Study of Sacituzumab Tirumotecan and Bevacizumab for Patients with Recurrent Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying treatments for ovarian cancer, specifically in cases where the cancer has returned after initial treatment. The study will explore the effectiveness and safety of a treatment called sacituzumab tirumotecan, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific substances in the body. In this study, sacituzumab tirumotecan will be used alone or in combination with another medication called bevacizumab, which is also a monoclonal antibody that helps prevent the growth of blood vessels that feed tumors.

The purpose of the study is to evaluate how well these treatments work in maintaining the health of patients with platinum-sensitive recurrent ovarian cancer. This means the cancer has responded to platinum-based chemotherapy in the past but has come back. The study will compare the effects of sacituzumab tirumotecan with or without bevacizumab against the standard care, which may include observation or the use of bevacizumab. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein.

The study will be conducted in two parts. The first part will focus on assessing the safety and how well patients tolerate the treatment. The second part will compare the effectiveness of the treatments in preventing the cancer from getting worse. The study will last for a period of up to 84 days, during which participants will be closely monitored for any side effects and the overall impact on their health. The goal is to find out if these treatments can help improve the quality of life and extend the time patients remain free from cancer progression.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide consent to participate.

You will undergo initial assessments to confirm eligibility, including a review of your medical history and current health status.

2 part 1: treatment initiation

In this phase, you will receive the study medication sacituzumab tirumotecan through an intravenous infusion. This means the medication will be administered directly into your vein.

You will also receive bevacizumab through an intravenous infusion. The frequency and dosage will be determined by the study team based on your specific needs.

3 part 1: monitoring and assessment

Throughout this phase, your health will be closely monitored to evaluate the safety and tolerability of the treatment. This includes regular check-ups and tests.

You will be asked to report any side effects or changes in your health to the study team.

4 part 2: treatment continuation or adjustment

Depending on your response to the initial treatment, you may continue with sacituzumab tirumotecan with or without bevacizumab, or you may be observed with or without bevacizumab.

The decision will be based on your health status and the study’s objectives.

5 part 2: ongoing monitoring

Your health will continue to be monitored regularly. This includes assessments of your overall survival and any side effects you may experience.

You will be asked to complete questionnaires about your quality of life and physical functioning.

6 completion of the study

At the end of the study, you will undergo a final assessment to evaluate your health and the effects of the treatment.

You will receive information about the study’s findings and any further steps regarding your health care.

Who Can Join the Study?

  • Must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. These are types of cancer that affect the ovaries, the tubes connecting the ovaries to the uterus, or the lining of the abdomen.
  • Must have received at least 4 cycles of platinum-based chemotherapy in the first treatment and a total of 6 cycles of carboplatin-based chemotherapy in the second treatment for ovarian cancer.
  • Must have platinum-sensitive epithelial ovarian cancer, meaning the cancer responds well to platinum-based chemotherapy.
  • Must provide a sample of tumor tissue that has not been treated with radiation before.
  • If the participant has HIV (human immunodeficiency virus), it must be well controlled with medication.
  • If the participant has hepatitis B, they must have been treated with antiviral medication for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the participant has a history of hepatitis C, the virus must not be detectable in their blood at the time of screening.
  • Must have an ECOG performance status of 0 to 1, which means the participant is fully active or has some symptoms but does not require bed rest for more than half of the day.
  • Must be female.

Who Cannot Join the Study?

