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Purpose

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines - Has no evidence of locoregional or distant relapse, as assessed by the treating physician - Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC - Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery - Has non-pathologic complete response at surgery - Is able to continue on adjuvant pembrolizumab - Randomization must be conducted within 12 weeks from surgical resection - Completed adjuvant radiation therapy (if indicated) and recovered before randomization - Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status - If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine [no restriction for pembrolizumab]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception - For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention - Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia) - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization

Exclusion Criteria

  • Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available - Has Grade >2 peripheral neuropathy - History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention - Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC - Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy - Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks - Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137) - Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization - Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration - Has known additional malignancy that is progressing or has required active treatment within the past 5 years - Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication - Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed - Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has active infection requiring systemic therapy - HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has concurrent active hepatitis B and hepatitis C virus infection - Has history of allogeneic tissue/solid organ transplant

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
Pembrolizumab + sacituzumab tirumotecan 		Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
  • Biological: Pembrolizumab
    Pembrolizumab 400 mg intravenous (IV) infusion q6w
    Other names:
    • KEYTRUDA®
    • MK-3475
    • SCH 900475
  • Biological: Sacituzumab tirumotecan
    Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
    Other names:
    • MK-2870
Active Comparator
Treatment of Physician's Choice 		Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily [BID] on Days 1 to 14 and 22 to 35 every 42 days x 4 [2 weeks 1, 1 week off]) for 24 weeks.
  • Biological: Pembrolizumab
    Pembrolizumab 400 mg intravenous (IV) infusion q6w
    Other names:
    • KEYTRUDA®
    • MK-3475
    • SCH 900475
  • Drug: Capecitabine
    Capecitabine 1000 mg/m^2 to 1250 mg/m^2 by mouth BID
    Other names:
    • XELODA

Recruiting Locations

Infirmary Cancer Care ( Site 0001)
Mobile, Alabama 36607
Contact:
Study Coordinator
251-435-2273

Ironwood Cancer & Research Centers-Research ( Site 0054)
Chandler, Arizona 85224
Contact:
Study Coordinator
480-821-2838

Scripps Cancer Center ( Site 0052)
La Jolla, California 92037
Contact:
Study Coordinator
800-727-4777

Cancer and Blood Specialty Clinic ( Site 0008)
Los Alamitos, California 90720
Contact:
Study Coordinator
562-353-1200

Bass Medical Group ( Site 0089)
Walnut Creek, California 94598
Contact:
Study Coordinator
925-433-8786

Yale Cancer Center ( Site 0053)
New Haven, Connecticut 06510
Contact:
Study Coordinator
203-688-4242

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
Thomasville, Georgia 31792
Contact:
Study Coordinator
229-584-5400

Orchard Healthcare Research Inc. ( Site 0014)
Skokie, Illinois 60077
Contact:
Study Coordinator
224-534-7580

Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
Fort Wayne, Indiana 46845
Contact:
Study Coordinator
260-266-6313

Cancer Center of Kansas ( Site 0004)
Wichita, Kansas 67214
Contact:
Study Coordinator
316-262-4467

Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
Monroe, Louisiana 71202
Contact:
Study Coordinator
318-330-7000

Louisiana State University Health Sciences Shreveport ( Site 0029)
Shreveport, Louisiana 71103
Contact:
Study Coordinator
318-813-1429

Profound Research LLC ( Site 0074)
Royal Oak, Michigan 48073
Contact:
Study Coordinator
248-551-2446

SSM Health Cancer Care - Fenton ( Site 0088)
Fenton, Missouri 63026
Contact:
Study Coordinator
636-496-4640

Lake Regional Hospital ( Site 0009)
Osage Beach, Missouri 65065
Contact:
Study Coordinator
573-302-2772

Memorial Sloan Kettering Cancer Center ( Site 0067)
New York, New York 10065
Contact:
Study Coordinator
212-639-2000

Clinical Research Alliance ( Site 0086)
Westbury, New York 11590
Contact:
Study Coordinator
516-734-8906

Sanford Cancer Center Bismarck ( Site 0058)
Bismarck, North Dakota 58501
Contact:
Study Coordinator
701-323-5741

Cleveland Clinic - Mercy Hospital ( Site 0057)
Canton, Ohio 44708
Contact:
Study Coordinator
330-489-1274

Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)
Massillon, Ohio 44646
Contact:
Study Coordinator
330-478-0001

Genesis Healthcare System ( Site 0025)
Zanesville, Ohio 43701
Contact:
Study Coordinator
888-577-8839

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
Tulsa, Oklahoma 74146
Contact:
Study Coordinator
918-505-3200

Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
Philadelphia, Pennsylvania 19107
Contact:
Study Coordinator
215-955-8874

Sanford Cancer Center ( Site 0059)
Sioux Falls, South Dakota 57104
Contact:
Study Coordinator
605-328-8000

Nashville General Hospital ( Site 0072)
Nashville, Tennessee 37208
Contact:
Study Coordinator
615-341-4383

Harrington Cancer Center ( Site 0061)
Amarillo, Texas 79106
Contact:
Study Coordinator
806-359-4673

Parkland Health & Hospital System ( Site 0096)
Dallas, Texas 75390
Contact:
Study Coordinator
214-645-4673

University of Texas Southwestern Medical Center ( Site 0032)
Dallas, Texas 75390
Contact:
Study Coordinator
214-645-4673

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (
Tyler, Texas 75701
Contact:
Study Coordinator
903-592-6152

Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)
Midlothian, Virginia 23114
Contact:
Study Coordinator
804-893-8717

Virginia Cancer Institute ( Site 0034)
Richmond, Virginia 23229
Contact:
Study Coordinator
804-287-3000

Northwest Medical Specialties, PLLC ( Site 0093)
Tacoma, Washington 98405
Contact:
Study Coordinator
253-428-8700

SSM Health Dean Medical Group ( Site 0087)
Madison, Wisconsin 53715
Contact:
Study Coordinator
516-488-2918

More Details

NCT ID
NCT06393374
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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