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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 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

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 2-4 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 2-4 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

University of Alabama at Birmingham ( Site 0006)
Birmingham, Alabama 35249
Contact:
Study Coordinator
(205) 934-7442

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)
New Haven, Connecticut 06510
Contact:
Study Coordinator
203-785-5702

Mount Sinai Cancer Center ( Site 0078)
Miami Beach, Florida 33140
Contact:
Study Coordinator
305-674-2625

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

Florida Cancer Specialists East ( Site 7000)
West Palm Beach, Florida 33401
Contact:
Study Coordinator
561-366-4100

Winship Cancer Institute of Emory University ( Site 0086)
Atlanta, Georgia 30322
Contact:
Study Coordinator
404-778-1900

Augusta University - Georgia Cancer Center ( Site 0066)
Augusta, Georgia 30912
Contact:
Study Coordinator
706-721-6744

Parkview Research Center at Parkview Regional Medical Center ( Site 0003)
Fort Wayne, Indiana 46845
Contact:
Study Coordinator
260-425-6981

Women's Cancer Care ( Site 0067)
Covington, Louisiana 70433
Contact:
Study Coordinator
985-892-2252

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)
Scarborough, Maine 04074
Contact:
Study Coordinator
207-883-0069

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 New Mexico Comprehensive Cancer Center ( Site 0055)
Albuquerque, New Mexico 87131
Contact:
Study Coordinator
505-272-4946

NYU Langone Hospital - Long Island ( Site 0015)
Mineola, New York 11501
Contact:
Study Coordinator
516-663-0333

Laura and Isaac Perlmutter Cancer Center ( Site 0076)
New York, New York 10016
Contact:
Study Coordinator
212-731-6000

FirstHealth Cancer Center ( Site 0079)
Pinehurst, North Carolina 28374
Contact:
Study Coordinator
910-715-8684

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

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)
Eugene, Oregon 97401
Contact:
Study Coordinator
541-683-5001

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

Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas 78758
Contact:
Study Coordinator
512-873-8900

Texas Oncology - DFW ( Site 8001)
Fort Worth, Texas 76104
Contact:
Study Coordinator
817-413-1500

Texas Oncology - San Antonio ( Site 8005)
San Antonio, Texas 78240
Contact:
Study Coordinator
210-595-5300

Texas Oncology - Gulf Coast ( Site 8003)
Webster, Texas 77598
Contact:
Study Coordinator
281-332-7505

Virginia Cancer Specialists (VCS) ( Site 8011)
Fairfax, Virginia 22031
Contact:
Study Coordinator
(571) 350-8400

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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