Rinatabart Sesutecan plus Bevacizumab vs standard care as maintenance for recurrent platinum‑sensitive ovarian cancer after second‑line chemotherapy

3 1 1 1

What is this study about?

The study focuses on women who have a return of Platinum-Sensitive Ovarian Cancer after having received a second round of platinum‑based chemotherapy. The experimental medication, Rinatabart Sesutecan (also called Rina‑S), is given by an IV infusion and is tested together with the usual treatment that doctors normally give after chemotherapy. The comparison group receives the usual treatment alone, which in this trial includes the drug bevacizumab.

The purpose of the study is to see whether adding Rinatabart Sesutecan can keep the cancer from growing for a longer time compared with the usual treatment alone. Participants are randomly placed into one of the two groups after completing their second‑line chemotherapy, then they receive the assigned maintenance therapy for several months while doctors monitor their health through regular clinic visits and scans.

Progression‑free survival means the period during which the cancer does not get worse. Doctors use a set of rules called RECIST to measure whether tumors have grown or shrunk on imaging tests. To understand how the treatments affect overall well‑being, participants also complete a questionnaire known as the EORTC QLQ‑C30, which asks about symptoms, daily activities, and overall quality of life.

1 enrollment and consent

after joining the study, a written consent form is signed to confirm understanding of the trial procedures.

personal health information and eligibility are verified before any study activities begin.

2 baseline assessments

a series of tests are performed to record the current health status, including blood tests, imaging scans, and questionnaires about quality of life.

the results create a reference point for later comparisons during the trial.

3 assignment to treatment group

participants are randomly placed into one of two groups: the rinatabart sesutecan plus standard of care group, or the standard of care alone group that may receive bevacizumab as the comparator.

the assignment is open‑label, meaning the participant knows which treatment is being received.

4 start of maintenance therapy

the first dose of the assigned medication is given by intravenous infusion in a clinical setting.

for rinatabart sesutecan, the dose is expressed as milligram per square meter (mg/m2) and is prepared as a solution for infusion.

for bevacizumab, the dose is expressed as milligram per kilogram (mg/kg) and is also administered intravenously.

the exact amount is calculated by the study team based on body measurements and the protocol specifications.

5 repeated infusion visits

subsequent infusions are scheduled at regular intervals defined by the study protocol.

each visit includes the administration of the same medication, monitoring of vital signs, and assessment for any immediate reactions.

the infusion duration and any pre‑medication are managed by the clinical staff.

6 periodic disease evaluation

imaging scans are performed at predefined times to measure tumor size and determine progression‑free survival according to standard criteria.

the scans are reviewed by an independent central reviewer who is unaware of the treatment assignment.

7 quality‑of‑life questionnaires

participants complete the eortc qlq‑c30 questionnaire at scheduled intervals to assess overall health status and any changes over time.

8 monitoring for side effects

at each visit, health professionals ask about treatment‑emergent adverse events and record any symptoms.

laboratory tests may be repeated to detect changes that could indicate toxicity.

9 continuation or discontinuation of therapy

treatment continues until disease progression, unacceptable side effects, or the end of the study period as defined by the protocol.

if discontinuation occurs, a final assessment is performed to document the reason and collect remaining outcome data.

10 final study visit

a concluding visit includes a last set of scans, blood tests, and quality‑of‑life questionnaires.

the collected information contributes to the overall analysis of the study objectives.

Who Can Join the Study?

  • You need a confirmed diagnosis (checked under a microscope) of one of the following cancers: high‑grade serous ovarian cancer, endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • You must have platinum‑sensitive ovarian cancer (PSOC), which means your cancer got worse at least 6 months (more than 183 days) after the last dose of the first round of platinum‑based chemotherapy.
  • If you have a known BRCA mutation (either inherited or acquired) or your tumor is homologous recombination deficiency (HRD)‑positive, and you achieved a complete response (CR) or partial response (PR) after first‑line platinum chemotherapy, you must have already received a PARP inhibitor (PARPi) maintenance therapy as part of that first‑line treatment.
  • You must have finished a second‑line (2L) platinum‑based chemotherapy regimen for your recurrent cancer.
  • You need to be entered into the study (randomized) no later than 8 weeks after the last dose of the second‑line platinum chemotherapy.
  • After completing the second‑line platinum chemotherapy, you must have had a complete response (CR), no clinical evidence of disease (NED), a partial response (PR), or, if you received bevacizumab together with the chemotherapy, you may have a stable disease (SD) as judged by your doctor.

Who Cannot Join the Study?

