Sac-TMT maintenance for people with non-HRD advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial enrolls people with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who have completed primary or interval debulking surgery and first‑line platinum‑based chemotherapy with at least stable disease. Eligible participants provide tumor tissue and are assigned to receive sac‑TMT maintenance with or without bevacizumab or to standard care (bevacizumab maintenance or observation) per protocol. The main outcome is how long participants live without their cancer getting worse (progression‑free survival), along with safety monitoring. The trial is sponsored by Merck and is conducted at multiple U.S. cancer centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama - Birmingham ( Site 0058)
  Birmingham, Alabama, United States Recruiting
• UCSD Moores Cancer Center ( Site 0038)
  La Jolla, California, United States Recruiting
• John Muir Health Cancer Center ( Site 0069)
  Walnut Creek, California, United States Recruiting
• Anschutz Cancer Pavilion ( Site 0049)
  Aurora, Colorado, United States Recruiting
• University of Colorado Health - Highlands Ranch Hospital ( Site 0094)
  Highlands Ranch, Colorado, United States Recruiting
• Mount Sinai Cancer Center ( Site 0029)
  Miami Beach, Florida, United States Recruiting

+127 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.