NCT07225270RecruitingPhase 3
Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
This Phase 3 study will be conducted in different countries around the world with up to about 544 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer. Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also 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 weeks). 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) for each participant will be different for every participant.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 544 (estimated)
- First submitted
- 4 Nov 2025
- Start date
- 3 Apr 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Genmab
- Diseases
- Ovarian cancer
- NCT number
- NCT07225270
- EU CT number
- 2025-522167-15-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 544
- From 3 Apr 2026 to the primary completion date, Oct 2028
- 119 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
- More than 2 prior lines of systemic therapy.
- Progression while on or following 2L platinum-based regimen prior to randomization.
- Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.
- 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
- Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
- Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line \[1L\]) platinum therapy.
- Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
- Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
- Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
- Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Landeskranke nhaus Feldkirch Coordinator of this site? Confirm its status | Feldkirch Vorarlberg | Austria | Recruiting |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Klinik Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Vivalia Coordinator of this site? Confirm its status | Libramont-Chevigny | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Recruiting |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Not yet recruiting |
| 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 |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Not yet recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Not yet recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Fakultni nemocnice Bulovka 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 |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Klinikum Gütersloh gGmbH Coordinator of this site? Confirm its status | Gütersloh | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Heilbronn | Germany | Not yet recruiting |
| Klinikum Kassel GmbH Coordinator of this site? Confirm its status | Kassel | Germany | Not yet recruiting |
| Krankenhausgesellschaft St. Vincenz mbH Coordinator of this site? Confirm its status | Limburg | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| DIAK Klinikum Landkreis Schwaebisch Hall gGmbH Coordinator of this site? Confirm its status | Schwaebisch Hall | Germany | Not yet recruiting |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR Coordinator of this site? Confirm its status | Stuttgart | Germany | Not yet recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Not yet recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Not yet recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | 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 |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Not yet recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria | Spain | Not yet recruiting |
| Pohjois-Savon hyvinvointialue Coordinator of this site? Confirm its status | Kuopio | Finland | Not yet recruiting |
| Pohjois-Pohjanmaan hyvinvointialue Coordinator of this site? Confirm its status | Oulu | Finland | Not yet recruiting |
| Pirkanmaan hyvinvointialue Coordinator of this site? Confirm its status | Tampere | Finland | Not yet recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Not yet recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Coordinator of this site? Confirm its status | Mont-De-Marsan Cedex | France | Recruiting |
| L'Hopital Prive Du Confluent Coordinator of this site? Confirm its status | Nantes Cedex 2 | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Recruiting |
| Fondation Hôpital Saint-Joseph Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Recruiting |
| Institut de cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy_ Cedex | France | 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 |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | 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 |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | 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 |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Ospedale Vito Fazzi Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Not yet recruiting |
| Alessandro Manzoni Hospital Coordinator of this site? Confirm its status | Lecco | Italy | Not yet recruiting |
| Azienda Unita' Sanitaria Locale Toscana Nord Ovest Coordinator of this site? Confirm its status | Lucca | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia 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 |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | 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 |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Not yet recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana Coordinator of this site? Confirm its status | Treviso | Italy | Not yet recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Not yet recruiting |
| Hyogo Cancer Center Coordinator of this site? Confirm its status | Akashi | Japan | Recruiting |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka | Japan | Recruiting |
| The Jikei University Kashiwa Hospital Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| St Marianna University School of Medicine Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Recruiting |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nagaizumi-chō | Japan | Recruiting |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Recruiting |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| National Hospital Organization Hokkaido Cancer Center Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Mie University Graduate School of Medicine Coordinator of this site? Confirm its status | Tsu | Japan | Recruiting |
| Kanagawa Prefectural Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Not yet recruiting |
| Sorlandet Sykehus HF Coordinator of this site? Confirm its status | Kristiansand S | Norway | Not yet recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | 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 |
| Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Instytut Centrum Zdrowia Matki Polki Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu 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 |
| Miami Valley Hospital South Coordinator of this site? Confirm its status | Centerville | United States | Recruiting |
| Novant Health Presbyterian Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Missouri Cancer Associates Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Zangmeister Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Alliance Cancer Specialists - Abington Hematology Oncology Associates - Horsham Coordinator of this site? Confirm its status | Horsham | United States | Recruiting |
| Mt. Sinai Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Methodist Estabrook Cancer Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Sarasota Memorial Health Care System Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Greater Baltimore Medical Center Coordinator of this site? Confirm its status | Towson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.