NCT06824467 · Merck Sharp & Dohme LLC
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
What this study is about
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive the usual treatment treatment.
View original scientific description
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
Interventions
BIOLOGICAL
Sacituzumab tirumotecan
IV Infusion
BIOLOGICAL
Bevacizumab
IV Infusion
DRUG
H1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
DRUG
H2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
DRUG
Acetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
DRUG
Dexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
DRUG
Steroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 2-4 times daily
Primary outcome measures
Part 1: Number of participants with one or more adverse events (AEs)
Time frame: Up to 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Part 1: Number of participants who discontinue study intervention due to an AE
Time frame: Up to 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Part 2: Progression-free Survival (PFS)
Time frame: Up to approximately 4 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 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 1) or randomization (Part 2)
- 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 to 1 assessed within 7 days before
Where
- Birmingham, Alabama
- Anchorage, Alaska
- San Francisco, California
- New Haven, Connecticut
- Miami Beach, Florida
- Sarasota, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Augusta, Georgia
- Fort Wayne, Indiana
- Covington, Louisiana
- Scarborough, Maine
And 21 more locations — see the full list below.
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations