Study of trastuzumab deruxtecan with bevacizumab versus bevacizumab alone as first-line maintenance treatment for patients with HER2-expressing ovarian cancer

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What is this study about?

This study focuses on ovarian cancer, specifically examining treatments for patients with HER2-expressing forms of the disease. The research evaluates two medications: trastuzumab deruxtecan (also known as DS-8201a) in combination with bevacizumab, compared to bevacizumab alone. These medications are given through an intravenous infusion, which means they are administered directly into a vein.

The purpose of this research is to determine if using these two medications together is more effective than using bevacizumab by itself in treating ovarian cancer. The study specifically looks at patients who have recently been diagnosed with advanced stages of the disease. Both medications are types of targeted therapy – bevacizumab works by affecting blood vessel growth in tumors, while trastuzumab deruxtecan is an antibody-drug conjugate that specifically targets cancer cells expressing the HER2 protein.

During the study, patients will receive treatment for up to 24 months. The medications will be given through regular infusions at specified intervals. Throughout the treatment period, doctors will monitor patients’ responses to the therapy and track any changes in their condition. This research is particularly focused on patients whose cancer shows specific levels of a protein called HER2 on their tumor cells.

1 Initial assessment and testing

Your tissue sample will be tested for HER2 protein expression by a central laboratory

Local testing will be performed to check your HRD (Homologous Recombination Deficiency) or BRCA gene status

2 Previous treatment confirmation

You must have completed up to 6 cycles of bevacizumab with platinum-based chemotherapy

Your doctor will confirm that you are eligible to continue with bevacizumab maintenance treatment

3 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group A: Trastuzumab deruxtecan combined with bevacizumab

Group B: Bevacizumab alone

4 Treatment administration

Both medications will be given through an intravenous infusion (directly into your vein)

Treatment will continue until your disease shows progression or other stopping criteria are met

5 Monitoring and assessment

Regular imaging scans will be performed to check your response to treatment

Your scans will be reviewed by both your doctor and independent experts

Your overall health status will be monitored throughout the study

6 Study duration

The study is planned to run from late 2025 through December 2031

Your participation duration will depend on how your body responds to the treatment

Who Can Join the Study?

  • Must be 18 years or older and able to provide informed consent for study participation
  • Must be female with confirmed diagnosis of high-grade epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (including types like serous, endometrioid, clear cell, carcinosarcoma, mucinous)
  • Must have newly diagnosed Stage III or IV cancer (FIGO staging system – a method doctors use to determine how advanced the cancer is)
  • Must have specific levels of HER2 protein expression (a protein that can be found on cancer cells) confirmed by laboratory testing
  • Must have adequate tumor tissue samples available for laboratory testing of HER2 and HRD status (HRD refers to the ability of cancer cells to repair DNA damage)
  • Must have results available from HRD or BRCA testing (tests that look for specific genetic changes in cancer cells)
  • Must have received standard treatment with bevacizumab (a cancer medication) combined with platinum-based chemotherapy and be eligible to continue bevacizumab alone
  • Must have completed up to 6 cycles of bevacizumab with platinum-based chemotherapy as initial treatment

Who Cannot Join the Study?

  • Women who are pregnant or breastfeeding
  • Patients with active brain metastases (cancer that has spread to the brain)
  • Patients with significant heart conditions, including heart failure or poorly controlled high blood pressure
  • Those with severe liver problems
  • Patients who have received certain types of cancer treatments within the last 4 weeks
  • Those with known allergies to the study medications
  • Patients with active, uncontrolled infections
  • Those who have participated in another clinical trial within the past 28 days
  • Patients with severe kidney problems
  • Those with a history of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Patients who cannot undergo regular MRI or CT scans
  • Those with certain blood disorders that could increase risks during treatment
  • Patients with poorly controlled diabetes
  • Those unable to swallow oral medications
  • Patients with active autoimmune conditions requiring systemic treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Hospital Vall d’Hebron Barcelona Spain
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Hospital Universitario da A Coruna A Coruna Galicia Spain
Virgen del Rocío University Hospital Sevilla Spain
Fakultni nemocnice Motol a Homolka Prague Czechia
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Medical University Of Vienna Vienna Austria
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Uppsala University Hospital Uppsala Sweden
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Karolinska University Hospital Solna Sweden
University Hospital Jena KöR Jena Germany
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Universitaetsklinikum Muenster AöR Munster Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Lille Lille France
Klinikum der Universitaet Muenchen AöR Munich Germany
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Medizinische Universitaet Innsbruck Innsbruck Austria
Centre Leon Berard Lyon France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
University Medical Center Hamburg-Eppendorf Hamburg Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitaetsklinikum Essen AöR Essen Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Centr Georges Francois Leclerc Dijon France
Universita Degli Studi Di Roma La Sapienza Rome Italy
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Servei De Salut De Les Illes Balears Palma Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Universitario De Navarra Pamplona Spain
Universitaetsklinikum Leipzig AöR Leipzig Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Orszagos Onkologiai Intezet Budapest Hungary
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Gyor Hungary
Hospital Universitario Donostia Donostia / San Sebastian Spain
Klinik Hietzing Vienna Austria
CHC MontLegia Liege Belgium
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Azienda USL IRCCS Di Reggio Emilia Reggio Emilia Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience Paris France
AZ Sint-Lucas & Volkskliniek Gent Belgium
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung Essen Germany

