Clinical trial 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?
An investigational intravenous medicine being studied as a maintenance treatment for ovarian cancer.
Also referred to as sac-TMT, MK-2870, SKB264.
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
- The study aims to see if sac‑TMT, with or without bevacizumab, keeps cancer from getting worse longer than standard care. It compares survival without disease progression.
- Who it's for
- It looks for adults who have advanced ovarian cancer and have finished surgery and chemotherapy.
- What's involved
- Participants may receive sac‑TMT alone or with bevacizumab, or standard care. They will have regular clinic visits and tests to monitor cancer status.
- Time commitment
- The trial lasts about 2–3 years, with scheduled visits every few weeks to months for treatment and monitoring.
- 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
- 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.
- Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
You likely can't join if
- 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.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected...
See the full eligibility criteria
- 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
- 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 is enrolling
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Highlands Ranch, Colorado, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Arlington Heights, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Covington, Louisiana, United States
- Scarborough, Maine, United States
- Columbia, Maryland, United States
- Omaha, Nebraska, United States
- Reno, Nevada, United States
- Albany, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
+ 136 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; La Jolla, California, United States; Walnut Creek, California, United States; Aurora, Colorado, United States; Highlands Ranch, Colorado, United States; Miami Beach, Florida, United States and 150 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.