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)

Launched by MERCK SHARP & DOHME LLC · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called sacituzumab tirumotecan (MK-2870) for women with platinum-sensitive recurrent ovarian cancer. The trial aims to find out if this treatment is safe and if it helps patients live longer without their cancer getting worse compared to standard treatments currently available. Additionally, the study will look at how well participants tolerate the treatment, especially when combined with another medication called bevacizumab.

To be eligible for this trial, participants must be women aged 65 and older who have been diagnosed with certain types of ovarian cancer and have already received specific chemotherapy treatments. They should have a good performance status, meaning they are able to carry out daily activities with little to no difficulty. Participants will receive either the new treatment or the standard care and will be monitored throughout the study. It’s important to know that individuals with certain health conditions or previous treatments may not qualify for this trial. If you or a loved one might be interested in participating, it could be a good opportunity to receive potentially effective care while contributing to important cancer research.

Gender

FEMALE

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 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 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 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