Sac-TMT as follow-up treatment after chemotherapy for newly diagnosed advanced ovarian cancer
Tests sac-TMT, with or without bevacizumab, after chemotherapy in advanced ovarian cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Aalborg, Aarhus N, Herlev, and Odense C, DenmarkSee the 4 sitesAlso in 29 other countries, 188 sites
- Trial code
- NCT07318558
- EU 2023-508047-40-00
- JRCT2031250647
- U1111-1297-5158
- Registry title
- A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 900 people, planned
- Started
- 16 Feb 2026
- Expected to end
- 25 Feb 2033
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sacituzumab tirumotecan
- Bevacizumab
- Rescue Medications
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 or older with newly diagnosed advanced ovarian, primary peritoneal or fallopian tube cancer. They must have finished first-line platinum-based chemotherapy. Their tumour must be non-HRD positive.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- FIGO 2014 Stage III or Stage IV epithelial ovarian, primary peritoneal or fallopian tube cancer. Allowed types: high-grade serous, high-grade endometrioid, clear cell, or malignant mixed Müllerian tumour with a high-grade serous part. Surgery to remove the tumour must be done.
- Earlier treatment
- Must have finished first-line platinum-based chemotherapy, with stable disease, partial response, complete response or no evidence of disease. No other earlier cancer drug treatment. No live or live-attenuated vaccine within 30 days of randomization.
- Biomarker or test result
- Tumour must not be HRD (homologous recombination deficiency) positive. Tumour tissue that was not irradiated before must be provided.
Main reasons for not taking part
- Active brain or spinal cord spread of the cancer, or carcinomatous meningitis
- History of severe eye disease
- History of or current pneumonitis or interstitial lung disease
- Inflammatory bowel disease
- HRD-positive, unknown or inconclusive tumour status
The registry criteria, word for word
Show all 23 criteriaShow less
Other criteria
- The main inclusion criteria include but are not limited to the following:
- Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present
- Has completed primary debulking surgery or interval debulking surgery
- Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol
- Has provided tumor tissue that is not previously irradiated
- Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
- Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive
- Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection; The main exclusion criteria include but are not limited to the following:
- Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has a history of severe eye disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
- Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria
- Had a live or live-attenuated vaccine within 30 days of randomization
- Has a known additional malignancy that is progressing or required active treatment within the past 3 years
- Has active infection requiring systemic therapy
- Has concurrent and active HBV and HCV infections
- Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease
- Has not recovered from major surgery or has ongoing surgical complications
- Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory
- Active or ongoing stomatitis of any grade
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
- Have your doctors told you that your cancer is advanced (stage 3 or 4)? This means it has spread beyond the ovaries to other parts of the belly or the body, even if it was later removed by surgery.
- What type of ovarian cancer do you have?
- Have you ever had lung inflammation, such as pneumonitis or interstitial lung disease?
- Has your cancer spread to the brain or the spinal cord?
Where in Denmark
Also in 29 other countries, 188 sites
- Aalborg University HospitalAalborg, DenmarkTaking people
- Region MidtjyllandAarhus N, DenmarkTaking people
- Region HovedstadenHerlev, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
About the trial
What the trial wants to find out
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
Read full original descriptionShow less
* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens
The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
The 2 groups in the trial
- Sac-TMT +/- BevacizumabTreatment being tested
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
Treatment: Sacituzumab tirumotecan, Bevacizumab, and Rescue Medications
- Standard of CareExisting treatment, for comparison
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.
Treatment: Bevacizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
- Plain-language title
- Sac-TMT as follow-up treatment after chemotherapy for newly diagnosed advanced ovarian cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07318558, who can take part
- Record updated
- 10 November 2026