No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for people with advanced ovarian cancer who have already received certain treatments. Participants will receive a treatment called sacituzumab tirumotecan to see if it helps keep the cancer from worsening.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced ovarian cancer.
I have completed surgery to remove cancer.
I have finished my first round of chemotherapy.
I have provided tumor tissue that has not been treated with radiation.
I have well-controlled HIV if I am HIV positive.
I have undetectable hepatitis B if I am HBsAg-positive.
I have undetectable hepatitis C if I have HCV history.
You may not be able to join if
I have non-epithelial cancers or low-grade tumors.
I have known active brain cancer or meningitis from cancer.
I have had severe eye disease.
I have ongoing inflammation in my bowel that needs medicine.
I have uncontrolled heart or blood vessel disease.
I have a history of lung problems that needed steroids.
I have received any cancer treatment besides my first chemotherapy.
I currently have an active infection that needs treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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:
* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is …
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:
* 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.
Trial Locations
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Status
Eligibility 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 endometrioi…
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.
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