  • Patients who do not have recurrent ovarian cancer cannot participate. This means the cancer has come back after treatment.
  • Only female patients can participate. Male patients are not eligible.
  • Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have difficulty giving informed consent or are at higher risk of being harmed.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Kuopio University Hospital Kuopio Finland
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Orszagos Onkologiai Intezet Budapest Hungary
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
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
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Fakultni Nemocnice Bulovka Prague Czechia
AZ Sint-Lucas & Volkskliniek Gent Belgium
Oulu University Hospital Oulu Finland
Institut Sainte Catherine Avignon France
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Fondazione Poliambulanza Brescia Italy
Spitalul Clinic Filantropia Bucharest Romania
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
University Of Debrecen Debrecen Hungary
Hospital Clinic De Barcelona Barcelona Spain
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Oncomed S.R.L. Timisoara Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Hopital Prive Des Cotes D’armor Plerin France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
Centre Francois Baclesse Caen France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Iptqtixx Ccuipg Daxcjisyslzvqgmms L'hospitalet De Llobregat Spain
Psoj Sxsfw Ljjyfpg Dq Vjkuy Chambray Les Tours France
Bnshmyvrlfm Vxqngtldx Odsougowuioh Kecskemet Hungary
Uihlkdssayeci Srzthcz Kxqgehzha Ns 2 Prt W Ssbphepfep Szczecin Poland
Fcmtyocp ngfzvthfr Mrfcw a Hnujvwv Prague Czechia
Hkzofv Hkzmkgmf Herlev Denmark
Nvvlieeb Ieibzytn Oshgkrsyd Iiy Mchjq Sacpljcihphumsmiqbsqfucnjvcn Innyndqy Bihnzfst Cracow Poland
Ajktszp Haploash Athens Greece
Ucbnlgjyyqqaki Cqrnnzm Ksycbrdsb Gdansk Poland
Sw Vlxyolnvsgwwyeu Udxlolqxkf Hvfetdzq Dublin Ireland
Uyneofuujh Ou Anlffso Edegem Belgium
Ftvyanfgh Pmmd Lj Iiugggalnjqlz Btavbbrnh Dto Hvzeeriy Ujmrukwvrwnew Lw Pwh Madrid Spain
Jdbiemsh Kgqlzg Uwqtzxjsig Linz Austria
Hjqswsds Vfld daaysdcz Barcelona Spain
Cqmyci Onvlz Lbdergy Lille France

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
26.02.2025
Belgium Belgium
Recruiting
26.02.2025
Czechia Czechia
Recruiting
26.02.2025
Denmark Denmark
Recruiting
26.02.2025
Finland Finland
Recruiting
26.02.2025
France France
Recruiting
26.02.2025
Greece Greece
Recruiting
26.02.2025
Hungary Hungary
Recruiting
26.02.2025
Ireland Ireland
Recruiting
26.02.2025
Italy Italy
Recruiting
26.02.2025
Poland Poland
Recruiting
26.02.2025
Portugal Portugal
Recruiting
26.02.2025
Romania Romania
Recruiting
26.02.2025
Spain Spain
Recruiting
26.02.2025

Trial locations

Sacituzumab Tirumotecan is a medication being studied for its potential to help treat ovarian cancer. It is designed to target and deliver a powerful anti-cancer drug directly to cancer cells, which may help to stop or slow down the growth of the cancer. In this trial, it is being used as a maintenance treatment, which means it is given to help keep the cancer from coming back after initial treatment.

Bevacizumab is a medication that works by blocking a protein called VEGF, which helps tumors grow new blood vessels. By stopping this process, bevacizumab can help to slow the growth of the cancer. In this trial, it is being used in combination with sacituzumab tirumotecan to see if it can improve the effectiveness of the treatment for ovarian cancer.

Ovarian Cancer Recurrent – Ovarian cancer recurrent refers to the return of ovarian cancer after treatment. This disease originates in the ovaries, which are part of the female reproductive system. It typically begins with abnormal cell growth in the ovarian tissue, which can form a tumor. Over time, these cancerous cells can spread to nearby tissues and organs. The progression of recurrent ovarian cancer can vary, with some cases showing slow growth and others advancing more rapidly. Symptoms may include abdominal pain, bloating, and changes in bowel habits.

Trial ID:
2023-508015-23-00
Protocol code:
MK-2870-022
Trial Phase:
Therapeutic confirmatory (Phase III)

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