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)

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

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer

Eligibility

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

Inclusion Criteria

  • Has locally advanced or metastatic, histologically confirmed 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 to 8 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, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening - 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 for up to approximately 2 years or 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

Alaska Women's Cancer Care ( Site 0096)
Anchorage, Alaska 99508
Contact:
Study Coordinator
907-562-4673

UCSF Medical Center at Mission Bay ( Site 0013)
San Francisco, California 94158
Contact:
Study Coordinator
415-353-3000

John Muir Health Cancer Center ( Site 0016)
Walnut Creek, California 94598
Contact:
Study Coordinator
925-692-5603

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 Braman Comprehensive 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

Minnesota Oncology Hematology (MNO) ( Site 8002)
Maplewood, Minnesota 55109
Contact:
Study Coordinator
615-693-2574

Washington University School of Medicine ( Site 0052)
St Louis, Missouri 63110
Contact:
Study Coordinator
314-454-6215

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

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)
Hackensack, New Jersey 07601
Contact:
Study Coordinator
551-996-5855

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

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)
Columbus, Ohio 43210
Contact:
Study Coordinator
614-293-3300

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

Allegheny Health Network West Penn Hospital ( Site 0099)
Pittsburgh, Pennsylvania 15224
Contact:
Study Coordinator
412-578-5000

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

Henry-Joyce Cancer Clinic ( Site 0060)
Nashville, Tennessee 37232
Contact:
Study Coordinator
615-936-8422

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

University Of Texas Health Science Center -San Antonio ( Site 0095)
San Antonio, Texas 78229
Contact:
Study Coordinator
210-567-7000

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

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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