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)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06824467

This study assesses the safety and efficacy of sacituzumab tirumotecan, with or without bevacizumab, in platinum-sensitive recurrent ovarian cancer. Eligible participants have confirmed epithelial ovarian cancer and meet specific treatment history and health criteria. Interventions include IV infusions and rescue medications like H1/H2 antagonists, acetaminophen, dexamethasone, and steroid mouthwash.

Patient Parameters

Program Overview

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 Criteria

  • Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • 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 to 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), 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 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 that required steroids or has current pneumonitis/interstitial lung disease.
  • 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
  • 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

Locations

FACILITYZIPCITYSTATE
Nebraska Methodist Hospital ( Site 0053)68114OmahaNebraska

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