Comparing 3 approaches 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)
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
- Phase 3
- 3 groups
- Sites in Calgary, Greater Sudbury and 3 more cities
- Recruiting
Interventions (7)
- Biological therapy
Sacituzumab tirumotecan
IV Infusion
- Biological therapy
Bevacizumab
IV Infusion
- Medication
H1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
- Medication
H2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
- Medication
Acetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
- Medication
Dexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
- Medication
Steroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 2-4 times daily
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0512)
Calgary, Alberta
- Recruiting
Health Sciences North Research Institute ( Site 0517)
Greater Sudbury, Ontario
- Recruiting
Trillium Health Partners - Credit Valley Hospital ( Site 0508)
Mississauga, Ontario
- Recruiting
Princess Margaret Cancer Centre ( Site 0518)
Toronto, Ontario
- Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0505)
Montreal, Quebec
- Recruiting
McGill University Health Centre ( Site 0502)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (Part 2)
- +Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
- +Has platinum-sensitive epithelial OC
- +Has provided tissue of a tumor lesion that was not previously irradiated
- +Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
- +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)
Exclusion
- −HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- −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 mucinous, malignant Brenner's tumor and undifferentiated carcinoma
- −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 assessments at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (Part 2)
- −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
- −Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
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.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Sacituzumab tirumotecan and Bevacizumab, together with one or more of: H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent), Dexamethasone (or equivalent) and Steroid mouthwash (dexamethasone or equivalent).
Registry label: A: Part 1: Sacituzumab tirumotecan + Bevacizumab
Group B receives Sacituzumab tirumotecan, together with one or more of: Bevacizumab, H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent), Dexamethasone (or equivalent) and Steroid mouthwash (dexamethasone or equivalent).
Registry label: B: Part 2: Sacituzumab tirumotecan
Group C, the comparison group, receives Bevacizumab.
Registry label: C: Part 2: Standard of care (SOC)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
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.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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 770 people.
The study is currently expected to finish around November 2032.
The main measurement is taken over: Up to 6 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Part 1: Number of Participants With One or More Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to 6 weeks.
Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE — measured over Up to 6 weeks.
Part 2: Progression-Free Survival (PFS) — measured over Up to approximately 4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06824467 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 tirumotecanBiological
IV Infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About BevacizumabBiological
IV Infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About H1 receptor antagonistDrug
Rescue medication taken per approved product label before sacituzumab tirumotecan
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 H2 receptor antagonistDrug
Rescue medication taken per approved product label before sacituzumab tirumotecan
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 Acetaminophen (or equivalent)Drug
Rescue medication taken per approved product label before sacituzumab tirumotecan
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 Dexamethasone (or equivalent)Drug
Rescue medication taken per approved product label before sacituzumab tirumotecan
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 Steroid mouthwash (dexamethasone or equivalent)Drug
Rescue medication taken orally 2-4 times daily
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?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
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 6 weeks.
The study as a whole is currently expected to finish around 2032-11-09.
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 770 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Calgary, Alberta, Canada; Greater Sudbury, Ontario, Canada; Mississauga, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Maplewood, Minnesota, United States, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Minnesota Oncology Hematology (MNO) ( Site 8002)
Maplewood, Minnesota, United States
NYU Langone Hospital - Long Island ( Site 0015)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0076)
New York, New York, United States
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
Ask someone to help you approach it
Someone at Concord will read your request and email you. The study team decides who takes part.
Or answer a few questions to see which studies in Canada are closest to what you described.
This 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.