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

Recruiting now · Phase 3

Conditions studied: Triple-Negative Breast Cancer

In brief

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.

Key facts

Study ID: NCT06393374
Run by: Merck Sharp & Dohme LLC
People needed: 1530
Starts: 2024-06-24
Expected to finish: 2037-12-14
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Parkview Research Center at Parkview Regional Medical Center ( Site 0011) — Fort Wayne, Indiana, United States (enrolling)
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044) — Edgewood, Kentucky, United States (enrolling)
Scripps Cancer Center ( Site 0052) — La Jolla, California, United States (enrolling)
Infirmary Cancer Care ( Site 0001) — Mobile, Alabama, United States (enrolling)
Kaiser Permanente - Oakland ( Site 0079) — Oakland, California, United States (enrolling)
MemorialCare Orange Coast Medical Center ( Site 9501) — Fountain Valley, California, United States (enrolling)
Kaiser Permanente - Roseville ( Site 0081) — Roseville, California, United States (enrolling)
Kaiser Permanente - San Francisco ( Site 0080) — San Francisco, California, United States (enrolling)
Kaiser Permanente - Santa Clara ( Site 0082) — Santa Clara, California, United States (enrolling)
Ironwood Cancer & Research Centers-Research ( Site 0054) — Chandler, Arizona, United States (enrolling)
Kaiser Permanente Vallejo Medical Center ( Site 0060) — Vallejo, California, United States (enrolling)
Kaiser Permanente - Walnut Creek ( Site 0078) — Walnut Creek, California, United States (enrolling)
Profound Research LLC ( Site 0105) — Oceanside, California, United States (enrolling)
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046) — Grand Junction, Colorado, United States (enrolling)
University of Connecticut Health Center ( Site 0128) — Farmington, Connecticut, United States (enrolling)
Yale Cancer Center ( Site 0053) — New Haven, Connecticut, United States (enrolling)
AdventHealth Altamonte Springs ( Site 0125) — Altamonte Springs, Florida, United States (enrolling)
Orlando Health Cancer Institute ( Site 0030) — Orlando, Florida, United States (enrolling)
Comprehensive Hematology Oncology ( Site 0091) — St. Petersburg, Florida, United States (enrolling)
Cleveland Clinic Martin North Hospital ( Site 0114) — Stuart, Florida, United States (enrolling)
Providence Medical Foundation ( Site 9543) — Santa Rosa, California, United States (enrolling)
Illinois Cancer Specialists (ICS) ( Site 8010) — Arlington Heights, Illinois, United States (enrolling)
Orchard Healthcare Research Inc. ( Site 0014) — Skokie, Illinois, United States (enrolling)
Northwest Cancer Center - Dyer Clinic ( Site 0097) — Dyer, Indiana, United States (enrolling)
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109) — Alexandria, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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