  • Having a tumor type called clear cell, mucinous, sarcomatous, a mix of these types, or a low‑grade/borderline ovarian tumor, which are special forms of ovarian cancer that do not fit the study’s focus.
  • Having received more than two separate courses (lines) of systemic therapy (treatment that goes throughout the whole body, such as chemotherapy) before joining the trial.
  • Having cancer that got worse (progression) while on or right after the second‑line (2L) platinum‑based chemotherapy before being assigned to a study group.
  • Receiving any extra cancer treatment that travels through the whole body (intervening systemic anticancer treatment) after the last dose of the second‑line platinum chemotherapy and before starting the trial, except for the drug bevacizumab.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinik Hietzing Vienna Austria
Az Maria Middelares Gent Gent Belgium
Centre Antoine Lacassagne Nice France
L’Hopital Prive Du Confluent Nantes France
Fakultni Nemocnice Bulovka Prague Czechia
University Hospital Olomouc Olomouc Czechia
University Hospital Ostrava Ostrava Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Turku University Hospital Turku Finland
Ospedale San Raffaele S.r.l. Milan Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Klinikum Gütersloh gGmbH Guetersloh Germany
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Semmelweis University Budapest Hungary
Luokuitutjzt nyawc Fktbcecai Feldkirch Austria
Akhcarss Zimbmnqecf Doqkd Roeselare Belgium
Chfamzsuq Uajfxqtpezvfkr Szwztldgt Woluwe-Saint-Lambert Belgium
Uatajruzonam Zzpelkslva Glvv Gent Belgium
Jfdmv Ztqpqoezov Hasselt Belgium
Hjxaihe Dw Lwzalcpqa Libramont-Chevigny Belgium
Ciihww hgqmqqzndoc utucjbukhhohc dl Lvgdl Liege Belgium
Vcpuy Sint-Niklaas Belgium
Ayqjnfk Ukbzmwbotc Hrzxqqbs Aalborg Denmark
Rujqqppphtmvce Copenhagen Denmark
Ccnfos Dc Lucke Calqrg Ld Cvvjvh Eapwhw Mohsndw Rennes France
Courdn Hcpicesxapp Usmglzzzyvakv Dh Pjipzynz Poitiers France
Ilzjkirn Pfkhbacykvhnmwk Ckzzok Cylztx Marseille France
Gjadtf Hwnmvrosoxr Uynjxihyxzzpr Pcili Pbnogetyaay Eh Njgagtsnxpdc Paris France
Cvyhrm Hlbmdsntucq Izbmerizrjlue Dh Mvku Dy Mhaukj Ej Dz Pfrw Djy Snrquhp Mont-de-Marsan France
Ubbmuueipgfrbpxnlfnfr Nxaxliftpy Hz Tromsø Norway
Hrfmo Bvatja Ht Bergen Norway
Spzguypcy softhql Kndojqbsgbdy Kristiansand Norway
Fydoycys Nswrssfyf Bwvh Brno Czechia
Npjyfksxv Asev Ngxk Jxlhh auxg Novy Jicin Czechia
Fetsdori ncsxuiavr Mifub a Hllgbib Prague Czechia
Piiewattqjvel hdrpnoeblxrapxz Kuopio Finland
Pzjreltziq haylmmscpcucpyn Tampere Finland
Pjzqsduaafarwnrcyf hyxdavxcsmeclvp Oulu Finland
Aucvdjo Omqecvoiiuw Oxhtjv Mvfhjihqfr Du Tsgrvm Turin Italy
Abzmylk Ukf Tttsjtu Cdqrhv Prato Italy
Ookrgcci Vrnr Fpprm Lffrl Lecce Italy
Amlkopu Seaxk Snmjrygbf Tavdmshztwlo Dqq Svdvr Lcbch Varese Italy
Awthdto Oqbbygmbsvs Pkg Lcawieaskxpecxyjh Cbqpsucjbu Catania Italy
Fkkudwodhh Irouh Sxi Giddihg Dwj Tvaywql Monza Italy
Abxqjqh Ubd Iyfef Dr Rgsbow Ertqau Reggio Emilia Italy
Flhhnhlhhh Iiezbwjkrl Iegqkhil Nlhlmspcjig Bouza Milan Italy
Ijgnme Ijrjtmia Flsjmjnixtqzm Oqkitjtxwir Rome Italy
Afrukbfawo Mfscmor Hknkefdl Lecco Italy
Akrntrg Ufydgsqyaqhe Ljazgz Sxqfn Smhfjwilz Ne 2 Musux Twcrjbwbse Treviso Italy
Arzflbw Uwyde Slsbnqapt Lduzkw Dq Bvzlmjg Bologna Italy
Sugeecgaagno Hzdbtgvvb Gmsk Heilbronn Germany
Kgpmdyld Eqkaeqcsktmvtnqkkbzgmhcd Hysjyciwoctlkzyhg Essen Germany
Kvrngaol Kkyghj Ghap Kassel Germany
Kmaqurjx Dfa Locnvsjsbcloxukh Srnghkmev gqjnt Stuttgart Germany
Dytyqatxicownsrnn Sbdrldynrpz Hkyl gfuml Schwäbisch Hall Germany
Uvltoignzt Medvoms Cfxmvs Hwudvszwbcyydfais Hamburg Germany
Kbqygrgjzrxztnxayrnahlp Sjn Vcuqhjh mhp Limburg Germany
Cgmlpsr Obvvexjtw Zdsox Lnjmujbzwx Ijn Scx Jdjz Z Didzj Lublin Poland
Wetyhkrxjoelw Cgeokgu Oobtdjbne Iwf Mdehj Srgjcnshaobjronmse Poznan Poland
Udcivgvwhqxleg Cyjeyfe Kbjjzlqsy Ihb Pbwej Kj Gzeqnstuelt Srtsenopz Ujlkoobxyzmf Mklyvuecsf W Ksrdauowme Katowice Poland
Uarzvcfpjxoxaq Cvkbrck Kwbmxiect Gdansk Poland
Bpffpostsxnp Civqozh Oyldvszwi Ibe Miyog Srcxuzavvtcnstqzuh W Betjkftokcj Bialystok Poland
Hsdxvxpj Uoanwpaqnyhof Vaqlbd Dp Vxgaa Sevilla Spain
Hfhvlblb Upvgjsnfdecyt dt A Cxktkl A Coruna Galicia Spain
Ijvwcmxh Coupiv Dplnlahbwdzujkzyr L'hospitalet De Llobregat Spain
Uzurbxokav Cjazbshs Hmxpjybr Vbuhlf Dh Lu Arjyyvtp Murcia Spain
Hibjxbvx Uowbjxvmoqfic Aithr Vitoria Spain
Hgzjozwy Uxrttrbvfrhwq Vpqsri Dg Ls Vttexkpw Malaga Spain
Mk Axiktbbi Ctndjv Cwjptv Madrid Spain
Sjgxol Dg Svtgm Dl Lji Iotla Bfghydo Palma Spain
Uaspfneekp Oi Dwcbnhtb Debrecen Hungary
Omfwqjbs Oxjouthdpt Icqthwt Budapest Hungary
Gisaexpqkiftjvxsw Vnvmfazem Pyyi Amqjiv Emvesnbj Obnvoj Kutaud Gyor Hungary
Mhxdovs Upitdyscla Of Gzkc Graz Austria
Zuxbwmm Uournmlmbi Hblwbwjxa Dchdjpygpe oz Ccevlhnmtw Roskilde Denmark
Itjuiant Ceoad &teejpa Smvc Sefhconywxh Saint-Cloud France
Hhbxpmpso Mpdpuzjw Syczro Milan Italy
Akxpswv Ukwuq Sdmcptoum Ltsufw Tvnwend Nxuv Oastk Lucca Italy
Vnjkimpau Frwoszog Nlypoytig V Pamdo Prague Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.10.2026
Belgium Belgium
Not yet recruiting
01.10.2026
Czechia Czechia
Not yet recruiting
01.10.2026
Denmark Denmark
Not yet recruiting
01.10.2026
Finland Finland
Not yet recruiting
01.10.2026
France France
Not yet recruiting
01.10.2026
Germany Germany
Not yet recruiting
01.10.2026
Hungary Hungary
Not yet recruiting
01.10.2026
Italy Italy
Not yet recruiting
01.10.2026
Norway Norway
Not yet recruiting
01.10.2026
Poland Poland
Not yet recruiting
01.10.2026
Spain Spain
Not yet recruiting
01.10.2026

