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NCT07564141RecruitingPhase 3

Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab. Participants will receive either: * Rina-S monotherapy (by itself), * Rina-S plus bevacizumab, * investigator's choice chemotherapy (by itself) (standard of care), or * investigator's choice chemotherapy plus bevacizumab (standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
688 (estimated)
First submitted
27 Apr 2026
Start date
28 Aug 2026
Primary completion date
31 Dec 2029
Lead sponsor
Genmab
NCT number
NCT07564141
EU CT number
2025-524202-15-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 688
  • From 28 Aug 2026 to the primary completion date, 31 Dec 2029
  • 88 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
  • Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
  • Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).
    • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Other

  • Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.

Who the study is looking for

  • Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
  • Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \>183 days) after their last dose administration of platinum-based therapy.
  • Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
  • Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
  • All participants must provide a tumor specimen.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (88)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaNot yet recruiting
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaNot yet recruiting
Fakultni nemocnice Bulovka
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PragueCzechiaNot yet recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaNot yet recruiting
Fakultni Nemocnice Motol a Homolka
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PragueCzechiaNot yet recruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyNot yet recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyNot yet recruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyNot yet recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyNot yet recruiting
Universitaet Des Saarlandes
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HomburgGermanyNot yet recruiting
Otto Von Guericke Universitaet Magdeburg
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MagdeburgGermanyNot yet recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainNot yet recruiting
Institut Catala d'Oncologia
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BadalonaSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Hospital Universitario de Jaén
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JaénSpainNot yet recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainNot yet recruiting
Clinica Universidad de Navarra
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MadridSpainNot yet recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainNot yet recruiting
University Hospital Son Espases
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PalmaSpainNot yet recruiting
Clínica Universidad de navarra
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PamplonaSpainNot yet recruiting
Parc Tauli Hospital Universitari
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SabadellSpainNot yet recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainNot yet recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainNot yet recruiting
Pohjois-Savon hyvinvointialue
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KuopioFinlandRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Turku University Hospital
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TurkuFinlandRecruiting
Clinique Tivoli-Ducos
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BordeauxFranceWithdrawn
Centre Francois Baclesse
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Caen Cedex 5FranceWithdrawn
Pole Sante Leonard De Vinci
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Chambray-lès-ToursFranceWithdrawn
Centre Jean Perrin
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Clermont Ferrand Cedex1FranceWithdrawn
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceWithdrawn
Assistance Publique Hopitaux de Paris
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ParisFranceWithdrawn
Hospices Civils de Lyon
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Pierre-BéniteFranceWithdrawn
CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'Oncologie
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PlerinFranceWithdrawn
Institut Godinot
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ReimsFranceWithdrawn
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceWithdrawn
General Hospital of Athens - Alexandra
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AthensGreeceNot yet recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceNot yet recruiting
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
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FilotheiGreeceNot yet recruiting
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
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MaroussiGreeceNot yet recruiting
General University Hospital Of Patras
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PatrasGreeceNot yet recruiting
Semmelweis University
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Budapest VIIIHungaryNot yet recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryNot yet recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryNot yet recruiting
Bon Secours Hospital Cork
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CorkIrelandNot yet recruiting
Cork University Hospital
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CorkIrelandNot yet recruiting
Mater Misericordiae University Hospital
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Dublin 7IrelandNot yet recruiting
St James's Hospital
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Dublin 8IrelandNot yet recruiting
University Hospital Waterford
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WaterfordIrelandNot yet recruiting
Azienda Unita' Sanitaria Locale Toscana Sud Est
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ArezzoItalyNot yet recruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyNot yet recruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyNot yet recruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
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CataniaItalyNot yet recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyNot yet recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyNot yet recruiting
Humanitas Mirasole S.p.A.
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MilanItalyNot yet recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyNot yet recruiting
Azienda USL Toscana Centro
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PratoItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyNot yet recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyNot yet recruiting
Niigata Cancer Center Hospital
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Chuo Ku NiigataJapanRecruiting
The Cancer Institute Hospital of JFCR
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TokyoJapanRecruiting
Yamagata University Hospital
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YamagataJapanRecruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
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KaunasLithuaniaRecruiting
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
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VilniusLithuaniaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsNot yet recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsNot yet recruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Szpitale Pomorskie Sp z o o
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GdyniaPolandNot yet recruiting
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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PoznanPolandNot yet recruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
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SiedlcePolandNot yet recruiting
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandNot yet recruiting
Alliance Cancer Specialists, PC
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BensalemUnited StatesRecruiting
Danbury Hospital
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DanburyUnited StatesRecruiting
City of Hope
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DuarteUnited StatesRecruiting
West Virginia University
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MorgantownUnited StatesRecruiting
Compass Oncology - West Cancer Center (Northwest Cancer Specialists, P.C.)
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TigardUnited StatesRecruiting
ProHealth Care Inc
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WaukeshaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.