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Ovarian CancerPhase 3NCT05009082

Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

A Phase 3 study testing Carboplatin, Paclitaxel and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by AGO Study Group at 65 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, Paclitaxel and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
970 participants
Where
65 sitesGermany
Study dates
13 Sep 2022to Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the clinical trial requirements.
  • Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO stage IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO stage IIIB - IV according to FIGO 2009 classification).
  • All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.
  • Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of BRCA status prior to randomization for stratification.
  • Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
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  • Estimated life expectancy > 3 months.
  • Adequate bone marrow function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L
  • Platelets (PLT) ≥ 100 x 10^9/L
  • Hemoglobin (Hb) ≥ 9 g/dL (can be post-transfusion)
  • Adequate coagulation parameters (within 28 days prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2)
  • Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x institutional upper limit of normal (ULN).
  • The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least one week at the time of randomization.
  • Adequate liver and kidney function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)
  • Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) OR direct bilirubin ≤ 1.0 x ULN.
  • Aspartate aminotransferase / Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase / Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN.
  • Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
  • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 30 mL/min (see Appendix 2).
  • Patients must have normal blood pressure (BP) or adequately treated and controlled BP, with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 4 weeks prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2.
  • Negative urine or serum pregnancy test within 7 days prior to day 1, cycle 1 in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after administration of the last dose of medication.
  • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus).
  • Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other clinical trial procedures, that include the completion of patient-reported outcomes questionnaires.

Who cannot join

  • Non-epithelial tumor origin of the ovary.
  • Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors.
  • Planned intraperitoneal cytotoxic chemotherapy.
  • Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or stage I p53 wild type endometrial cancer).
  • Prior systemic treatment for ovarian cancer.
  • Prior treatment with Poly adenosine diphosphate ribose polymerase (PARP) inhibitor.
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  • Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
  • Prior randomization in this trial.
  • Major surgery within 1 week of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.
  • History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected spinal cord compression.
  • Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab.
  • Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to day 1, cycle 1.
  • History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to day 1, cycle 1.
  • History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures.
  • Pregnant or lactating women.
  • Treatment with any other investigational agent, or participation in another clinical trial testing a drug within 4 weeks or 5 times the half-life of the drug, whichever is longer, prior to day 1, cycle 1 or concomitantly within this trial.
  • Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanized antibodies. Known hypersensitivity to niraparib, paclitaxel and carboplatin and its components or excipients.
  • Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no severe evidence of facial dehiscence or infection are eligible; regular wound examination will be performed.
  • Clinically significant cardiovascular disease, including
  • Myocardial infarction or unstable angina within 6 months of day 1, cycle 1
  • New York Heart Association (NYHA) Grade 2 Congestive Heart Failure (CHF),
  • Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
  • Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activity of daily living (ADL) requiring repair or revision)
  • Significant vascular disease including aortic aneurysm requiring surgical repair
  • Pre-existing sensory or motor neuropathy ≥ Grade 2.
  • (Intentionally left blank)
  • Patients with a history of or current Nephrotic syndrome.
  • Persistent cancer-related bowel obstruction (including subocclusive disease). Patients with a known history of ileus, who have been successfully treated and who are free of symptoms, may be eligible after consultation of sponsor.
  • History of abdominal fistula or tracheoesophageal fistula or gastrointestinal perforation or active gastrointestinal bleeding or anastomotic insufficiency within 6 months of day 1, cycle 1.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of niraparib.
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
  • Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Previous allogeneic bone marrow transplant or previous solid organ transplantation.
  • Current or recent (within 10 days prior to day 1, cycle 1) chronic use of aspirin > 325 mg/day. Patients treated with other inhibitors of platelet aggregation such as clopidogrel, prasugrel, ticlopidine, tirofibane or dipyridamole should not be included into the trial.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.
  • Patient has known active hepatitis B or hepatitis C.
  • Patient has a history of Posterior Reversible Encephalopathy Syndrome (PRES).
  • Patients with chronic inflammatory bowel disease and active treatment for disease control.

