Purpose

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: - Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. - Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Conditions

Eligibility

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

Inclusion Criteria

include but are not limited to the following: - Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present. - Has completed primary debulking surgery or interval debulking surgery. - Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol. - Has provided tumor tissue that is not previously irradiated. - Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV - Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive. - Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection. The main

Exclusion Criteria

include but are not limited to the following: - Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has a history of severe eye disease. - Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease. - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. - Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening. - Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria. - Had a live or live-attenuated vaccine within 30 days of randomization. - Has a known additional malignancy that is progressing or required active treatment within the past 3 years. - Has active infection requiring systemic therapy. - Has concurrent and active HBV and HCV infections. - Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease. - Has not recovered from major surgery or has ongoing surgical complications. - Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory. - Active or ongoing stomatitis of any grade.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
  • Drug: Sacituzumab tirumotecan
    Administered via intravenous (IV) infusion at a dose of 4mg/kg
    Other names:
    • sac-TMT
    • MK-2870
    • SKB264
  • Drug: Bevacizumab
    Administered via IV infusion at a dose of 15mg/kg
    Other names:
    • Avastin
    • Altuzan
    • MVASI
  • Drug: Rescue Medications
    Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.
Active Comparator
Standard of Care
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.
  • Drug: Bevacizumab
    Administered via IV infusion at a dose of 15mg/kg
    Other names:
    • Avastin
    • Altuzan
    • MVASI

Recruiting Locations

University of Alabama - Birmingham ( Site 0058)
Birmingham, Alabama 35233
Contact:
Study Coordinator
205-934-4986

John Muir Health Cancer Center ( Site 0069)
Walnut Creek, California 94598
Contact:
Study Coordinator
925-692-5603

Mount Sinai Cancer Center ( Site 0029)
Miami Beach, Florida 33140
Contact:
Study Coordinator
305-674-2625

Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)
Orlando, Florida 32806
Contact:
Study Coordinator
321-841-8393

Winship Cancer Institute of Emory University ( Site 0037)
Atlanta, Georgia 30308
Contact:
Study Coordinator
404-778-1900

Illinois Cancer Specialists (ICS) ( Site 8009)
Arlington Heights, Illinois 60005
Contact:
Study Coordinator
847-259-4482

Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
Fort Wayne, Indiana 46845
Contact:
Study Coordinator
206-266-7701

Franciscan Health Indianapolis ( Site 0081)
Indianapolis, Indiana 46237
Contact:
Study Coordinator
317-528-5000

Women's Cancer Care ( Site 0018)
Covington, Louisiana 70433
Contact:
Study Coordinator
985-892-2252

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)
Scarborough, Maine 04074
Contact:
Study Coordinator
207-883-0069

Maryland Oncology Hematology, P.A. ( Site 8002)
Columbia, Maryland 21044
Contact:
Study Coordinator
410-964-2212

Nebraska Methodist Hospital ( Site 0004)
Omaha, Nebraska 68114
Contact:
Study Coordinator
402-354-7939

University Of Nebraska Medical Center ( Site 0035)
Omaha, Nebraska 68198
Contact:
Study Coordinator
402-559-2000

The Center of Hope ( Site 0025)
Reno, Nevada 89511
Contact:
Study Coordinator
775-327-4673

Womens Cancer Care Associates, LLC ( Site 0023)
Albany, New York 12208-1743
Contact:
Study Coordinator
518-458-1390

Memorial Sloan Kettering Cancer Center ( Site 0072)
New York, New York 10022
Contact:
Study Coordinator
347-923-8746

Duke Cancer Center ( Site 0012)
Durham, North Carolina 27710
Contact:
Study Coordinator
919-681-6900

University of Cincinnati Medical Center ( Site 0042)
Cincinnati, Ohio 45219
Contact:
Study Coordinator
513-584-1000

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
Tulsa, Oklahoma 74146
Contact:
Study Coordinator
918-505-3200

Hospital of the University of Pennsylvania ( Site 0071)
Philadelphia, Pennsylvania 19104
Contact:
Study Coordinator
215-662-4000

Women & Infants Hospital ( Site 0001)
Providence, Rhode Island 02905
Contact:
Study Coordinator
401-274-1122x48181

West Cancer Center and Research Institute ( Site 0013)
Germantown, Tennessee 38138
Contact:
Study Coordinator
901-683-0055

University of Tennessee Medical Center ( Site 0087)
Knoxville, Tennessee 37920
Contact:
Study Coordinator
865-305-9000

Henry-Joyce Cancer Clinic ( Site 0011)
Nashville, Tennessee 37232
Contact:
Study Coordinator
615-936-4585

Virginia Cancer Specialists (VCS) ( Site 8012)
Fairfax, Virginia 22031
Contact:
Study Coordinator
703-280-5390

Virginia Oncology Associates (VOA) ( Site 8013)
Norfolk, Virginia 23502
Contact:
Study Coordinator
757-466-8663

More Details

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.