Other Sites

Site Name City Country Status
L’Hopital Prive Du Confluent Nantes France
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Medeuropa S.R.L. Bucharest Romania
Fakultni Nemocnice Bulovka Prague Czechia
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Metropolitan Hospital Athens Greece
Uowrrnabgnsximmziduol Mxdovqan Gdgt Mannheim Germany
Caasug Hnlzmaryrzk Ukjnhrkwqvbdx Dhdwqf Grgxwmf Svyacmeyqpnwbknhkfcdaqrdst Namur Belgium
Hbnvzy Dvh Hutdg Sokerwl Kkyhuinp Wectfnkjs Gfry Wiesbaden Germany
Kgqpbpni Lnuqc Gwfa Detmold Germany
Dlhklqhhmreymmqwx Sejepiiwoso Hblx guwdj Schwäbisch Hall Germany
Mpov Slmkpef Lcqu Sofia Bulgaria
Upgljkyoslydz Sbdgqkg Kzqhtwltx Nx 2 Psv W Sdpubkoafl Szczecin Poland
Gtyl Mffhodj Syuqtc Bucharest Romania
Uaiarixqmb Sztaqgrfrpk Hbnlczqp Fmc Aakzuj Trkrxfhwp It Ottcrcni Ekr Sofia Bulgaria
Axoovav Onztelyjakm Pxu Lgxncfcgppetfnbdr Cxofzfoxgg Catania Italy
Szv Lrxdnuqbodbm Hpflnlla Sauo Thessaloniki Greece
Ahfcfnr Hgeeemhu Athens Greece
Sxseouei Du Oduebjslh Mexma Sfeers Bucharest Romania
Wnlishzckikph Cgalowb Ofipkfsle Igp Mkvzg Stkcwburzntckepgug Poznan Poland
Rdg Keqovho Lmddaqdwfcttfixmienybh gyokq Ludwigsburg Germany
Mcdbzsuaxzpmpgnst Hcmlkgec Fol Argshn Tvznsgnxn Psqg Hrqozxoi Lszj Branipole Bulgaria

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
20.11.2025
Belgium Belgium
Recruiting
20.11.2025
Bulgaria Bulgaria
Recruiting
20.11.2025
Czechia Czechia
Recruiting
20.11.2025
Denmark Denmark
Recruiting
20.11.2025
France France
Recruiting
20.11.2025
Germany Germany
Recruiting
20.11.2025
Greece Greece
Recruiting
20.11.2025
Hungary Hungary
Recruiting
20.11.2025
Italy Italy
Recruiting
20.11.2025
Poland Poland
Recruiting
20.11.2025
Romania Romania
Recruiting
20.11.2025
Spain Spain
Recruiting
20.11.2025
Sweden Sweden
Recruiting
20.11.2025

Trial locations

Trastuzumab Deruxtecan (T-DXd) is a medication specifically designed to target cancer cells that express high levels of a protein called HER2. It combines an antibody that attaches to HER2 with a chemotherapy drug, delivering the treatment directly to cancer cells. This targeted approach helps to kill cancer cells while potentially reducing effects on healthy cells.

Bevacizumab is a medication that works by blocking the formation of new blood vessels that feed tumors. By preventing tumors from developing their own blood supply, this medication can help slow or stop tumor growth. It’s commonly used in various types of cancer treatment, including ovarian cancer.

Ovarian Cancer – A disease that begins in the ovaries, which are the female reproductive organs that produce eggs. It develops when abnormal cells in the ovaries begin to multiply uncontrollably and form a tumor. The cancer can spread from its original site to other parts of the body, particularly within the pelvis and abdomen. As the disease progresses, it can affect nearby organs and tissues. The condition may develop in one or both ovaries, which are located on either side of the uterus.

Trial ID:
2024-516982-35-00
Protocol code:
DS8201-772
NCT ID:
NCT06819007
Trial Phase:
Therapeutic confirmatory (Phase III)

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