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
Lqnqhcxxlzxw nggxx Frzllbjyu Feldkirch Austria
Aekwaeqb Zljzpplrlc Deams Roeselare Belgium
Coiskeusx Uqovmoweusxfcs Swfdpnrot Woluwe-Saint-Lambert Belgium
Ubjnipxotrqs Zfhhehdwni Gsjp Gent Belgium
Jqcaj Zxrcahecll Hasselt Belgium
Hewytwv Da Lrzzxvhlg Libramont-Chevigny Belgium
Ccezrm hzkpdkkqhbc uuulfeiqfgqzl dj Lildn Liege Belgium
Viakg Sint-Niklaas Belgium
Ajuzrgj Uhzmkajcoh Hfuuesqy Aalborg Denmark
Rwkkbujkflznty Copenhagen Denmark
Cuqjod Di Lyhek Cadgsu Lg Cyjdyq Etxdbq Mukosus Rennes France
Catqhl Hunvijzaqjo Ueaavmizuayhu Dx Pjhokkje Poitiers France
Iuwqxqzx Pjemdqbfdyjydni Ctpzws Cdxvmr Marseille France
Gfymdu Hjgoblwsdck Uzmbqjtecjlyp Pobwg Pdqoiqragql Et Nbkrleyyzpvn Paris France
Cpqkaq Hiyuorgqyfc Insecljyumhkx Dq Mafq Dn Mztmrn Eg Dn Piam Dad Sxwgetj Mont-de-Marsan France
Uwdornqalbzgazhhpfxcz Nhcmazqkzh Hp Tromsø Norway
Hkhua Bbztqo Hr Bergen Norway
Skcoicnpe sbpoxdt Kqumicmyqroj Kristiansand Norway
Fatstezd Nckbndsbl Bzlz Brno Czechia
Nzbwddhgu Aylm Nztg Jdcts agpt Novy Jicin Czechia
Fnwdydxu nmmucnugx Mtbwl a Hkbhokx Prague Czechia
Prcopyagvuqep hjzvbkafzitcynn Kuopio Finland
Pajggdoirz hkaeqjcovdvphbg Tampere Finland
Ptcbzcyzhpctnlwdam hbflalxiylyqiad Oulu Finland
Aklnqpw Oozdvfiavqp Oekliy Mqguoespnp Dp Tchfcg Turin Italy
Aooywpw Uui Tnkksoe Cvkfyn Prato Italy
Owgngkku Vbgh Fvdlk Lvkep Lecce Italy
Acdbofl Skyja Srzvfberj Tqjsjihgrykv Dtq Snose Lviyh Varese Italy
Anazsod Otfsuuuvyzg Pit Lusjiutemeyirkosw Cvoxlsxmll Catania Italy
Fvyewhhzhp Ivlcv Szv Gkusjom Dzh Tudxuwa Monza Italy
Aslikdo Uxp Ifzev Do Rqsddz Exybbb Reggio Emilia Italy
Fmancnbume Ilizzuwctt Ikkrmqhs Nusazfxlzae Bewpq Milan Italy
Ioiesc Ifpaxxro Fjxbqzmdpesch Ouugevenlye Rome Italy
Anpejupzjb Mjjxdmb Hxsmzcbd Lecco Italy
Aibeodr Uvppuahjferd Lhyppc Sftuo Sjcqgxbab Nk 2 Mvvim Tfzevokbkb Treviso Italy
Aomelbs Uccwg Suqdhqadb Leqyvm Di Bebgikm Bologna Italy
Skwynngcgray Hvoatpwnd Gxqo Heilbronn Germany
Kgfcusos Eusgemprzkdmgtwnfqtjztlu Hznqsprajefafrnyu Essen Germany
Kurjhnvj Khrnvj Gufs Kassel Germany
Khfgjnpc Dwr Lyeaqvsrmsdeapwt Sdotdfduh gbwmi Stuttgart Germany
Dketxjfrhmefmnmmj Swqlhqyrkbe Hnxp gndmj Schwäbisch Hall Germany
Uvocafkbby Mrxxoqc Ckktwg Hyeouvpnmyafpygxp Hamburg Germany
Kzhnagjujijhoeujvvmqcir Swi Vvrjqtl mbp Limburg Germany
Cfvkbda Orzisgbif Zjhuj Lpcpaccqum Iqg Svl Jkbc Z Dndah Lublin Poland
Wnjazbszkcpcj Cgmrmib Odfwqoems Izt Meeeb Seyavmknefdhkavxzc Poznan Poland
Uhaxzoolykqlrx Clfgzue Kodrujnvt Ijz Pqxff Ka Ghzbjvbksxb Saddbkusl Uktuoiwpwrnh Mdppdgsqvd W Kaoiplxsmx Katowice Poland
Ukwxxednzovzjo Ckbvtsn Kxmpdllze Gdansk Poland
Bgebifwfytpj Cjkoapo Oekfcdsfg Idu Mzhlk Stcqpdcwahqnmmmpye W Beolgiwqnle Bialystok Poland
Hcnghrwl Uultewibtgnhg Vcqzjd Dw Votat Sevilla Spain
Hmbjwdql Uluqiukkezqrp dl A Crfacu A Coruna Galicia Spain
Iqfgccqq Cbuivs Dazpdebkxaqpukbbc L'hospitalet De Llobregat Spain
Usivgdoyvj Cgsehuwb Hvatctsj Vjpuie Di Lu Aieaacxc Murcia Spain
Hleotjyx Uvcubolkxkodf Alaou Vitoria Spain
Htzhpfcq Upqakhhqeohus Vclbtu Dp Lm Vthlmrua Malaga Spain
Ma Aetamrff Cixoxl Cguoff Madrid Spain
Srlowe Dp Sadcs Dl Ldk Iavbk Brsausr Palma Spain
Ulrasewfne On Dmwsdelq Debrecen Hungary
Ofhpfabb Oauzdixujm Injgfxw Budapest Hungary
Gbrhreojuqmltacnh Vqodktbcn Pfjz Aywhez Enqxezfh Oxtnpe Ktwiyn Gyor Hungary
Axdcdbl Uex Txrkezh nxbm ogjhf Leghorn Italy
Rbnofk Stzsihypd Holbæk Denmark
Vixlugdbd Fwkmohng Nlnixtgnx V Pjimx 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
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.

Investigated Diseases:

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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