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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06824467

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (biological), Bevacizumab (biological), H1 receptor antagonist (drug), H2 receptor antagonist (drug)
How long the study runs
Study runs about 91 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — biological: IV Infusion · Bevacizumab — biological: IV Infusion · H1 receptor antagonist — drug: Rescue medication taken per approved product label before sacituzumab tirumotecan · H2 receptor antagonist — drug: Rescue medication taken per approved product label before sacituzumab tirumotecan · Acetaminophen (or equivalent) — drug: Rescue medication taken per approved product label before sacituzumab tirumotecan · Dexamethasone (or equivalent) — drug: Rescue medication taken per approved product label before sacituzumab tirumotecan · Steroid mouthwash (dexamethasone or equivalent) — drug: Rescue medication taken orally 2-4 times daily
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
770
Started
2025-04-09
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ovarian cancer
  • • Phase3 - 770 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ovarian cancer
  • • Female only

Where?

  • • Cambridge - Cambridge University Hospital ( Site 2803)
  • • Edinburgh - Western General Hospital ( Site 2806)
  • • Preston - Royal Preston Hospital ( Site 2807)
  • • London - ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

antigen positive

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy

What the study is looking for

  • ✓Has that has grown locally or that has spread, confirmed by a biopsy epithelial ovarian, primary peritoneal, or fallopian...
  • ✓Has received 4 or more cycles of platinum-based doublet drug treatment in first-line and a total of 6 to 8 cycles of...
  • ✓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

Who cannot take part

  • ✗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...
  • ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory...
  • ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • ✗HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
See the full criteria
Inclusion 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 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 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2) Exclusion Criteria: * 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 Screening * 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

Where Is This Study? (8 UK sites)

Cambridge University Hospital ( Site 2803)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01223 216083

Western General Hospital ( Site 2806)

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441315371000

Royal Preston Hospital ( Site 2807)

Preston PR2 9HT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01772 524656

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02089156899

Royal Marsden Hospital (Sutton) ( Site 2802)

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02089156899

Queen Elizabeth Hospital Birmingham ( Site 2804)

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0121 371 8766

Leicester Royal Infirmary ( Site 2808)

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0300 303 1573

Clatterbridge Cancer Centre - Liverpool ( Site 2805)

Liverpool L7 8YA, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0151 556 5000

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10