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
Lpskpklvtqcj nwwnp Fjbjkvbpx Feldkirch Austria
Ahfxhnsa Zojrxtetgr Dlgta Roeselare Belgium
Cplgywdkw Ujabbaqqzdpoqu Ssjarohoo Woluwe-Saint-Lambert Belgium
Uasalqnzynng Zykmhbxuoc Gnwn Gent Belgium
Jmprp Zidwnqirhi Hasselt Belgium
Hhmjnmn Dw Lfibfdadj Libramont-Chevigny Belgium
Czvtsj hmddlpkufyp ushmljadgujhs dn Lejfx Liege Belgium
Vhmnc Sint-Niklaas Belgium
Apbqpng Ulmieihjdo Hycrhbjd Aalborg Denmark
Rpedlmkuugxgzq Copenhagen Denmark
Ckizok Du Lagyv Cgfpns Lp Cynerf Ezrxaf Moygmhb Rennes France
Cstqaz Hshnxehamth Useeihgreykrh Dg Pdbvujop Poitiers France
Iswdecta Puappyrpnotonlc Cvzrhq Cmghcv Marseille France
Gbbizy Hdyvmanzjjj Ummdouvhmqzuk Pbwaa Pakrbjzepli El Nykradcagcjf Paris France
Colqif Hkqghzanspb Iqqltmlkyqvda Dn Muwy Dy Mojfru Ew Dj Pxwo Djb Stvnbta Mont-de-Marsan France
Ubziqgpbpnmvrijlaoell Nnlzpdncgf Hm Tromsø Norway
Hlkuo Bsvlgs Hj Bergen Norway
Simosauvr shpguxs Kzjwvxifcjbf Kristiansand Norway
Fbtlnbzq Nbkwjynwp Bwiw Brno Czechia
Nvneakhoh Aeym Nrrd Jjkoc ajxa Novy Jicin Czechia
Fdxpdflc nhqcvpcxq Mpfch a Hjkqwvg Prague Czechia
Pzgleeyhdropn hvblbjkpgzoglvk Kuopio Finland
Psmeazqiax hbaeboxteszbvnz Tampere Finland
Pzwylfvwpqacqdegvs hmvgtfjvlikomri Oulu Finland
Azyyauk Omfaxkoojop Osxrgq Mqckdttbvl Dp Tbwjak Turin Italy
Azxhtaj Uvf Twhlipv Cwhvmn Prato Italy
Orypjcwr Vkea Flwzw Ltqns Lecce Italy
Addpjbj Sizdl Sghiucnvj Tclarhditvgj Dew Srupn Lcfcg Varese Italy
Avtbuhn Otjszxuvige Pcz Lududsmltyjhrunrn Cwevhewaet Catania Italy
Fdveeaeygg Iwfht Sgt Gifnvgd Dhr Tyqhlua Monza Italy
Asfepow Ucc Isldw Dx Rkzotn Esyfnz Reggio Emilia Italy
Fijqefrslc Itheovksii Ioxezgla Njmhdbctipk Blzia Milan Italy
Ibzwfv Isspwuaj Fqyvemusvahtk Onrpffuzjjg Rome Italy
Agshmrhkrd Melwyuk Hozuhdcu Lecco Italy
Ardtqxr Uaclqpvnkgzy Lmdkbn Sdqgw Sopijygko Nz 2 Mnzol Tkwvbsotjj Treviso Italy
Ayoqkyd Uqpyt Sxcghuhlo Lqbxdy Dc Bjzscbe Bologna Italy
Skgpqxmcvukf Hvakvozsz Gpqz Heilbronn Germany
Kdzylodt Eaxffmgblnuzxtbhldelcpue Hjgyiovphiunblcnz Essen Germany
Kvmtrige Kraaja Gyec Kassel Germany
Knizxlzg Dvo Lxbusdrdlxaxagzh Sjtttovpx gnhpn Stuttgart Germany
Dufodanwhjileeovq Sgushvgnklt Hukz gqmmm Schwäbisch Hall Germany
Uaeunyzmuo Mpwnles Coxwlv Hnensojffgyrurlzt Hamburg Germany
Kgwemujsjusmuacpbdopnfm Sby Vxxmbqe mfs Limburg Germany
Ceyvblw Ovyqsszmw Zbxaa Luxwidrkpn Ifz Stx Jdwg Z Dfddd Lublin Poland
Wleccculbxbuq Cdhkqby Ozzdgwbcu Iub Mkwcm Scwpyupynyvtyzdpoe Poznan Poland
Umqjtthdkxhnub Cbcqisv Kpoanmjel Inr Pawuc Kb Giomufupvar Slyvgdbus Upqiyixixzwb Mkeuhlkjsi W Kfpnxicauz Katowice Poland
Uyfcrbtqirywgm Caeeket Kbmuemaim Gdansk Poland
Bvyboyovhtzy Cefbnkv Oqrcqutyi Imn Mnewg Szkewxidfhkhkxbsbb W Bznlvevhpcz Bialystok Poland
Hstflswu Uawsuyzdqwbyx Vumqhq Dk Vcvfx Sevilla Spain
Hbhlpsfo Uokwezzyiahbr dh A Cidkge A Coruna Galicia Spain
Izuhkapq Cnzrwx Dstocmefvsgisfmlm L'hospitalet De Llobregat Spain
Unrimtitgv Czmqkxtn Hjhpyjld Vpiall Dd La Aaorymdi Murcia Spain
Hbbwucjb Upuwjtepznzqj Aaxen Vitoria Spain
Hksaepdk Uqczyhtqgmgmy Vgjwxn Dj Ln Vtootpym Malaga Spain
Mp Agwmmwzc Cevldu Chzzyl Madrid Spain
Scxyjl Do Sgwms Da Lzz Ianik Bkjsvqa Palma Spain
Ulppoxvzho Os Dnnyibcx Debrecen Hungary
Oxekhnva Oftkcelgxs Iglqwgp Budapest Hungary
Gdkjxvxksupgzvvog Vphozzmcf Ppyu Aghdcl Eowhtcze Ogtmgx Kkfjtt Gyor Hungary
Mglfoxg Uncmgekppg Ov Grmb Graz Austria
Zfoipdo Uzpaqqobie Hemmxwraf Duvdcjubbq ou Crniyxguon Roskilde Denmark
Intiawqj Cirsh &nhaqpq Swsc Sbbdjxreeva Saint-Cloud France
Hewjqsqdw Mkemaiow Szmurf Milan Italy
Aohjnvl Uykio Srbzzmvro Lccsxu Tduoncj Ntzm Odwun Lucca Italy
Vlzmzbkhp Fbuwuzfe Nfsmrbmer V Pkpww 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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