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A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

NCT07318558

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Ovarian Neoplasms, Ovarian Cancer

Interventions: Sacituzumab tirumotecan, Bevacizumab, Rescue Medications

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.
Locations (135)
  • Miami Beach, Florida, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Arlington Heights, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Covington, Louisiana, United States
  • Scarborough, Maine, United States
  • Omaha, Nebraska, United States
  • Omaha, Nebraska, United States
  • Cincinnati, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Providence, Rhode Island, United States
  • Germantown, Tennessee, United States
  • Knoxville, Tennessee, United States
  • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
  • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
  • Mar del Plata, Buenos Aires, Argentina
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Rosario, Santa Fe Province, Argentina
  • Rosario, Santa Fe Province, Argentina
  • CABA, Argentina
  • La Rioja, Argentina
  • Brisbane, Queensland, Australia
  • East Melbourne, Victoria, Australia
  • Vienna, State of Vienna, Austria
  • Innsbruck, Tyrol, Austria
  • Charleroi, Hainaut, Belgium
  • Ghent, Oost-Vlaanderen, Belgium
  • Leuven, Vlaams-Brabant, Belgium
  • Natal, Rio Grande do Norte, Brazil
  • + 105 more on CT.gov