RecruitingPhase 3NCT05009082

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

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


Sponsor

AGO Study Group

Enrollment

970 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding bevacizumab (a drug that blocks blood vessel growth in tumors) to niraparib (a PARP inhibitor) is better than niraparib alone as maintenance therapy for women with advanced ovarian, peritoneal, or fallopian tube cancer after they have responded to initial chemotherapy. **You may be eligible if...** - You are a woman 18 or older with advanced (Stage III or IV) high-grade ovarian, peritoneal, or fallopian tube cancer - You have had debulking surgery (either upfront or planned after chemotherapy) - You are in or near remission after initial chemotherapy - Tumor tissue samples are available for testing **You may NOT be eligible if...** - You have a low-grade, mucinous, or clear cell ovarian cancer - You have Stage IIIA cancer without lymph node involvement - You are not able to tolerate maintenance therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCarboplatin

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

DRUGPaclitaxel

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

DRUGBevacizumab

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

DRUGNiraparib

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


Locations(65)

Klinikum St. Marien Amberg

Amberg, Germany

Klinikum Augsburg

Augsburg, Germany

Hochtaunus-Kliniken

Bad Homburg, Germany

Helios Klinikum Berlin-Buch

Berlin, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany

Städt. Klinikum Brandenburg

Brandenburg an der Havel, Germany

Klinikum Bremen Mitte

Bremen, Germany

Klinikum Chemnitz

Chemnitz, Germany

St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, Germany

Klinikum Dortmund

Dortmund, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Florence-Nightingale-Krankenhaus Düsseldorf

Düsseldorf, Germany

Universitätsfrauenklinik Düsseldorf

Düsseldorf, Germany

KEM Essen | Evang. Kliniken Essen-Mitte gGmbH

Essen, Germany

Universitätsklinikum Essen

Essen, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Klinikum Frankfurt Höchst

Frankfurt am Main, Germany

Universitätsklinikum Gießen

Giessen, Germany

Klinikum Gütersloh

Gütersloh, Germany

Universitätsklinikum Halle

Halle, Germany

Albertinen Krankenhaus

Hamburg, Germany

Mammazentrum HH am Krankenhaus Jerusalem

Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Gynäkologisch-Onkologische Praxis am Pelikanplatz

Hanover, Germany

Universitätsklnikum Heidelberg

Heidelberg, Germany

Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Gyn.-onkolog. Gemeinschaftspraxis Hildesheim

Hildesheim, Germany

Universtitätsklinikum Jena

Jena, Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Germany

Klinikum Kassel

Kassel, Germany

Klinikverbund Kempten-Oberallgäu gGmbH

Kempten, Germany

Klinikum Konstanz

Konstanz, Germany

Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld

Krefeld, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

St. Vincenz Krankenhaus

Limburg, Germany

Klinikum Ludwigsburg

Ludwigsburg, Germany

UKSH Campus Lübeck

Lübeck, Germany

Universitätsmedizin Mainz

Mainz, Germany

Universitätsklinikum Mannheim GmbH

Mannheim, Germany

UKGM Gießen/Marburg Standort Marburg

Marburg, Germany

Mühlenkreiskliniken, Johannes Wesling Klinikum Minden

Minden, Germany

LMU Klinikum München-Großhadern

München, Germany

Rotkreuzklinikum München

München, Germany

Universitätsklinikum Münster

Münster, Germany

Klinikum Neumarkt

Neumarkt, Germany

MVZ Nordhausen

Nordhausen, Germany

Ortenau Klinikum Offenburg-Kehl

Offenburg, Germany

St. Vincenz Krankenhaus GmbH

Paderborn, Germany

Studienzentrum Onkologie Ravensburg

Ravensburg, Germany

Krankenhaus Barmherzige Brüder

Regensburg, Germany

Klinikum am Steinenberg

Reutlingen, Germany

RoMed Klinikum Rosenheim

Rosenheim, Germany

Klinikum Südstadt Rostock

Rostock, Germany

Thüringen-Kliniken "Georgius Agricola"

Saalfeld, Germany

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Germany

g.SUND

Stralsund, Germany

Klinikum Stuttgart

Stuttgart, Germany

Klinikum Traunstein

Traunstein, Germany

Klinikum Mutterhaus

Trier, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinik Ulm

Ulm, Germany

St. Josefs-Hospital

Wiesbaden, Germany

Klinikum Worms

Worms, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05009082


Related Trials