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

Status: Recruiting
Location: See all (166) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 12 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

Locations
United States
Alabama
Infirmary Cancer Care ( Site 0001)
RECRUITING
Mobile
Arizona
Ironwood Cancer & Research Centers-Research ( Site 0054)
RECRUITING
Chandler
California
Cancer Blood and Specialty Clinic-Research ( Site 0008)
RECRUITING
Los Alamitos
Bass Medical Group ( Site 0089)
RECRUITING
Walnut Creek
Georgia
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
RECRUITING
Thomasville
Illinois
Orchard Healthcare Research Inc. ( Site 0014)
RECRUITING
Skokie
Indiana
Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
RECRUITING
Fort Wayne
Kansas
Cancer Center of Kansas ( Site 0004)
RECRUITING
Wichita
Louisiana
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
RECRUITING
Monroe
Louisiana State University Health Sciences Shreveport ( Site 0029)
RECRUITING
Shreveport
Michigan
Profound Research LLC ( Site 0074)
RECRUITING
Royal Oak
Missouri
Lake Regional Hospital ( Site 0009)
RECRUITING
Osage Beach
Ohio
Cleveland Clinic - Mercy Hospital ( Site 0057)
RECRUITING
Canton
Genesis Healthcare System ( Site 0025)
RECRUITING
Zanesville
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
RECRUITING
Tulsa
Pennsylvania
Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
RECRUITING
Philadelphia
Tennessee
Nashville General Hospital ( Site 0072)
RECRUITING
Nashville
Texas
Harrington Cancer Center ( Site 0061)
RECRUITING
Amarillo
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (
RECRUITING
Tyler
Virginia
Virginia Cancer Institute ( Site 0034)
RECRUITING
Richmond
Other Locations
Argentina
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC) ( Site 0508)
RECRUITING
Buenos Aires
Hospital Aleman-Oncology ( Site 0501)
RECRUITING
Buenos Aires
Instituto de Oncología Angel H. Roffo ( Site 0503)
RECRUITING
Buenos Aires
Sanatorio Finochietto ( Site 0513)
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires-Oncology ( Site 0502)
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto Alexander Fleming-Alexander Fleming ( Site 0509)
RECRUITING
Ciudad Autónoma De Buenos Aires
Sanatorio Parque ( Site 0512)
RECRUITING
Rosario
Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
RECRUITING
Brisbane
Frankston Hospital-Oncology and Haematology ( Site 2704)
RECRUITING
Frankston
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)
RECRUITING
Macquarie University
Westmead Hospital-Westmead Breast Cancer Institute ( Site 2700)
RECRUITING
Westmead
Austria
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)
RECRUITING
Linz
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis
RECRUITING
Salzburg
Klinikum Wels-Grieskirchen GmbH ( Site 1205)
RECRUITING
Wels
Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)
RECRUITING
Brussels
AZ Maria Middelares-IKG ( Site 0903)
RECRUITING
Gent
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)
RECRUITING
Namur
Brazil
PRONUTRIR-CLINICAL RESEARCH ( Site 0609)
RECRUITING
Fortaleza
Hospital do Câncer Mãe de Deus ( Site 0604)
RECRUITING
Porto Alegre
Instituto de Oncologia Saint Gallen ( Site 0614)
RECRUITING
Santa Cruz Do Sul
IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)
RECRUITING
Sao Paulo
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)
RECRUITING
Taubaté
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)
RECRUITING
Teresina
Canada
The Moncton Hospital ( Site 0401)
RECRUITING
Moncton
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)
RECRUITING
Montreal
Jewish General Hospital ( Site 0416)
RECRUITING
Montreal
The Ottawa Hospital - General Campus ( Site 0414)
RECRUITING
Ottawa
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski (
RECRUITING
Rimouski
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (
RECRUITING
Trois-rivières
BC Cancer Vancouver ( Site 0404)
RECRUITING
Vancouver
CancerCare Manitoba ( Site 0411)
RECRUITING
Winnipeg
