Comparing Sacituzumab tirumotecan with Bevacizumab for ovarian neoplasms
Official title: A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
Interventions
Sacituzumab tirumotecan
Administered via intravenous (IV) infusion at a dose of 4mg/kg
Bevacizumab
Administered via IV infusion at a dose of 15mg/kg
Rescue Medications
Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.
Canadian Sites (3)
CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)
Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0518)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0516)
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for40 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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.
- +Has concurrent and active HBV and HCV infections.
- +Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
- +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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → only if predominately (\>50%) Grade 3 features are present.
- +Has provided tumor tissue that is not previously irradiated.
- +The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Had a live or live-attenuated vaccine within 30 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
- +Has active infection requiring systemic therapy.
- +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.
- +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 protocolProtocolThe detailed plan a study must follow.Read more →.
- +Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →.
- +Has not recovered from major surgery or has ongoing surgical complications.
Exclusion
- −Has concurrent and active HBV and HCV infections.
- −Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
- −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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Had a live or live-attenuated vaccine within 30 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
- −Has active infection requiring systemic therapy.
- −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.
- −Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →.
- −Has not recovered from major surgery or has ongoing surgical complications.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Sacituzumab tirumotecan, Bevacizumab, Rescue Medications.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 900 people.
The study is currently expected to finish around February 2033.
The main measurement is taken over: Up to approximately 49 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival (PFS) — measured over Up to approximately 49 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07318558 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Sacituzumab tirumotecanDrug
Administered via intravenous (IV) infusion at a dose of 4mg/kg
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BevacizumabDrug
Administered via IV infusion at a dose of 15mg/kg
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Rescue MedicationsDrug
Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 49 months.
The study as a whole is currently expected to finish around 2033-02-25.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 900 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Chicoutimi, Quebec, Canada; Montreal, Quebec, Canada; Albany, New York, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (2)
Womens Cancer Care Associates, LLC ( Site 0023)
Albany, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0072)
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.