New trial tests drug combo to keep ovarian cancer at bay

NCT ID NCT05183984

Disease control Sponsor: ARCAGY/ GINECO GROUP Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for women with advanced ovarian cancer who have had complete surgery and chemotherapy. It compares two maintenance treatments: niraparib alone versus niraparib plus bevacizumab. The goal is to see which approach better delays cancer progression. About 390 participants will be followed for up to 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: niraparib and bevacizumab
What this could lead to: If successful, this could show that adding bevacizumab to niraparib maintenance helps keep ovarian cancer from returning longer than niraparib alone.
What could go wrong: This is a phase 2 trial, so results are still early. The combination may not improve outcomes and could increase side effects like high blood pressure or fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For inclusion in the study, patient should fulfill the following criteria: 1. Female patient ≥ 18 years of age. 2. Signed informed consent and ability to comply with treatment and follow-up. 3. Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings): • high grade serous or * high grade endometrioid (grade 2 and 3) or * other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification. 4. Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Patient must have received one cycle of carboplatin AUC 5-6 + paclitaxel 175 mg/m² 7. Patient must have started cycle 1 chemotherapy no later than 6 weeks after surgery. 8. Patient must have a thorax-abdomen-pelvis CT scan between surgery and Cycle 1, with no evidence of disease. 9. Patient eligible for first line platinum-taxane chemotherapy: 10. Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months. 11. Patient must have normal organ and bone marrow function before first cycle of chemotherapy: * Hemoglobin ≥ 9.0 g/dL. * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. * Platelet count ≥ 100 x 109/L. * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). * Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN. * Serum creatinine ≤ 1. 5 x institutional ULN and GFR \> 50 mL/min, by using an exact measure (ie. Iohexol clearance) or the most appropriate formula (Jeliffe, Cockroft Gault, MDRD, CKD-EPI) to the investigator's discretion. * Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≥1.5 and an Activated ProThrombin Time (aPTT) ≥1.5 x 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 site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization. 12. Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥2+, 24-hour proteinuria must be \<1 g. 13. Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg). 14. Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional). 15. For countries where this will apply to: a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of a social security category. Exclusion Criteria: * 1\. Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors). 2\. Ovarian tumor of low malignant potential (e.g. borderline tumor), or mucinous carcinoma. 3\. Patient with a diagnosis, detection, or treatment of another type of cancer ≤ 3 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated and synchronous grade 1 stage 1 endometrial cancer) Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment. 4\. Patient with synchronous high grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible. 5\. Patient with myelodysplastic syndrome/acute myeloid leukemia history. 6. Patient receiving radiotherapy within 6 weeks prior to study treatment. 7. Previous allogenic bone marrow transplant. 8. Any previous treatment with PARP inhibitor. 9. Administration of other simultaneous chemotherapy drugs - except during a HIPEC procedure with cisplatin at PDS, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroid antiemetics). 10\. Current or recent (within 10 days prior to randomization) chronic use of aspirin \> 325 mg/day. 11\. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy. 12\. Clinically significant (e.g. active) cardiovascular disease, including: * Myocardial infarction or unstable angina within ≤ 6 months of randomization, * New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF), * Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG. * Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living \[ADL\] requiring repair or revision). 13\. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA), Sub- Arachnoids Hemorrhage (SAH) or Posterior Reversible Encephalopathy Syndrome (PRES). 14\. History or evidence of hemorrhagic disorders. 15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation). 16\. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression. 17\. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures). 18\. Significant traumatic injury during 4 weeks prior to randomization. 19. Non-healing wound, active ulcer, or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations. 20\. History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment. 21\. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease. 22\. Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure. 23\. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications. 24\. Pregnant or lactating women. 25. Participation in another clinical study with any intravenous or oral investigational product is not allowed. However, participation in a surgical clinical study including Hyperthermic Chemotherapy (HIPEC) during the surgical procedure is allowed. 26\. Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication. 27\. Patient with a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, or their excipients. 28\. Immunocompromised patient, e.g., with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids or patient who is known to be serologically positive for human immunodeficiency virus (HIV). 29\. Participant has a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian carcinoma ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

88 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Asan Medical Center
NOT_YET_RECRUITING

