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RecruitingLast updated: 14 May 2026

TroFuse-022: Targeted immunotherapy drug called sacituzumab tirumotecan is, with or without additional targeted therapy, compared to standard of care treatment in people with recurrent ovarian cancerA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

TroFuse-022

Clinical summary

Summary

The main goals of this study are to learn about the safety of an antibody-drug conjugate called sacituzumab tirumotecan when given with bevacizumab targeted therapy,, including:

  • whether people can tolerate it
  • whether people who take sacituzumab tirumotecan, with or without bevacizumab, live longer without the cancer getting worse than those who receive standard of care treatment.

You may be eligible for this study is you have platinum-sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and have 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.

The study has two parts.

Part One
Participants will receive sacituzumab tirumotecan once every 2 weeks plus bevacizumab once every 3 weeks via intravenous (IV) infusion over 6 weeks.

Part Two
Participants will be randomly allocated to one of two treatment groups.

  • Experimental Group: sacituzumab tirumotecan every 2 weeks via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants may also receive bevacizumab every 3 weeks via IV infusion.
  • Active Comparator Group: local standard of care treatment. At the physician's discretion, participants may also receive bevacizumab every 3 weeks via IV infusion.

Conditions

This trial is treating people with platinum-sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer

Eligibility

Inclusion

clusion Criteria:

  • Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV 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 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

  • 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 or has current pneumonitis/ILD
  • 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06824467 *
  • 2023-508015-23-00 *
  • 2870-022; MK-2870-022; TROFUSE-022; U1111-1297-4489; GOG-3103; ENGOT-OV84; JRCT2031240722

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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)

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