Trial locations and contacts

65 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra Polleis contact

+49 611 880467 ext. 40

spolleis@ago-ovar.de

65 sites in 1 country

Germany65 sites, 65 recruiting

  • Klinikum St. Marien Amberg

    Amberg

    Recruiting

  • Klinikum Augsburg

    Augsburg

    Recruiting

  • Hochtaunus-Kliniken

    Bad Homburg

    Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin

    Recruiting

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld

    Recruiting

  • Städt. Klinikum Brandenburg

    Brandenburg an der Havel

    Recruiting

  • Klinikum Bremen Mitte

    Bremen

    Recruiting

  • Klinikum Chemnitz

    Chemnitz

    Recruiting

  • St. Elisabeth-Krankenhaus Köln-Hohenlind

    Cologne

    Recruiting

  • Klinikum Dortmund

    Dortmund

    Recruiting

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

    Recruiting

  • Florence-Nightingale-Krankenhaus Düsseldorf

    Düsseldorf

    Not yet recruiting

  • Universitätsfrauenklinik Düsseldorf

    Düsseldorf

    Recruiting

  • KEM Essen | Evang. Kliniken Essen-Mitte gGmbH

    Essen

    Recruiting

  • Universitätsklinikum Essen

    Essen

    Recruiting

  • Klinikum Esslingen GmbH

    Esslingen am Neckar

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt

    Recruiting

  • Klinikum Frankfurt Höchst

    Frankfurt am Main

    Recruiting

  • Universitätsklinikum Gießen

    Giessen

    Recruiting

  • Klinikum Gütersloh

    Gütersloh

    Recruiting

  • Universitätsklinikum Halle

    Halle

    Recruiting

  • Albertinen Krankenhaus

    Hamburg

    Recruiting

  • Mammazentrum HH am Krankenhaus Jerusalem

    Hamburg

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Recruiting

  • Gynäkologisch-Onkologische Praxis am Pelikanplatz

    Hanover

    Recruiting

  • Universitätsklnikum Heidelberg

    Heidelberg

    Recruiting

  • Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH

    Heilbronn

    Recruiting

  • Gyn.-onkolog. Gemeinschaftspraxis Hildesheim

    Hildesheim

    Recruiting

  • Universtitätsklinikum Jena

    Jena

    Recruiting

  • Städtisches Klinikum Karlsruhe

    Karlsruhe

    Recruiting

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe

    Recruiting

  • Klinikum Kassel

    Kassel

    Recruiting

  • Klinikverbund Kempten-Oberallgäu gGmbH

    Kempten

    Not yet recruiting

  • Klinikum Konstanz

    Konstanz

    Not yet recruiting

  • Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld

    Krefeld

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig

    Recruiting

  • St. Vincenz Krankenhaus

    Limburg

    Recruiting

  • UKSH Campus Lübeck

    Lübeck

    Recruiting

  • Klinikum Ludwigsburg

    Ludwigsburg

    Recruiting

  • Universitätsmedizin Mainz

    Mainz

    Recruiting

  • Universitätsklinikum Mannheim GmbH

    Mannheim

    Recruiting

  • UKGM Gießen/Marburg Standort Marburg

    Marburg

    Recruiting

  • Mühlenkreiskliniken, Johannes Wesling Klinikum Minden

    Minden

    Recruiting

  • LMU Klinikum München-Großhadern

    München

    Recruiting

  • Rotkreuzklinikum München

    München

    Recruiting

  • Universitätsklinikum Münster

    Münster

    Recruiting

  • Klinikum Neumarkt

    Neumarkt

    Recruiting

  • MVZ Nordhausen

    Nordhausen

    Recruiting

  • Ortenau Klinikum Offenburg-Kehl

    Offenburg

    Recruiting

  • St. Vincenz Krankenhaus GmbH

    Paderborn

    Recruiting

  • Studienzentrum Onkologie Ravensburg

    Ravensburg

    Recruiting

  • Krankenhaus Barmherzige Brüder

    Regensburg

    Recruiting

  • Klinikum am Steinenberg

    Reutlingen

    Recruiting

  • RoMed Klinikum Rosenheim

    Rosenheim

    Recruiting

  • Klinikum Südstadt Rostock

    Rostock

    Recruiting

  • Thüringen-Kliniken "Georgius Agricola"

    Saalfeld

    Recruiting

  • Leopoldina Krankenhaus Schweinfurt

    Schweinfurt

    Recruiting

  • g.SUND

    Stralsund

    Recruiting

  • Klinikum Stuttgart

    Stuttgart

    Recruiting

  • Klinikum Traunstein

    Traunstein

    Recruiting

  • Klinikum Mutterhaus

    Trier

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen

    Recruiting

  • Universitätsklinik Ulm

    Ulm

    Recruiting

  • St. Josefs-Hospital

    Wiesbaden

    Recruiting

  • Klinikum Worms

    Worms

    Recruiting

Other trials in Germany

About this study

Official title: Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)

This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.

Read the detailed description

Eligible patients will be those patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III/IV, except FIGO stage IIIA2 without nodal involvement) invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, who have either undergone upfront primary surgery or plan to undergo chemotherapy with interval debulking surgery (IDS). In addition, patients should not have any medical contraindications that would exclude treatment with bevacizumab and/or niraparib.

