About this trial
This trial is explored in two parts: Part 1 will review the safety profile, and patients will receive Sacituzumab Tirumotecan and Bevacizumab.
In Part 2 patients will either join Group 1 or Group 2. In Group 1, patients will receive Sacituzumab Tirumotecan and Bevacizumab and Group 2 Patients will receive Standard of Care treatment (and bevacizumab at the investigator’s discretion).
Ovarian cancer is a type of cancer that starts in the tissues inside ovaries, fallopian tubes or peritoneum.
Recurrent means the cancer came back after surgery
Platinum-sensitive describes ovarian cancer that has responded well to platinum-based chemotherapy drugs
Sacituzumab tirumotecan (also known as sac-TMT) and Bevacizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
Patient Profile
Women aged 18 or older with advanced or recurrent ovarian cancer — meaning the disease has either spread beyond what can be removed by surgery or has come back after earlier treatment.
Patients must have received 4 or more cycles of platinum-based chemotherapy in first-line and a total of 6 cycles of carboplatin based doublet chemotherapy in second-line setting.
They must not have had certain prior treatments (especially certain immunotherapies or targeted drug-conjugates) as defined by the study protocol
Where’s this trial being run?
St James’s Hospital and St Vincents University Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | ENGOT OV-84 Trofuse-022 |
|---|---|
| Number: | 24-41 |
| Full Title: | A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer |
| Principal Investigator: | Prof Karen Cadoo |
|---|---|
| Type: | Collaborative |
| Sponsor: | MSD |
| Recruitment Started: |
Global: Apr 25 Ireland: Apr 26 |
| Global Recruitment Target: | 750 |
|---|---|
| Ireland Recruitment Target: |