Seoul, Songpa-gu, 05505, South Korea
CH Valence
NOT_YET_RECRUITING

Valence, 26000, France
CHR Orléans
NOT_YET_RECRUITING

Orléans, 45100, France
CHRU Besançon - Hôpital Jean Minjoz
NOT_YET_RECRUITING

Besançon, 25000, France
CHU Grenoble-Alpes - Site Nord (La Tronche)
NOT_YET_RECRUITING

La Tronche, 38700, France
CHU Montpellier - Hôpital Saint Eloi
NOT_YET_RECRUITING

Montpellier, 34295, France
CHU Tours - Hôpital Bretonneau
NOT_YET_RECRUITING

Tours, 37044, France
CHU de Dijon - Bourgogne
NOT_YET_RECRUITING

Dijon, 21000, France
CHU de Limoges - Hôpital Dupuytren
NOT_YET_RECRUITING

Limoges, 87042, France
CHU de Poitiers - Hôpital de la Milétrie
NOT_YET_RECRUITING

Poitiers, 86021, France
CHU de Saint-Etienne - Pôle de Cancérologie
NOT_YET_RECRUITING

Saint-Priest-en-Jarez, 42055, France
CHU de Santiago de Compostela
RECRUITING

Santiago de Compostela, 15706, Spain
CHU de Strasbourg Hôpital de Hautepierre
NOT_YET_RECRUITING

Strasbourg, France
Cancer Institute Hospital Of JFCR
RECRUITING

Tokyo, Ariake, Koto, 135-8550, Japan
Centre Azuréen de Cancérologie
NOT_YET_RECRUITING

Mougins, 06250, France
Centre CARIO - HPCA
NOT_YET_RECRUITING

Plérin, 22190, France
Centre Eugène Marquis
NOT_YET_RECRUITING

Rennes, 35042, France
Centre François Baclesse
RECRUITING

Caen, 14076, France
Centre Georges François Leclerc
NOT_YET_RECRUITING

Dijon, 21079, France
Centre Henri Becquerel
NOT_YET_RECRUITING

Rouen, 76038, France
Centre Hospitalier de Cholet
NOT_YET_RECRUITING

Cholet, 49300, France
Centre Jean Perrin
NOT_YET_RECRUITING

Clermont-Ferrand, 63011, France
Centre Léon Bérard
NOT_YET_RECRUITING

Lyon, 69373, France
Centre ONCOGARD - Institut de cancérologie du Gard
NOT_YET_RECRUITING

Nîmes, 30029, France
Centre Oscar Lambret
NOT_YET_RECRUITING

Lille, 59020, France
Clinica Universidad de Navarra.
NOT_YET_RECRUITING

Pamplona, 31008, Spain
Clinique Tivoli-Ducos
NOT_YET_RECRUITING

Bordeaux, 33000, France
Clinique Victor Hugo
NOT_YET_RECRUITING

Le Mans, 72000, France
Clínica Universidad de Navarra
RECRUITING

Madrid, 28027, Spain
Complejo Hospitalario de Navarra
RECRUITING

Pamplona, 31008, Spain
Coruña University Hospital (CHUAC)
RECRUITING

A Coruña, 15006, Spain
Ehime University Hospital
NOT_YET_RECRUITING

Ehime, Toonshi, 791-0295, Japan
Firenze-Careggi
NOT_YET_RECRUITING

Florence, 50134, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING

Milan, 20133, Italy
Fundación Investigación Clínico de Valencia.
RECRUITING

Valencia, 46010, Spain
Groupe Hospitalier Diaconesses - Croix Saint-Simon
NOT_YET_RECRUITING

Paris, 75020, France
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
NOT_YET_RECRUITING

Grenoble, 38028, France
Groupe Hospitalier Pitié Salpêtrière
NOT_YET_RECRUITING

Paris, 75013, France
Gustave Roussy
NOT_YET_RECRUITING

Villejuif, 94805, France
HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
RECRUITING

