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Ovarian CancerPhase 2OLAPemNCT04417192

Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer

A Phase 2 study testing Olaparib and Pembrolizumab in people with Ovarian Cancer, run by National Cancer Center Hospital East at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Olaparib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesJapan
Study dates
1 Dec 2020to 30 Jun 2023
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

  • Has given signed informed consent to participate in the clinical trial of her own will.
  • Is aged 20 years or older on the day of signing the informed consent.
  • Has been diagnosed with histologically confirmed, Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by the International Federation of Gynecology and Obstetrics (FIGO) staging system (2014), with a histological type of high-grade serous or Grade 3 endometrioid carcinoma.
  • Have measurable disease based on RECIST 1.1.
  • Is a candidate for debulking surgery.
  • Has an HRD-positive tumor.
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  • Has an ECOG Performance Status of 0 or 1.
  • Laboratory test results within 21 days prior to enrollment have met the following organ function criteria. However, measurements within 14 days of blood transfusion or administration of granulocyte-colony stimulating factor (G-CSF) are excluded.
  • Neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL
  • Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min
  • T-Bil ≤ 2.0 mg/dL
  • ALT and AST ≤ 100 U/L (≤ 200 U/L if liver metastasis is present)
  • A woman of childbearing potential must agree to use contraception after signing the informed consent, throughout the study period, and until at least 120 days following the last dose of the study drug

Who cannot join

  • Has received previous allogeneic bone-marrow transplantation.
  • Has concurrent interstitial lung disease/pneumonitis, or a history of (noninfectious) interstitial lung disease/pneumonitis that required treatment with steroids. Interstitial lung disease/pneumonitis includes radiation pneumonitis.
  • Has received prior antitumor therapy (e.g., chemotherapy, molecular-targeted therapy, therapeutic antibody, endocrine therapy, immunotherapy, and investigational therapy).
  • Has received surgery under general anesthesia within 28 days prior to enrollment. However, surgery to diagnose ovarian/fallopian tube/peritoneal cancer performed under general anesthesia is allowed.
  • Has received radiation or radioactive isotope therapy within 28 days prior to enrollment.
  • Has uncontrolled pericardial effusion, pleural effusion, or peritoneal effusion.
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  • Has a history of cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia within 180 days prior to enrollment.
  • Has a history of deep vein thrombosis or pulmonary embolism.
  • Is receiving systemic glucocorticoid therapy or systemic immunosuppressive therapy.
  • Has a history of autoimmune disease.
  • Is infected with human immunodeficiency virus (HIV).
  • Is infected with active* hepatitis B or hepatitis C.
  • : Active hepatitis B is defined as HBs antigen positive.
  • Has a symptomatic infection within 14 days prior to enrollment.
  • Has received a live vaccine within 28 days prior to enrollment.
  • Has clinically critical cardiac disease (has a history of myocardial infarction or angina pectoris within 180 days prior to enrollment or has New York Heart Association [NYHA] class II or higher cardiac failure, uncontrolled arrhythmia, or QTc prolongation defined as QTc > 470 msec).
  • Has active brain metastasis or a tumor causing spinal cord compression.
  • Is pregnant or breastfeeding.
  • Has a history of severe allergy, anaphylaxis, or hypersensitivity induced by humanized chimeric antibodies.
  • Is allergic to biologics produced from Chinese hamster ovary (CHO) cells, carboplatin, or paclitaxel.
  • Has a known or suspected active malignancy that is different from the disease of interest in the clinical trial or has a history of other malignancy within 3 years prior to enrollment. However, cutaneous basal cell carcinoma and cervical carcinoma in situ are not part of this exclusion criterion.
  • Is unwilling to or unable to comply with the protocol.
  • Is not eligible to enroll in the clinical trial based on the judgment by the Investigator or Sub-investigator.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • National Cancer Center Hospital East

    Kashiwa, Chiba

  • Kurume University Hospital

    Kurume, Fukuoka

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime

Other trials in Japan

About this study

Official title: A Pilot Study to Evaluate the Efficacy and Safety of Preoperative Olaparib Monotherapy and Preoperative Olaparib Plus Pembrolizumab Combination Therapy in Patients With HRD-Positive Stage III or IV Advanced Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer

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.

Read the detailed description

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 HRD positivity. The first cohort (Olaparib monotherapy : 10 cases) will be evaluated for the presence or absence of immune cell activation, and the tumor reduction effect will be evaluated in the second cohort (Olaparib plus pembrolizumab combination therapy : 20 cases).

Conditions
Ovarian Cancer
Being tested
Olaparib, Pembrolizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • OlaparibDrug

    Olaparib will be administered at a dose of 300mg as oral dose, twice a day.

  • PembrolizumabDrug

    Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).

Study groups in NCT04417192
Study groupRoleWhat they receive
Olaparib or Olaparib Plus PembrolizumabExperimentalCohort 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.
Receives: Drug: Olaparib; Drug: Pembrolizumab

What is being measured

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

  1. Objective response rate (ORR)

    Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1.

    Measured: 6 weeks

Secondary outcomes (4)

  1. The incidence of adverse events

    The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days after the last dose

  2. Chemotherapy response score (CRS)

    To evaluate the effect of histopathological treatment on patients with serous carcinoma and metastasis to the omentum. The histopathological treatment effect is determined according to the chemotherapy response score (CRS)

    Measured: 6 months from the end of registration

  3. Progression-free survival (PFS)

    PFS is defined as the time from the first dose to the earlier of progression assessed by the Investigator per RECIST v. 1.1 (PD) or clinical criteria, or death due to any cause.

    Measured: 6 months from the end of registration

  4. Overall survival (OS)

    OS is defined as the time from the first dose to death due to any cause.

    Measured: 6 months from the end of registration

Timeline

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

  1. First posted4 Jun 2020
  2. Study start1 Dec 2020
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

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
Model description
This study has 2 cohorts. Cohort 1 is Olaparib monotherapy Cohort 2 is Olaparib plus Pembrolizumab combination therapy
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417192
Sponsor's protocol ID
EPOC1903
Acronym
OLAPem
Status last verified
Jul 2023
First submitted
2 Jun 2020
Last updated
6 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib and Pembrolizumab in people with Ovarian Cancer, run by National Cancer Center Hospital East at 3 sites 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 15 inclusion and 23 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: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 6 weeks). 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 NCT04417192.

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 6 Jul 2023.

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