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Phase 3Recruiting

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Sponsored by Merck Sharp & Dohme LLC

About this study

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.

Where this study is enrolling (84)

  • Infirmary Cancer Care ( Site 0001)

    Mobile, Alabama

    Call 251-435-2273

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  • Ironwood Cancer & Research Centers-Research ( Site 0054)

    Chandler, Arizona

    Call 480-821-2838

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  • Kaiser Permanente - Walnut Creek ( Site 0078)

    Walnut Creek, California

    Call 877-642-4691

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  • MemorialCare Orange Coast Medical Center ( Site 9501)

    Fountain Valley, California

    Call 714-378-7000

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  • Kaiser Permanente Vallejo Medical Center ( Site 0060)

    Vallejo, California

    Call 877-642-4691

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Show all 84 locations

  • Kaiser Permanente - San Francisco ( Site 0080)

    San Francisco, California

    Call 877-642-4691

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  • Profound Research LLC ( Site 0105)

    Oceanside, California

    Call 760-826-2020

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  • Providence Medical Foundation ( Site 9543)

    Santa Rosa, California

    Call 707-528-1050

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  • Kaiser Permanente - Oakland ( Site 0079)

    Oakland, California

    Call 877-642-4691

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  • Kaiser Permanente - Santa Clara ( Site 0082)

    Santa Clara, California

    Call 877-642-4691

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  • Scripps Cancer Center ( Site 0052)

    La Jolla, California

    Call 800-727-4777

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  • Kaiser Permanente - Roseville ( Site 0081)

    Roseville, California

    Call 877-642-4691

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  • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)

    Grand Junction, Colorado

    Call 970-298-7500

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  • Yale Cancer Center ( Site 0053)

    New Haven, Connecticut

    Call 203-688-4242

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  • University of Connecticut Health Center ( Site 0128)

    Farmington, Connecticut

    Call 860-679-2100

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  • Helen F. Graham Cancer Center & Research Institute ( Site 0018)

    Newark, Delaware

    Call 302-366-1200

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  • Cleveland Clinic Martin North Hospital ( Site 0114)

    Stuart, Florida

    Call 772-419-2146

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  • Comprehensive Hematology Oncology ( Site 0091)

    St. Petersburg, Florida

    Call 727-344-6569

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  • Orlando Health Cancer Institute ( Site 0030)

    Orlando, Florida

    Call 321-843-8370

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  • AdventHealth Altamonte Springs ( Site 0125)

    Altamonte Springs, Florida

    Call 407-834-5151

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  • Orchard Healthcare Research Inc. ( Site 0014)

    Skokie, Illinois

    Call 224-534-7580

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  • Illinois Cancer Specialists (ICS) ( Site 8010)

    Arlington Heights, Illinois

    Call 847-259-4482

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  • Southern Illinois Hospital Services ( Site 9547)

    Carterville, Illinois

    Call 618-549-0721

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  • Parkview Research Center at Parkview Regional Medical Center ( Site 0011)

    Fort Wayne, Indiana

    Call 260-266-6313

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  • Northwest Cancer Center - Dyer Clinic ( Site 0097)

    Dyer, Indiana

    Call 615-785-5914

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  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)

    Edgewood, Kentucky

    Call 859-301-4000

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  • CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)

    Alexandria, Louisiana

    Call 318-528-6976

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  • Louisiana State University Health Sciences Shreveport ( Site 0029)

    Shreveport, Louisiana

    Call 318-813-1429

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  • Holy Cross Hospital ( Site 0069)

    Silver Spring, Maryland

    Call 301-754-7552

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  • University of Michigan ( Site 0103)

    Ann Arbor, Michigan

    Call 800-865-1125

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  • Henry Ford Health ( Site 0010)

    Detroit, Michigan

    Call 313-598-2556

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  • Metro-Minnesota Community Clinical Oncology ( Site 0031)

    Saint Louis Park, Minnesota

    Call 952-993-3252

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  • University of Mississippi Medical Center ( Site 0043)

    Jackson, Mississippi

    Call 601-984-5590

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  • Lake Regional Hospital ( Site 0009)

    Osage Beach, Missouri

    Call 573-302-2772

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  • Siteman Cancer Center ( Site 0099)

    St Louis, Missouri

    Call 314-362-0263

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  • Comprehensive Cancer Centers of Nevada - Peak ( Site 0047)

    Las Vegas, Nevada

    Call 702-609-9427

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  • Optum Care Cancer Center ( Site 9535)

    Las Vegas, Nevada

    Call 702-724-8787

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  • CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)

    Santa Fe, New Mexico

    Call 505-913-8953

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  • New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)

    Albuquerque, New Mexico

    Call 505-842-8171

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  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)

    New York, New York

    Call 212-604-6000

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  • Clinical Research Alliance ( Site 0086)