Trial locations

Rinatabart Sesutecan is an experimental medicine being studied for women whose ovarian cancer has come back after earlier treatment. It is given through an IV infusion and is designed to help keep the cancer from growing again after patients have finished a second round of platinum‑based chemotherapy. This drug is considered an orphan drug, meaning it is intended for a condition that is relatively rare.

Bevacizumab is a medication that is already used in cancer care. It works by blocking signals that tell tumors to grow new blood vessels, which can slow the growth of cancer. In this trial it is used as a comparison treatment and is also given by IV infusion.

The standard of care in this study refers to the usual chemotherapy regimen that doctors give after a second‑line platinum‑based doublet chemotherapy. It includes the typical drugs and schedules that are commonly used to maintain disease control in patients with recurrent platinum‑sensitive ovarian cancer. In the trial, some participants receive this standard treatment alone, while others receive it together with Rinatabart Sesutecan.

Platinum-sensitive ovarian cancer – A type of ovarian cancer that initially responds well to platinum‑based chemotherapy and then returns after a period of remission. After treatment, the cancer may reappear, but it tends to grow more slowly than platinum‑resistant forms. The disease often shows a measurable increase in tumor size or new lesions over time. Symptoms can develop gradually as the tumor expands within the pelvis or abdomen. Monitoring the size and spread of the cancer helps track its progression.

Trial ID:
2025-522167-15-00
Protocol code:
GCT1184-04
NCT ID:
NCT07225270
Trial Phase:
Therapeutic confirmatory (Phase III)

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