Trial comparing treatments for Ovarian Cancer
Official title A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
ClinicalTrials.gov ID: NCT06824467
What this study is testing
What is Sacituzumab tirumotecan?
An investigational IV infusion being studied as a potential treatment for ovarian cancer. It is designed to target the Trop‑2 protein on cancer cells and deliver a chemotherapy payload that interferes with DNA replication.
Also referred to as MK-2870, sac‑TMT, 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 learn how safe sacituzumab tirumotecan (with or without bevacizumab) is and whether it can keep the cancer from getting worse longer than standard treatment.
- Who it's for
- People whose ovarian, fallopian tube or primary peritoneal cancer has come back after platinum chemotherapy and is still sensitive to it.
- What's involved
- Participants will receive sacituzumab tirumotecan, sometimes together with bevacizumab, as ongoing treatment, while others receive the usual standard care. The study includes regular doctor visits, infusions, and tests to check safety and cancer status.
- 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 locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain...
- Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet...
- Has platinum-sensitive epithelial OC
- Has provided tissue of a tumor lesion that was not previously irradiated
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
You likely can't join if
- Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors...
- Has platinum-resistant OC or platinum-refractory OC
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays...
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected...
See the full eligibility criteria
- Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
- Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)
- Has platinum-sensitive epithelial OC
- Has provided tissue of a tumor lesion that was not previously irradiated
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part...
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
- Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly...
- Has platinum-resistant OC or platinum-refractory OC
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic...
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received more than 2 prior lines of systemic therapy for OC
- Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
- Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
- Has an additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active infection requiring systemic therapy
- Has active or ongoing stomatitis
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Duarte, California, United States
- Irvine, California, United States
- San Francisco, California, United States
- Walnut Creek, California, United States
- New Haven, Connecticut, United States
- Miami Beach, Florida, United States
- Sarasota, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Fort Wayne, Indiana, United States
- Westwood, Kansas, United States
- Covington, Louisiana, United States
- Scarborough, Maine, United States
- Maplewood, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
+ 155 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; Anchorage, Alaska, United States; Duarte, California, United States; Irvine, California, United States; San Francisco, California, United States; Walnut Creek, California, United States and 169 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.