Pierre-Bénite, 69495, France
HCL - Groupe Hospitalier Est
NOT_YET_RECRUITING

Bron, France
HCL - Hôpital de la Croix Rousse
NOT_YET_RECRUITING

Lyon, France
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING

El Palmar, Murcia, 30120, Spain
Hospital San Pedro de Alcantara
RECRUITING

Cáceres, 10003, Spain
Hospital Universitari Dexeus
RECRUITING

Barcelona, 08028, Spain
Hospital Universitari MutuaTerrassa
RECRUITING

Terrassa, 08221, Spain
Hospital Universitario Central de Asturias
RECRUITING

Oviedo, 33011, Spain
Hospital Universitario La Paz
NOT_YET_RECRUITING

Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING

Madrid, 28222, Spain
Hospital Universitario de Jerez
NOT_YET_RECRUITING

Jerez de la Frontera, 11407, Spain
Hospital Virgen de la Victoria
RECRUITING

Málaga, 29010, Spain
Hospital del Mar
RECRUITING

Barcelona, 08003, Spain
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING

Paris, 75015, France
Hôpital Morvan CHRU de Brest
NOT_YET_RECRUITING

Brest, 29200, France
Hôpital Nord Marseille
NOT_YET_RECRUITING

Marseille, 13915, France
Hôpital Privé Jean Mermoz
NOT_YET_RECRUITING

Lyon, 69373, France
Hôpital Privé du Confluent
NOT_YET_RECRUITING

Nantes, 44277, France
Hôpital Saint-Joseph
NOT_YET_RECRUITING

Paris, 75014, France
Hôpital Tenon
NOT_YET_RECRUITING

Paris, 75020, France
Hôpital cochin
NOT_YET_RECRUITING

Paris, 75014, France
ICANS - Institut de cancérologie Strasbourg Europe
NOT_YET_RECRUITING

Strasbourg, 67033, France
ICO - Centre René Gauducheau
NOT_YET_RECRUITING

Saint-Herblain, 44800, France
ICO Paul Papin
NOT_YET_RECRUITING

Angers, 49055, France
Institut Bergonié
NOT_YET_RECRUITING

Bordeaux, 33076, France
Institut Claudius Regaud
RECRUITING

Toulouse, 31059, France
Institut Jean Godinot
NOT_YET_RECRUITING

Reims, 51100, France
Institut Mutualiste Montsouris
NOT_YET_RECRUITING

Paris, 75014, France
Institut Paoli Calmettes
NOT_YET_RECRUITING

Marseille, 13009, France
Institut régional du cancer de Montpellier
NOT_YET_RECRUITING

Montpellier, 34090, France
Istituto Europeo di Oncologia (IEO)
RECRUITING

Milan, 20141, Italy
Jichi Medical UH
NOT_YET_RECRUITING

Shimotsuke, Tochigi, 〒329-0498 3311-1, Japan
Kurume University Hospital Clinical Research Center
RECRUITING

Kurume, Fukuoka, 〒830-0011 6, Japan
National Cancer Center
RECRUITING

Seoul, Gyeonggi-do, 10408, South Korea
National Cancer Center Hospital East
NOT_YET_RECRUITING

Kashiwanoha, Chiba, 277-8577, Japan
National Cancer Centre Singapore
NOT_YET_RECRUITING

Singapore, 168583, Singapore
National University Hospital
RECRUITING

Seoul, Jongno-gu, 03080, South Korea
National University Hospital (NUH)
NOT_YET_RECRUITING

Singapore, 119074, Singapore
Niigata Cancer Center Hospital
RECRUITING

Niigata, Niigata, 951-8566, Japan
ORACLE - Centre d'Oncologie de Gentilly
NOT_YET_RECRUITING

Nancy, 54000, France
Okayama University Hospital
NOT_YET_RECRUITING

Kita-ku, Okayama-ken, 700-8558, Japan
Ospedale San Gerardo Monza
RECRUITING

Monza, 20900, Italy
Presidio Ospedaliero di Sondrio
NOT_YET_RECRUITING

Sondrio, 23100, Italy
Sainte Catherine Institut du cancer Avignon-Provence
NOT_YET_RECRUITING

Avignon, 84918, France
Saitama Medical University International Medical Center
RECRUITING

Saitama, 350-1298, Japan
Samsung Medical Center
RECRUITING

Seoul, Gangnam-gu, 06351, South Korea
Severance Hospital
RECRUITING

Seoul, Seodaemun-gu, 03722, South Korea
University of Tsukuba Hospital
RECRUITING

Tsukuba, Ibaraki-Pref, 305-8576, Japan
Yamagata University Hospital
NOT_YET_RECRUITING

Yamagata, Yamagata, 990-9585, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.