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Looking for participantsPhase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06393374

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pembrolizumab (biological), Sacituzumab tirumotecan (biological), Capecitabine (drug)
How long the study runs
Study runs about 162 months (dates as stated)
About the drug or intervention
Pembrolizumab — biological: Pembrolizumab 400 mg intravenous (IV) infusion q6w · Sacituzumab tirumotecan — biological: Sacituzumab tirumotecan 4 mg/kg IV infusion q2w · Capecitabine — drug: Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,530
Started
2024-06-24
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for triple-negative breast cancer
  • • Phase3 - 1,530 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with triple-negative breast cancer

Where?

  • • Bristol - University Hospitals Bristol NHS Foundation Trust ( Site 2601)
  • • Hills Road - Addenbrooke's Hospital ( Site 2609)
  • • Truro - The Royal Cornwall Hospital ( Site 2603)
  • • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Triple-Negative Breast Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1CD137

Treatment history

Treatments you must have had:

  • ✓ recovered to ≤Grade 1 or baseline (except alopecia)
  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of...
  • ✓Has no evidence of locoregional or distant relapse, as assessed by the treating physician
  • ✓Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and...
  • ✓Has non-disease complete response at surgery
  • ✓Is able to continue on after surgery pembrolizumab

Who cannot take part

  • ✗Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for...
  • ✗Has Grade \>2 peripheral neuropathy
  • ✗History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal...
  • ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory...
  • ✗Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or...
See the full criteria
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

Where Is This Study? (7 UK sites)

University Hospitals Bristol NHS Foundation Trust ( Site 2601)

Bristol BS2 8ED, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator441173426733

Addenbrooke's Hospital ( Site 2609)

Hills Road CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01223216083

The Royal Cornwall Hospital ( Site 2603)

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01872258345

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 20 7377 7000

University College London Hospital ( Site 2604)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 20 3456 7890

Western General Hospital ( Site 2607)

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0300 123 1600

St James's University Hospital-Leeds Cancer Centre ( Site 2608)

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0113 243 3144

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10