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
- Diseases
- Ovarian cancer
- 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
Sites (88)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Not yet recruiting |
| Nemocnice AGEL Nový Jičín a.s. Coordinator of this site? Confirm its status | Nový Jičín | Czechia | Not yet recruiting |
| Fakultni nemocnice Bulovka Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Not yet recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Not yet recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Not yet recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Not yet recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Not yet recruiting |
| Otto Von Guericke Universitaet Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Not yet recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Not yet recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Not yet recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Not yet recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Not yet recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Not yet recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Not yet recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Pohjois-Savon hyvinvointialue Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Withdrawn |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Withdrawn |
| Pole Sante Leonard De Vinci Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Withdrawn |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont Ferrand Cedex1 | France | Withdrawn |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Withdrawn |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Withdrawn |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Withdrawn |
| CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'Oncologie Coordinator of this site? Confirm its status | Plerin | France | Withdrawn |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Withdrawn |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Withdrawn |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Not yet recruiting |
| Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A. Coordinator of this site? Confirm its status | Filothei | Greece | Not yet recruiting |
| Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Not yet recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Not yet recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Not yet recruiting |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Not yet recruiting |
| Bon Secours Hospital Cork Coordinator of this site? Confirm its status | Cork | Ireland | Not yet recruiting |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Not yet recruiting |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Not yet recruiting |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Not yet recruiting |
| University Hospital Waterford Coordinator of this site? Confirm its status | Waterford | Ireland | Not yet recruiting |
| Azienda Unita' Sanitaria Locale Toscana Sud Est Coordinator of this site? Confirm its status | Arezzo | Italy | Not yet recruiting |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Not yet recruiting |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Azienda Ospedaliera per l Emergenza Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Not yet recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Azienda USL Toscana Centro Coordinator of this site? Confirm its status | Prato | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Not yet recruiting |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku Niigata | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Recruiting |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Not yet recruiting |
| Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Not yet recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Bensalem | United States | Recruiting |
| Danbury Hospital Coordinator of this site? Confirm its status | Danbury | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Compass Oncology - West Cancer Center (Northwest Cancer Specialists, P.C.) Coordinator of this site? Confirm its status | Tigard | United States | Recruiting |
| ProHealth Care Inc Coordinator of this site? Confirm its status | Waukesha | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.