xMedica

NCT06393374ClinicalTrials.gov

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

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus 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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 1,530 مشاركاً311 موقعاً31 دولة

الفئات

علم الأورام76%الأمراض الجلدية24%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-05-01; recorded start 2024-06-24
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 661 other studies in this databaseCounted from the lead sponsor named in the record (Merck Sharp & Dohme LLC)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 305 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,530 participants (target), run at 311 sites, across 31 countries.

How this score is built
  • Enrolment32/40

    1,530 participants (target)

  • Site count25/25

    305 sites

  • Country count15/15

    31 countries

  • Planned duration10/10

    Planned over about 164 months

  • Sponsor scale10/10

    Merck Sharp & Dohme LLC has led 648 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

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.

الحالات

  • Triple-Negative Breast Cancer

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 1,530 مشاركاً

الجهة الراعية والمتعاونون

  • Merck Sharp & Dohme LLC الجهة الراعية

الأذرع والتدخلات

  • Pembrolizumab + sacituzumab tirumotecanEXPERIMENTAL

    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.

  • Treatment of Physician's ChoiceACTIVE_COMPARATOR

    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.

التدخلات

  • دواء Capecitabine

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

  • منتج بيولوجي Pembrolizumab

    Pembrolizumab 400 mg intravenous (IV) infusion q6w

  • منتج بيولوجي Sacituzumab tirumotecan

    Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Invasive Disease-Free Survival (iDFS)

    iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.

    الإطار الزمني Up to ~77 months

  2. مقياس النتيجة الثانوي

    Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    الإطار الزمني Up to ~101 months

  3. مقياس النتيجة الثانوي

    Distant recurrence-free survival (DRFS)

    DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.

    الإطار الزمني Up to ~101 months

  4. مقياس النتيجة الثانوي

    Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.

    الإطار الزمني Baseline and up to ~60 months

  5. مقياس النتيجة الثانوي

    Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning.

    الإطار الزمني Baseline and up to ~60 months

  6. مقياس النتيجة الثانوي

    Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning.

    الإطار الزمني Baseline and up to ~60 months

  7. مقياس النتيجة الثانوي

    Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1 = "Not at All" to 4 = "Very Much"). Lower scores indicate a better level of fatigue.

    الإطار الزمني Baseline and up to ~60 months

  8. مقياس النتيجة الثانوي

    Number of participants who experience one or more adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    الإطار الزمني Up to ~42 weeks

  9. مقياس النتيجة الثانوي

    Number of participants who discontinue study intervention due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    الإطار الزمني Up to 24 weeks

التواريخ

تاريخ البدء24 يونيو 2024 (فعلي)
الإتمام الأولي16 ديسمبر 2030 (تقديري)
الإتمام14 ديسمبر 2037 (تقديري)
أول نشر1 مايو 2024 (فعلي)
آخر تحديث17 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

298 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)Buenos Airesقيد التجنيد
Instituto de Oncología Angel H. Roffo ( Site 0503)Buenos AiresBuenos Aires F.D.قيد التجنيد
Instituto Alexander Fleming-Alexander Fleming ( Site 0509)Buenos AiresBuenos Aires F.D.قيد التجنيد
Sanatorio Finochietto ( Site 0513)Buenos Airesقيد التجنيد
Hospital Aleman-Oncology ( Site 0501)Capital FederalBuenos Airesقيد التجنيد
Hospital Británico de Buenos Aires-Oncology ( Site 0502)Ciudad Autónoma de Buenos AiresBuenos Airesقيد التجنيد
Sanatorio Parque ( Site 0512)RosarioSanta Fe Provinceقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)BrisbaneQueenslandقيد التجنيد
Frankston Hospital-Oncology and Haematology ( Site 2704)FrankstonVictoriaقيد التجنيد
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)Macquarie UniversityNew South Walesقيد التجنيد
Westmead Hospital ( Site 2700)WestmeadNew South Walesقيد التجنيد

