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)

Last updated: May 28, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Ovarian Cancer

Fallopian Tube Cancer

Pelvic Cancer

Treatment

Acetaminophen (or equivalent)

Dexamethasone (or equivalent)

Bevacizumab

Clinical Study ID

NCT06824467
2870-022
U1111-1297-4489
jRCT2031240722
ENGOT-ov84
GOG-3103
TroFuse-022
2023-508015-23
MK-2870-022
2023-508015-23-00
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has histologically confirmed epithelial ovarian, fallopian tube, or primaryperitoneal carcinoma.

  • Has received 4 or more cycles of platinum-based doublet chemotherapy in first-lineand a total of 6 cycles of carboplatin-based doublet chemotherapy in second-linesetting 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 controlledHIV on antiretroviral therapy

  • Participants who are hepatitis B surface antigen positive are eligible if they havereceived hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and haveundetectable 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 HCVviral load is undetectable at screening

  • Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

Exclusion

Exclusion Criteria:

  • Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderlinetumors (low malignant potential), mucinous, seromucinous that is predominantlymucinous, 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 diseaseand/or blepharitis, or severe corneal disease that prevents/delays corneal healing.

  • Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease (e.g. Crohn's disease, ulcerativecolitis, or chronic diarrhea)

  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.

  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.

  • HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman'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) orrandomization (Part 2), or has radiation related toxicities, requiringcorticosteroids

  • Has an additional malignancy that is progressing or has required active treatmentwithin the past 3 years

  • Has active central nervous system (CNS) metastases and/or carcinomatous meningitis

  • Has an active infection requiring systemic therapy

Study Design

Total Participants: 770
Treatment Group(s): 7
Primary Treatment: Acetaminophen (or equivalent)
Phase: 3
Study Start date:
April 09, 2025
Estimated Completion Date:
October 15, 2032

Connect with a study center

  • Gallipoli Medical Research Ltd ( Site 0214)

    Brisbane, Queensland 4120
    Australia

    Active - Recruiting

  • Epworth Freemasons ( Site 0217)

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Kurume University Hospital ( Site 1640)

    Kurume, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center ( Site 1632)

    Hidaka, Saitama 350-1298
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR ( Site 1639)

    Koto, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Niigata Cancer Center Hospital ( Site 1633)

    Niigata, 951-8566
    Japan

    Active - Recruiting

  • National Cancer Center ( Site 2305)

    Goyang-si, Kyonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital ( Site 2302)

    Seodaemun-Gu, Seoul 03722
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center ( Site 2304)

    Songpa-gu, Seoul 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 2303)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 2301)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Girona ( Site 2402)

    Girona, Gerona 17007
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra ( Site 2407)

    Madrid, Madrid, Comunidad De 28027
    Spain

    Active - Recruiting

  • Hospital Vall D Hebron ( Site 2403)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • ICO L Hospitalet ( Site 2408)

    Barcelona, 08907
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia ( Site 2406)

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 2603)

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 2602)

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 2604)

    Taipei, 104
    Taiwan

    Active - Recruiting

  • Sarasota Memorial Hospital ( Site 0075)

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • St. Dominic's Hospital ( Site 0064)

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Nebraska Methodist Hospital ( Site 0053)

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 0071)

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center ( Site 0090)

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Women & Infants Hospital ( Site 0050)

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

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