A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
18 Years and older, Male and Female
2870-021 (primary)
NCI-2026-02084
2023
2023-508047-40-00
ENGOT-ov85
GOG-3102
jRCT2031250647
MK-2870-021
U1111-1297-5158
Summary
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
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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