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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)

NCT06824467

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Interventions: Sacituzumab tirumotecan, Bevacizumab, H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent)

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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 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 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

Locations (186)

Birmingham, Alabama, United States
Anchorage, Alaska, United States
San Francisco, California, United States
Walnut Creek, California, United States
New Haven, Connecticut, United States
Miami Beach, Florida, United States
Sarasota, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Fort Wayne, Indiana, United States
Covington, Louisiana, United States
Scarborough, Maine, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
New York, New York, United States
Pinehurst, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Austin, Texas, United States
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