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)
RECRUITING
Helsinki
Tampereen yliopistollinen sairaala ( Site 1102)
RECRUITING
Tampere
Turku University Hospital-Department of Oncology ( Site 1103)
RECRUITING
Turku
France
Institut de Cancérologie de l'Ouest ( Site 1316)
RECRUITING
Angers Cedex 02
Centre Hospitalier de la Côte Basque ( Site 1315)
RECRUITING
Bayonne
CHU Besançon ( Site 1311)
RECRUITING
Besançon
Clinique Tivoli Ducos ( Site 1322)
RECRUITING
Bordeaux
CHRU Brest - Hopital Cavale Blanche ( Site 1304)
RECRUITING
Brest
Centre François Baclesse ( Site 1318)
RECRUITING
Caen
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)
RECRUITING
Clermont-ferrand
Centre Georges François Leclerc ( Site 1312)
RECRUITING
Dijon
Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)
RECRUITING
Levallois-perret
CENTRE LEON BERARD ( Site 1300)
RECRUITING
Lyon Cedex08
Institut Paoli-Calmettes ( Site 1309)
RECRUITING
Marseille
Centre Antoine-Lacassagne ( Site 1308)
RECRUITING
Nice
Hôpital Tenon ( Site 1303)
RECRUITING
Paris
Centre Hospitalier de Pau ( Site 1302)
RECRUITING
Pau
Institut de Cancérologie de l'Ouest ( Site 1305)
RECRUITING
Saint Herblain
Hôpital Privé Drôme-Ardèche ( Site 1301)
RECRUITING
Valence
Centre de Cancerologie Les Dentellieres ( Site 1306)
RECRUITING
Valenciennes
Germany
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)
RECRUITING
Berlin
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)
RECRUITING
Erlangen
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)
RECRUITING
Essen
Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)
RECRUITING
Ludwigsburg
Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)
RECRUITING
Mönchengladbach
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)
RECRUITING
Muenchen
Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)
RECRUITING
Potsdam
CaritasKlinikum Saarbrücken St. Theresia ( Site 1410)
RECRUITING
Saarbrücken
Greece
Aretaieio Hospital Oncology Unit ( Site 1505)
RECRUITING
Athens
Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)
RECRUITING
Athens
University General Hospital of Larissa ( Site 1503)
RECRUITING
Larissa
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)
RECRUITING
Patras
Agios Loukas Clinic ( Site 1507)
RECRUITING
Thessaloniki
Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 1502)
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 3600)
RECRUITING
Hong Kong
Hong Kong United Oncology Centre ( Site 3601)
RECRUITING
Kowloon
Ireland
Bon Secours Cork Hospital ( Site 1600)
RECRUITING
Cork
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)
RECRUITING
Dublin
Israel
Soroka Medical Center-Oncology ( Site 1704)
RECRUITING
Beer Sheva
Hadassah Medical Center ( Site 1700)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1702)
RECRUITING
Petah Tikva
Sheba Medical Center-ONCOLOGY ( Site 1701)
RECRUITING
Ramat Gan
Italy
CRO-IRCCS ( Site 1808)
RECRUITING
Aviano
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)
RECRUITING
Brescia
Azienda Ospedaliera Universitaria Careggi ( Site 1805)
RECRUITING
Firenze
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)
RECRUITING
Milano
Humanitas Istituto Clinico Catanese ( Site 1811)
RECRUITING
Misterbianco
Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)
RECRUITING
Monza
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)
RECRUITING
Naples
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia
RECRUITING
Napoli
Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)
RECRUITING
Novara
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
RECRUITING
Roma
Japan
Juntendo University Hospital ( Site 3408)
RECRUITING
Bunkyo
Fukushima Medical University Hospital ( Site 3401)
RECRUITING
Fukushima
Gifu University Hospital ( Site 3426)
RECRUITING
Gifu
Hiroshima City Hiroshima Citizens Hospital ( Site 3418)
RECRUITING
Hiroshima
Tokai University Hospital ( Site 3413)
RECRUITING
Isehara
Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)
RECRUITING
Kagoshima
Kumamoto University Hospital ( Site 3420)
RECRUITING
Kumamoto