    Westbury, New York

    Call 516-734-8906

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  • Icahn School of Medicine at Mount Sinai ( Site 0123)

    New York, New York

    Call 212-241-3300

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  • Memorial Sloan Kettering Cancer Center ( Site 0067)

    New York, New York

    Call 212-639-2000

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  • Cape Fear Valley Health System ( Site 0136)

    Fayetteville, North Carolina

    Call 472-210-8847

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  • Levine Cancer Institute ( Site 0083)

    Charlotte, North Carolina

    Call 980-442-3130

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  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)

    Fargo, North Dakota

    Call 701-234-2000

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  • Altru Cancer Center ( Site 0104)

    Grand Forks, North Dakota

    Call 701-780-5451

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  • Sanford Cancer Center Bismarck ( Site 0058)

    Bismarck, North Dakota

    Call 701-323-5741

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  • Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)

    Massillon, Ohio

    Call 330-478-0001

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  • Genesis Healthcare System ( Site 0025)

    Zanesville, Ohio

    Call 740-454-5271

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  • Cleveland Clinic - Mercy Hospital ( Site 0057)

    Canton, Ohio

    Call 330-489-1274

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  • Taylor Cancer Research Center ( Site 9500)

    Maumee, Ohio

    Call 567-402-4501

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  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)

    Tulsa, Oklahoma

    Call 918-505-3200

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  • Providence Portland Medical Center ( Site 0116)

    Portland, Oregon

    Call 503-215-1979

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  • Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)

    Portland, Oregon

    Call 503-215-1979

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  • Cancer Care Associates Of York ( Site 9517)

    York, Pennsylvania

    Call 717-741-9229

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  • Sidney Kimmel Cancer Center at Jefferson ( Site 0049)

    Philadelphia, Pennsylvania

    Call 215-955-8874

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  • Sanford Cancer Center ( Site 0059)

    Sioux Falls, South Dakota

    Call 605-328-8000

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  • Tennessee Oncology ( Site 0111)

    Nashville, Tennessee

    Call 615-986-4350

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  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee

    Call 615-329-7274

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  • Vanderbilt Health One Hundred Oaks ( Site 0042)

    Nashville, Tennessee

    Call 800-811-8480

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  • Baptist Cancer Center ( Site 0101)

    Memphis, Tennessee

    Call 901-226-3077

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  • One Oncology - Tennessee Oncology ( Site 0098)

    Nashville, Tennessee

    Call 615-986-4350

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  • West Cancer Center and Research Institute ( Site 0084)

    Germantown, Tennessee

    Call 901-683-0055

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  • University of Texas Southwestern Medical Center ( Site 0032)

    Dallas, Texas

    Call 214-645-4673

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  • Hendrick Medical Center ( Site 0117)

    Abilene, Texas

    Call 325-670-2000

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  • Parkland Health & Hospital System ( Site 0096)

    Dallas, Texas

    Call 214-645-4673

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  • Harrington Cancer Center ( Site 0061)

    Amarillo, Texas

    Call 806-359-4673

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  • John Peter Smith Hospital ( Site 0106)

    Fort Worth, Texas

    Call 817-702-8049

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  • Laguna Clinical Research Associates LLC ( Site 0068)

    Laredo, Texas

    Call 956-724-8543

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  • Mays Cancer Center ( Site 0122)

    San Antonio, Texas

    Call 210-450-1000

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  • Texas Oncology - DFW ( Site 8000)

    Dallas, Texas

    Call 214-370-1000

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  • Texas Oncology - Gulf Coast ( Site 8009)

    Webster, Texas

    Call 281-332-7505

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  • Texas Oncology - Northeast Texas ( Site 8005)

    Flower Mound, Texas

    Call 972-537-4100

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  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)

    Tyler, Texas

    Call 903-592-6152

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  • Oncology Consultants P.A. ( Site 0107)

    Houston, Texas

    Call 855-827-9525

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  • Intermountain Medical Center ( Site 0113)

    Murray, Utah

    Call 801-507-3630

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  • Hematology Oncology Associates of Fredericksburg ( Site 9550)

    Fredericksburg, Virginia

    Call 540-371-0079

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  • Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)

    Midlothian, Virginia

    Call 804-893-8717

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  • Virginia Oncology Associates (VOA) ( Site 8008)

    Norfolk, Virginia

    Call 646-694-8125

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  • Mary Washington Hospital ( Site 0129)

    Fredericksburg, Virginia

    Call 540-300-6182

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  • Virginia Cancer Institute ( Site 0034)

    Richmond, Virginia

    Call 804-287-3000

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  • Northwest Medical Specialties, PLLC ( Site 0093)

    Tacoma, Washington

    Call 253-428-8700

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  • SSM Health Dean Medical Group ( Site 0087)

    Madison, Wisconsin

    Call 516-488-2918

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Who can participate

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 16 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 severe 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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.