All eligible patients will receive the first cycle of chemotherapy (carboplatin area under curve [AUC] 5 and paclitaxel 175 mg/m²) as part of Study Run-In-Period (cycle 1). In parallel, central laboratory will determine the breast cancer (BRCA) status in tumor tissue (tBRCA). All patients with a valid central tBRCA test result will be randomized within 3 days prior to day 1 of cycle 2 in a 1:1 ratio in the following treatment arms:

Arm 1: Patients will receive further 5 cycles of carboplatin and paclitaxel q21d followed by niraparib once daily for up to a total of 3 years

Arm 2: Patients will receive further 5 cycles of carboplatin and paclitaxel plus bevacizumab q21d followed by bevacizumab q21d (for up to 1 year) and niraparib once daily for up to a total of 3 years.

The study aims to investigate, if the treatment strategy of carboplatin / paclitaxel / bevacizumab / niraparib is superior to the treatment of carboplatin / paclitaxel / niraparib-Inhibitor in an all-comer population.

Keywords
High Grade Epithelial Ovarian Cancer, Advanced Ovarian Cancer, Niraparib, Bevacizumab, Carboplatin, Paclitaxel
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • CarboplatinDrug

    Area under curve (AUC) 5, intravenous, on day 1 every 3 weeks for 6 cycles

  • PaclitaxelDrug

    175 mg/m², intravenous, on day 1 every 3 weeks for 6 cycles

  • BevacizumabDrug

    7.5 mg/kg or 15 mg/kg (according to local standard), intravenous, on day 1 every 3 weeks starting from cycle 2 in combination with chemotherapy and thereafter for up to 1 year starting from Cycle 7 Day 1

  • NiraparibDrug

    200 or 300 mg capsules once daily for up to a total of 3 years starting from Cycle 7 Day 1

Study groups in NCT05009082
Study groupRoleWhat they receive
Arm 1Active comparatorChemotherapy followed by maintenance with niraparib
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Niraparib
Arm 2Active comparatorChemotherapy in combination with bevacizumab followed by maintenance with bevacizumab and niraparib
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Niraparib

What is being measured

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

  1. Progression Free Survival (PFS)

    Defined as the time from randomization to first progressive disease (PD) or death, whichever occurs earlier. PD is based on investigators assessment using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

    Measured: Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier

Secondary outcomes (7)

  1. PFS according to tumor BRCA status

    Defined as the time from randomization to first progressive disease (PD) or death, whichever occurs earlier. PD is based on investigators assessment using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

    Measured: Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier

  2. Overall Survival (OS)

    Defined as the time from randomization to death

    Measured: at every visit during the trial up to 66 months after Last Patient In

  3. Time to First Subsequent Therapy (TFST)

    Defined as the time from randomization to the first subsequent treatment or death, whichever occurs earlier

    Measured: at every visit during the trial up to 66 months after Last Patient In

  4. Second Progression (PFS 2)

    Defined as the time from randomization to the second progression or death, whichever occurs earlier

    Measured: at every visit during the trial up to 66 months after Last Patient In

  5. Time to Second Subsequent Therapy (TSST)

    Defined as the time from randomization to the second subsequent treatment death whichever occurs earlier

    Measured: at every visit during the trial up to 66 months after Last Patient In

  6. Number of participants with treatment-related adverse events (AE) and/or serious adverse events (SAEs) and/or AEs that led to premature withdrawal of trial treatment and/or interruptions/dose modifications

    Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: at every visit during the trial up to safety follow up visit 30 days after last dose

  7. Effects on Quality of Life (QoL)

    Questionnaires to be completed by patients and collected frequently during the trial

    Measured: Assessed frequently during the trial up to 66 months after Last Patient In

Timeline

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

  1. First posted17 Aug 2021
  2. Study start13 Sep 2022
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2031 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
970 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009082
Sponsor's protocol ID
AGO-OVAR 28
Other IDs
2024-516066-11-00, 2021-001271-16, ENGOT-ov57
Status last verified
Sep 2025
First submitted
2 Aug 2021
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Heitz F, Marth C, Henry S, Reuss A, Cibula D, Gaba Garcia L, Colombo N, Schmalfeld B, de Gregorio N, Wimberger P, Hasenburg A, Sehouli J, Gropp-Meier M, Schouten PC, Hahnen E, Hauke J, Polleis S, Harter P. AGO-OVAR 28/ENGOT-ov57. Niraparib alone versus niraparib in combination with bevacizumab in patients with carboplatin-taxane-based chemotherapy in advanced ovarian cancer: a multicenter randomized phase III trial. Int J Gynecol Cancer. 2023 Dec 4;33(12):1966-1969. doi: 10.1136/ijgc-2023-004944.

    PubMed 37935524

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Paclitaxel and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by AGO Study Group at 65 sites in Germany.

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 25 inclusion and 38 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Sandra Polleis (+49 611 880467 ext. 40, spolleis@ago-ovar.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier). 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 NCT05009082, which also lists 2 linked publications.

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 10 Sep 2025.

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