Kyoto University Hospital ( Site 3415)
RECRUITING
Kyoto
Kitasato University Hospital ( Site 3411)
RECRUITING
Sagamihara
Hokkaido University Hospital ( Site 3400)
RECRUITING
Sapporo
Showa University Hospital ( Site 3406)
RECRUITING
Shinagawa
Tokyo Medical University Hospital ( Site 3407)
RECRUITING
Shinjuku
Osaka University Hospital ( Site 3416)
RECRUITING
Suita
Mie University Hospital ( Site 3423)
RECRUITING
Tsu
Kanagawa Cancer Center ( Site 3412)
RECRUITING
Yokohama
Malaysia
Pantai Hospital Kuala Lumpur ( Site 2801)
RECRUITING
Kuala Lumpur
Prince Court Medical Centre ( Site 2802)
RECRUITING
Kuala Lumpur
Norway
Drammen Sykehus, Vestre Viken HF ( Site 2001)
RECRUITING
Drammen
Oslo universitetssykehus, Radiumhospitalet ( Site 2002)
RECRUITING
Oslo
Stavanger Universitetssykehus ( Site 2004)
RECRUITING
Stavanger
Poland
Bialostockie Centrum Onkologii ( Site 2105)
RECRUITING
Bialystok
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)
RECRUITING
Bydgoszcz
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)
RECRUITING
Gdynia
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Sit
RECRUITING
Gliwice
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
RECRUITING
Kielce
Zachodniopomorskie Centrum Onkologii ( Site 2108)
RECRUITING
Szczecin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (
RECRUITING
Warszawa
Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)
RECRUITING
Wieliszew
Portugal
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)
RECRUITING
Amadora
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)
RECRUITING
Lisbon
Instituto Portugues de Oncologia do Porto ( Site 2202)
RECRUITING
Porto
Republic of Korea
Asan Medical Center-Department of Oncology ( Site 3103)
RECRUITING
Seoul
Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Si
RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)
RECRUITING
Seoul
Seoul National University Hospital-Internal Medicine ( Site 3102)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore-Medical Oncology ( Site 3002)
RECRUITING
Singapore
Spain
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)
RECRUITING
A Coruña
Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)
RECRUITING
L Hospitalet De Llobregat
Hospital Beata María Ana-oncology ( Site 2309)
RECRUITING
Madrid
Hospital Clinico San Carlos-Oncology Department ( Site 2306)
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)
RECRUITING
Majadahonda
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)
RECRUITING
Sevilla
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)
RECRUITING
Valencia
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)
RECRUITING
Valencia
Switzerland
Kantonsspital Graubünden-Medizin ( Site 2404)
RECRUITING
Chur
HFR Fribourg - Hôpital Cantonal ( Site 2402)
RECRUITING
Fribourg
Clinique Générale-Beaulieu ( Site 2406)
RECRUITING
Geneva
Spital Thun ( Site 2400)
RECRUITING
Thun
Brust-Zentrum ( Site 2401)
RECRUITING
Zürich
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)
RECRUITING
Adana
Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)
RECRUITING
Ankara
Samsun Medical Park Hastanesi-medical oncology ( Site 2500)
RECRUITING
Samsun
United Kingdom
University Hospitals Bristol NHS Foundation Trust ( Site 2601)
RECRUITING
Bristol
Western General Hospital ( Site 2607)
RECRUITING
Edinburgh
St James's University Hospital-Leeds Cancer Centre ( Site 2608)
RECRUITING
Leeds
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
RECRUITING
London
University College London Hospital ( Site 2604)
RECRUITING
London
The Royal Cornwall Hospital ( Site 2603)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2037-12-14
Participants
Target number of participants: 1530
Treatments
Experimental: Pembrolizumab + sacituzumab tirumotecan
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.
Active_comparator: Treatment of Physician's Choice
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.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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