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Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP InhibitorPhase 2NIRVANA-RNCT04734665

Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

A Phase 2 study testing Niraparib-Bevacizumab in people with Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor, run by Yonsei University at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is phase II, open label, clinical trial to determine the efficacy of Niraparib re-treatment with Bevacizumab of assessment progression-free survival(6 months PFS rate) with platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor. Read more about this study

Who is it for?
Ages 20 years and older, women only
What is being tested?
Niraparib-Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSouth Korea
Study dates
5 Jul 2021to 31 Mar 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 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 4 patients with clear cell carcinoma will be included and mucinous carcinoma will not be included).
  • Participant has received at least 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 12 months' period between penultimate platinum regimen and progression of disease) Note: The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria.
  • 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 had prior treatment with PARP inhibitor
  • 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 on the day of signing informed consent with
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  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
  • Female participants:
  • A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
  • A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days following the last dose of niraparib and at least 210 days following the last dose of chemotherapy or bevacizumab.
  • Informed Consent
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research.
  • Participant has adequate organ function as defined in the following contents; all screening laboratory tests should be performed within 10 days prior to the start of study treatment.
  • Absolute neutrophil count (ANC) ≥1500/µL
  • Platelets ≥100 000/µL
  • Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La
  • Creatinine OR Measured or calculated creatinine clearance(GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
  • Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
  • AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
  • 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

Who cannot join

  • Participant has mucinous, germ cell, or borderline tumor of the ovary.
  • 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 2 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carinoma) that have undergone potentially curative therapy are not excluded.
  • Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion.
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  • Drainage of ascites during last 2 cycles of last chemotherapy.
  • Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
  • Persistent > grade 2 toxicity from prior cancer therapy.
  • Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  • Known hypersensitivity to the components of niraparib.
  • Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  • History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study treatment, or is not in the best interest of the patient to participate.
  • Immunocompromised patients.
  • Patients with known active hepatic disease (i.e. , Hepatitis B or C).

Trial locations and contacts

1 site in 1 country.

Jung Yun Lee contact

82-2-2228-2237

jungyunlee@yuhs.ac

South Korea1 site, 1 recruiting

  • Yonsei University College of Medicine

    Seoul, 03722

    Jung Yun Lee, 82-2-2228-2237, jungyunlee@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: A Single-arm Phase II Study of Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

This study is phase II, open label, clinical trial to determine the efficacy of Niraparib re-treatment with Bevacizumab of assessment progression-free survival(6 months PFS rate) with platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor.

Read the detailed description

This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Niraparib re-treatment with Bevacizumab of assessment progression-free survival(6 months PFS rate) with platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor 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:

  • Niraparib 200mg or 300mg (once daily[QD])*
  • Bevacizumab 15mg/kg every 3 weeks (Q3W)
  • The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.
Being tested
Niraparib-Bevacizumab
Keywords
ovarian cancer, Platinum-sensitive, PARP inhibitor
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Niraparib-BevacizumabDrug

    Niraparib 200mg or 300mg (once daily[QD]) Bevacizumab 15mg/kg every 3 weeks (Q3W)

    *The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.

Study groups in NCT04734665
Study groupRoleWhat they receive
experimentalExperimentalPlatinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor, Non-mucinous
Receives: Drug: Niraparib-Bevacizumab

What is being measured

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

  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)

    Measured: 6 months

Secondary outcomes (5)

  1. Overall survival (OS)

    Measured: Up to 1year

  2. Time to tumour progression (TTP)

    Measured: Up to 1year

  3. Time to first subsequent treatment(or death)

    Measured: The date of first documented first subsequent treatment or date of death, assessed up to 36months

  4. Time to second subsequent treatment

    Measured: The date of first documented second subsequent treatment assessed up to 36months

  5. progression-free survival

    Measured: Up to 1year

Timeline

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

  1. First posted2 Feb 2021
  2. Study start5 Jul 2021
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Mar 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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04734665
Sponsor's protocol ID
4-2021-0076
Acronym
NIRVANA-R
Status last verified
Jul 2021
First submitted
28 Jan 2021
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: (Describe the IPD sharing plan, including what IPD are to be shared with other researchers.)

Publications

  • Park J, Lim MC, Lee JK, Jeong DH, Kim SI, Choi MC, Kim BG, Lee JY. A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial. J Gynecol Oncol. 2022 Mar;33(2):e12. doi: 10.3802/jgo.2022.33.e12. Epub 2021 Dec 6.

    PubMed 34910393

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib-Bevacizumab in people with Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor, run by Yonsei University at 1 site in South Korea.

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 21 inclusion and 16 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 12 Jul 2021. 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 South Korea. 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 Jung Yun Lee (82-2-2228-2237, jungyunlee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival(6 months PFS rate) (time frame: 6 months). 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 NCT04734665, which also lists 1 linked publication.

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 12 Jul 2021.

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