ClinicalTrials.gg
Status unknownNCT04361370OPEB-01Updated Apr 19, 2021

Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer

A Phase 2 interventional study of Olaparib-Pembrolizumab-Bevacizumab in Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
20 Years and older
Sex
Female
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Study summary

This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.

Read the detailed description

'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with platinum-sensitive who have received prior of platinum-based chemotherapy. The study will assess the effectiveness of progression-free survival(6 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated to until disease progression as below:

  • Maintenance : Olaparib 300mg (twice daily [BID])
  • Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions
  • Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)
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Conditions studied

  • Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer

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Keywords

  • BRCA wild type
  • ovarian cancer
  • Platinum-sensitive
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

This study's planned enrollment of 44 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant has histologically confirmed diagnosis of high-grade predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC, primary peritoneal cancer, or fallopian tube cancer will be enrolled in this study (only up to 8 patients with clear cell carcinoma will be included and mucinous carcinoma will not be included).
  • Participant has received 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 months' period between penultimate platinum regimen and progression of disease
  • Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
  • Participant is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA 1/2 and PD-L1 status prior to enrollment
  • Female participants who are at least 20 years of age and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Participant has adequate organ function as defined in the following:

    1. ANC≥1500/µL
    2. PLT≥100 000/µL
    3. Hemoglobin≥9.0 g/dL or ≥5.6 mmol/L
    4. Creatinine≤1.5 × ULN or calculated creatinine clearance≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
    5. Total bilirubin≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
    6. AST (SGOT) and ALT (SGPT)≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
    7. International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT)≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

Exclusion criteria

Exclusion Criteria:

  • Participant has mucinous, germ cell, or borderline tumor of the ovary
  • Participant has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
  • Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
  • Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML
  • 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 a known history of active TB (Bacillus Tuberculosis)
  • 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 uncontrolled hypertension, defined as systolic > 140 mmHg or diastolic > 90 mmHg documented by 2 blood pressure readings taken at least 1 hour apart
  • Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to randomization
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Treatment group

    BRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer

    Drug: Olaparib-Pembrolizumab-Bevacizumab

Interventions

  • DrugOlaparib-Pembrolizumab-Bevacizumab

    * Olaparib 300mg (twice daily \[BID\]) * Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions * Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)

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What researchers measure

Primary outcomes

  1. progression-free survival(6 months PFS rate)

    To determine the clinical effectiveness of the study treatment assessed using progression free survival(6months) according to RECIST v1.1 criteria (Investigator determined)

    Time frame: 6 months

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 1year

  2. Time to tumour progression (TTP)

    Time frame: Up to 1year

  3. Time to first subsequent treatment(or death)

    Time frame: The date of first documented first subsequent treatment or date of death, assessed up to 72 months

  4. Time to second subsequent treatment

    Time frame: The date of first documented second subsequent treatment assessed up to 72 months

  5. progression-free survival

    Time frame: Up to 1year

07

Study locations

1 site
  • Yonsei Severance Hospital
    Seoul, South Korea
08

References and documents

Publications

  • Lee YJ, Lim MC, Kim BG, Ngoi NY, Choi CH, Park SY, Tan DS, Go Y, Lee JY. A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01). J Gynecol Oncol. 2021 Mar;32(2):e31. doi: 10.3802/jgo.2021.32.e31. Epub 2021 Jan 27. PubMed 33559413 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for May 2026, 67 months after the start.

Of 203 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 67 months is above that.

Counting every sponsor, half of 307 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2020
First posted
Apr 24, 2020
StartActual
Oct 28, 2020
Primary completionEst.
May 2026
CompletionEst.
Aug 2026
Last update
Apr 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04361370
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 24, 2020
Start date
Oct 28, 2020
Primary completion
May 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Apr 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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