Study on Sac-TMT for Treating Advanced Ovarian Cancer Without HRD Mutation

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07318558

This clinical trial is exploring whether a new targeted therapy, sacituzumab tirumotecan (sac-TMT), can help people with advanced ovarian cancer live longer without their cancer worsening. The study compares sac-TMT, with or without another drug called bevacizumab, to standard care options.

Patient Parameters

Program Overview

Researchers are investigating new treatments for ovarian cancer, which often involves surgery to remove as much cancer as possible, followed by chemotherapy. After chemotherapy, patients may receive maintenance treatment to prevent cancer from growing or returning. Bevacizumab is a common maintenance therapy that targets specific cancer cells. This study is testing sacituzumab tirumotecan (sac-TMT), a targeted therapy, to see if it helps patients live longer without their cancer getting worse compared to standard care options, which may include bevacizumab or simply monitoring the cancer's progress.

Eligibility Criteria

The main inclusion criteria include but are not limited to the following:

  • Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
  • 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.
  • If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.
  • 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, or has current pneumonitis/ILD.
  • 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.
  • Has active or ongoing stomatitis of any grade.

Locations

FACILITYZIPCITYSTATE
Mount Sinai Cancer Center ( Site 0029)33140Miami BeachFlorida
Parkview Research Center at Parkview Regional Medical Center ( Site 0055)46845Fort WayneIndiana
Women's Cancer Care ( Site 0018)70433CovingtonLouisiana
Nebraska Methodist Hospital ( Site 0004)68114OmahaNebraska
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)74146TulsaOklahoma
West Cancer Center and Research Institute ( Site 0013)38138GermantownTennessee

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