events

    The number and proportion of participants with adverse events as assessed by CTCAE v5.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start20 Apr 2022
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05158062
Sponsor's protocol ID
SaINT-ov02
Status last verified
Apr 2022
First submitted
26 Nov 2021
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pembrolizumab, olaparib and bevacizumab in people with Carcinoma, Ovarian Epithelial, run by Kosei Hasegawa, MD, PhD at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kosei Hasegawa, MD, PhD (+81-42-984-4111 ext. 5627, koseih@saitama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two-year progression-free survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05158062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.

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