sac-TMT +/- bevacizumab vs SoC after Chemo in Ovarian Cancer
Research type
Research Study
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 (TroFuse 022/ENGOT ov84/GOG-3103)
IRAS ID
1011069
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are seeking new treatments for recurrent ovarian cancer (OC), which means the cancer has returned after initial treatment. Recurrent OC can affect the ovaries, the lining of the abdomen, or the fallopian tubes connecting the ovaries to the womb.
People with recurrent OC often require a second treatment. After this, the standard care is either:
• Maintenance treatment to prevent cancer growth or return
• Observation to monitor if the cancer worsensSacituzumab tirumotecan (sac-TMT), the study medicine, is a targeted therapy; a treatment that works to control how specific types of cancer grow and spread. Bevacizumab is a targeted therapy used for standard maintenance treatment.
Researchers want to learn about the safety of sac-TMT with bevacizumab and if people tolerate it . Also If people who take sac-TMT with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care.
About 770 people (assigned female at birth) with OC will be in this study. They will be at least 18 years old and:
• Had OC come back after a first treatment with a type of chemotherapy called platinum-based. Chemotherapy is medicine that works to destroy cancer cells or stop them from growing.
• Had a second treatment with platinum-based chemotherapy plus another chemotherapy and had OC got smaller, went away, or stayed the same size.
• Did not receive treatment with certain other targeted therapiesThis study will have 2 parts, with the UK will only be participating in Part 2
Part 2: Researchers will assign about 750 people by equal chance to 1 of 2 treatment groups:
Group 1: People will receive sac-TMT with or without bevacizumab
Group 2: People will receive standard of care, which is observation with or without bevacizumabA person may be in the study for about 4 years.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0591
Date of REC Opinion
6 Oct 2025
REC opinion
Further Information Favourable Opinion