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Clinical Trials in the USA / NCT06393374
Recruiting Phase 3

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

NCT06393374 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2024-06-24
Last updated
2026-09-11

Condition(s) studied

Triple-Negative Breast Cancer

Investigational drug(s) / intervention(s)

PembrolizumabSacituzumab tirumotecanCapecitabine

Pembrolizumab: Pembrolizumab 400 mg intravenous (IV) infusion q6w

Sacituzumab tirumotecan: Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

Capecitabine: Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 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

Primary outcome measure(s)

Trial sites (310)

FacilityCityRegionStatus
Infirmary Cancer Care ( Site 0001) Mobile Alabama Recruiting
Ironwood Cancer & Research Centers-Research ( Site 0054) Chandler Arizona Recruiting
MemorialCare Orange Coast Medical Center ( Site 9501) Fountain Valley California Recruiting
Scripps Cancer Center ( Site 0052) La Jolla California Recruiting
Cancer and Blood Specialty Clinic ( Site 0008) Los Alamitos California Completed
Kaiser Permanente - Oakland ( Site 0079) Oakland California Recruiting
Profound Research LLC ( Site 0105) Oceanside California Recruiting
Kaiser Permanente - Roseville ( Site 0081) Roseville California Recruiting
Kaiser Permanente - San Francisco ( Site 0080) San Francisco California Recruiting
Kaiser Permanente - Santa Clara ( Site 0082) Santa Clara California Recruiting
Providence Medical Foundation ( Site 9543) Santa Rosa California Recruiting
Kaiser Permanente Vallejo Medical Center ( Site 0060) Vallejo California Recruiting
Kaiser Permanente - Walnut Creek ( Site 0078) Walnut Creek California Recruiting
Bass Medical Group ( Site 0089) Walnut Creek California Completed
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046) Grand Junction Colorado Recruiting
University of Connecticut Health Center ( Site 0128) Farmington Connecticut Recruiting
Yale Cancer Center ( Site 0053) New Haven Connecticut Recruiting
Helen F. Graham Cancer Center & Research Institute ( Site 0018) Newark Delaware Recruiting
AdventHealth Altamonte Springs ( Site 0125) Altamonte Springs Florida Recruiting
Orlando Health Cancer Institute ( Site 0030) Orlando Florida Recruiting
Comprehensive Hematology Oncology ( Site 0091) St. Petersburg Florida Recruiting
Cleveland Clinic Martin North Hospital ( Site 0114) Stuart Florida Recruiting
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040) Thomasville Georgia Completed
Illinois Cancer Specialists (ICS) ( Site 8010) Arlington Heights Illinois Recruiting
Orchard Healthcare Research Inc. ( Site 0014) Skokie Illinois Recruiting
Northwest Cancer Center - Dyer Clinic ( Site 0097) Dyer Indiana Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0011) Fort Wayne Indiana Recruiting
Cancer Center of Kansas ( Site 0004) Wichita Kansas Completed
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044) Edgewood Kentucky Recruiting
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109) Alexandria Louisiana Recruiting
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063) Monroe Louisiana Completed
Louisiana State University Health Sciences Shreveport ( Site 0029) Shreveport Louisiana Recruiting
Holy Cross Hospital ( Site 0069) Silver Spring Maryland Recruiting
University of Michigan ( Site 0103) Ann Arbor Michigan Recruiting
Henry Ford Health ( Site 0010) Detroit Michigan Recruiting
Profound Research LLC ( Site 0074) Royal Oak Michigan Completed
Metro-Minnesota Community Clinical Oncology ( Site 0031) Saint Louis Park Minnesota Recruiting
University of Mississippi Medical Center ( Site 0043) Jackson Mississippi Recruiting
SSM Health Cancer Care - Fenton ( Site 0088) Fenton Missouri Completed
Lake Regional Hospital ( Site 0009) Osage Beach Missouri Recruiting

+ 270 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06393374 on ClinicalTrials.gov ↗ ← All trials in the USA