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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Sacituzumab tirumotecan + Bevacizumab 		Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks
  • Biological: Sacituzumab tirumotecan
    IV Infusion
    Other names:
    • MK-2870
    • sac-TMT
    • SKB264
  • Biological: Bevacizumab
    IV Infusion
    Other names:
    • Avastin
    • Altusan
    • MVASI
  • Drug: H1 receptor antagonist
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: H2 receptor antagonist
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: Acetaminophen (or equivalent)
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: Dexamethasone (or equivalent)
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: Steroid mouthwash (dexamethasone or equivalent)
    Rescue medication taken orally 4 times daily
Experimental
Part 2: Sacituzumab tirumotecan 		Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.
  • Biological: Sacituzumab tirumotecan
    IV Infusion
    Other names:
    • MK-2870
    • sac-TMT
    • SKB264
  • Biological: Bevacizumab
    IV Infusion
    Other names:
    • Avastin
    • Altusan
    • MVASI
  • Drug: H1 receptor antagonist
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: H2 receptor antagonist
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: Acetaminophen (or equivalent)
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: Dexamethasone (or equivalent)
    Rescue medication taken per approved product label before sacituzumab tirumotecan
  • Drug: Steroid mouthwash (dexamethasone or equivalent)
    Rescue medication taken orally 4 times daily
Active Comparator
Part 2: Standard of care (SOC) 		Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.
  • Biological: Bevacizumab
    IV Infusion
    Other names:
    • Avastin
    • Altusan
    • MVASI

Recruiting Locations

Sarasota Memorial Hospital ( Site 0075)
Sarasota, Florida 34239
Contact:
Study Coordinator
941-917-2225

St. Dominic's Hospital ( Site 0064)
Jackson, Mississippi 39216
Contact:
Study Coordinator
888-577-8839

Nebraska Methodist Hospital ( Site 0053)
Omaha, Nebraska 68114
Contact:
Study Coordinator
402-354-8534

Rutgers Cancer Institute of New Jersey ( Site 0071)
New Brunswick, New Jersey 08901
Contact:
Study Coordinator
732-235-7258

University of Cincinnati Medical Center ( Site 0090)
Cincinnati, Ohio 45219
Contact:
Study Coordinator
513-584-1958

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
Tulsa, Oklahoma 74146
Contact:
Study Coordinator
918-505-3200

Women & Infants Hospital ( Site 0050)
Providence, Rhode Island 02905
Contact:
Study Coordinator
401-274-1100

More Details

NCT ID
NCT06824467
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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