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Medizinische Universitaet Innsbruck ( Site 1200)InnsbruckTyrolقيد التجنيد
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)LinzUpper Austriaقيد التجنيد
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)Salzburgقيد التجنيد
Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)Viennaقيد التجنيد
Klinikum Wels-Grieskirchen ( Site 1205)WelsUpper Austriaقيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)BrusselsBruxelles-Capitale, Region deقيد التجنيد
AZ Maria Middelares-IKG ( Site 0903)GhentOost-Vlaanderenقيد التجنيد
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)Namurقيد التجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
PRONUTRIR-CLINICAL RESEARCH ( Site 0609)FortalezaCearáقيد التجنيد
ANIMI - Unidade de Tratamento Oncologico ( Site 0616)LagesSanta Catarinaقيد التجنيد
Hospital do Câncer Mãe de Deus ( Site 0604)Porto AlegreRio Grande do Sulقيد التجنيد
Instituto de Oncologia Saint Gallen ( Site 0614)Santa Cruz do SulRio Grande do Sulقيد التجنيد
IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)São Pauloقيد التجنيد
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)TaubatéSão Pauloقيد التجنيد
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)TeresinaPiauíقيد التجنيد
Hospital Santa Rita de Cassia ( Site 0617)VitóriaEspírito Santoقيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Cross Cancer Institute ( Site 0407)EdmontonAlbertaقيد التجنيد
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)Greenfield ParkQuebecقيد التجنيد
QEII Health Sciences Centre - Victoria General Site ( Site 0418)HalifaxNova Scotiaقيد التجنيد
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0422)KingstonOntarioقيد التجنيد
The Moncton Hospital ( Site 0401)MonctonNew Brunswickقيد التجنيد
Jewish General Hospital ( Site 0416)MontrealQuebecقيد التجنيد
Centre Hospitalier de l'Université de Montréal ( Site 0403)MontrealQuebecقيد التجنيد
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)MontrealQuebecقيد التجنيد
Southlake Health ( Site 0413)NewmarketOntarioمكتمل
The Ottawa Hospital - General Campus ( Site 0414)OttawaOntarioقيد التجنيد
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)RimouskiQuebecقيد التجنيد
Princess Margaret Cancer Centre ( Site 0400)TorontoOntarioقيد التجنيد
North York General Hospital ( Site 0415)TorontoOntarioقيد التجنيد
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)Trois-RivièresQuebecقيد التجنيد
BC Cancer Vancouver ( Site 0404)VancouverBritish Columbiaقيد التجنيد
CancerCare Manitoba ( Site 0411)WinnipegManitobaقيد التجنيد

Colombia

المنشأةالمدينةالولاية أو المنطقةالحالة
Instituto Nacional De Cancerologia ( Site 3701)BogotáBogota D.C.قيد التجنيد
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)BogotáBogota D.C.قيد التجنيد
Clinica Somer ( Site 3704)RionegroAntioquiaقيد التجنيد
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)ValleduparCesar Departmentقيد التجنيد

Czechia

المنشأةالمدينةالولاية أو المنطقةالحالة
Masarykuv onkologicky ustav ( Site 1005)BrnoBrno-mestoقيد التجنيد
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)OlomoucOlomouc Regionقيد التجنيد
Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)PraguePraha 4قيد التجنيد

يُدرَج 261 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 17 سبتمبر 2026

    أُضيف موقع

    1 site added (311 total)

    310311

  2. 3 سبتمبر 2026

    أُضيف موقع

    1 site added (310 total)

    309310

  3. 28 أغسطس 2026

    أُضيف موقع

    1 site added (309 total)

    308309

  4. 7 أغسطس 2026

    أُضيف موقع

    1 site added (308 total)

    307308

  5. 3 أغسطس 2026

    أُضيف موقع

    1 site added (307 total)

    306307

  6. 27 يوليو 2026

    أُضيف موقع

    1 site added (306 total)

    305306

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06393374