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New treatment option for Ovarian Neoplasms
Official title A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
ClinicalTrials.gov ID: NCT07318558
What this study is testing
What is Sacituzumab tirumotecan?
Sacituzumab tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian neoplasms.
Also referred to as sac-TMT, MK-2870.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- The main 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...
- 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...
- Has provided tumor tissue that is not previously irradiated.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- The main 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Fort Wayne, Indiana, United States
- Covington, Louisiana, United States
- Omaha, Nebraska, 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
- CABA, Argentina
- La Rioja, Argentina
- Brisbane, Queensland, Australia
- East Melbourne, Victoria, Australia
- Vienna, State of Vienna, Austria
+ 91 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Beach, Florida, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Fort Wayne, Indiana, United States; Covington, Louisiana, United States; Omaha, Nebraska, United States and 105 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.