A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Status: Recruiting
Location: See all (165) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent

• Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer

• Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence

• Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin

• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible

• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load

• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Locations
United States
Alabama
USA Mitchell Cancer Institute ( Site 0090)
RECRUITING
Mobile
Arizona
Ironwood Cancer & Research Centers ( Site 0036)
RECRUITING
Chandler
California
UCLA Department of Medicine - Hematology & Oncology ( Site 0047)
RECRUITING
Los Angeles
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
RECRUITING
San Francisco
Connecticut
Yale New Haven Hospital ( Site 0001)
RECRUITING
New Haven
Florida
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)
RECRUITING
Altamonte Springs
Florida Cancer Specialists - East ( Site 7000)
RECRUITING
West Palm Beach
Georgia
University Cancer & Blood Center, LLC ( Site 0023)
RECRUITING
Athens
Idaho
St. Luke's Cancer Institute: Boise ( Site 0037)
RECRUITING
Boise
Maryland
MedStar Franklin Square Medical Center ( Site 0031)
RECRUITING
Baltimore
MedStar Good Samaritan Hospital ( Site 0079)
RECRUITING
Baltimore
MedStar Montgomery Medical Center ( Site 0078)
RECRUITING
Olney
Holy Cross Hospital ( Site 0091)
RECRUITING
Silver Spring
Minnesota
Allina Health Cancer Institute ( Site 0069)
RECRUITING
Minneapolis
North Carolina
UNC REX Cancer Center ( Site 0071)
RECRUITING
Raleigh
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)
RECRUITING
Hackensack
New Mexico
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)
RECRUITING
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada ( Site 0015)
RECRUITING
Las Vegas
Renown Regional Medical Center ( Site 0005)
RECRUITING
Reno
New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center ( Site 0003)
RECRUITING
New York
Tennessee
SCRI Oncology Partners ( Site 7004)
RECRUITING
Nashville
Texas
Texas Oncology - DFW ( Site 8007)
RECRUITING
Dallas
Texas Oncology - West Texas ( Site 8004)
RECRUITING
El Paso
Texas Oncology - San Antonio ( Site 8001)
RECRUITING
San Antonio
Virginia
Virginia Oncology Associates (VOA) ( Site 8002)
RECRUITING
Norfolk
Other Locations
Argentina
Hospital Italiano de Cordoba ( Site 2406)
RECRUITING
Córdoba
Instituto Alexander Fleming ( Site 2402)
RECRUITING
Mar Del Plata
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)
RECRUITING
Mar Del Plata
Fundacion Centro Oncologico de Integración Regional ( Site 2400)
RECRUITING
Mendoza
Fundacion Estudios Clinicos ( Site 2405)
RECRUITING
Rosario
Hospital Provincial del Centenario ( Site 2410)
RECRUITING
Rosario
Clinica Viedma ( Site 2403)
RECRUITING
Viedma
Australia
Blacktown Hospital ( Site 5500)
RECRUITING
Blacktown
Rosebud Hospital ( Site 5501)
RECRUITING
Rosebud West
Belgium
ZAS Sint Augustinus ( Site 3102)
RECRUITING
Antwerp
AZ Maria Middelares ( Site 3103)
RECRUITING
Ghent
UZ Gent ( Site 3101)
RECRUITING
Ghent
Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 2307)
RECRUITING
Barretos
Liga Norte Riograndense Contra o Cancer ( Site 2310)
RECRUITING
Natal
Hospital de Câncer de Recife ( Site 2300)
RECRUITING
Recife
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)
RECRUITING
São Jose Do Rio Preto
Canada
CIUSSS- saguenay-Lac-Saint-Jean ( Site 0213)
RECRUITING
Chicoutimi
Centre Hospitalier de l'Université de Montréal ( Site 0208)
RECRUITING
Montreal
Jewish General Hospital ( Site 0203)
RECRUITING
Montreal
McGill University Health Centre ( Site 0204)
RECRUITING
Montreal
St. Marys Hospital Center ( Site 0201)
RECRUITING
Montreal
Hopital Du Saint-Sacrement ( Site 0210)
RECRUITING
Québec
North York General Hospital ( Site 0209)
RECRUITING
Toronto
Princess Margaret Cancer Centre ( Site 0202)
RECRUITING
Toronto
Chile
Biocenter ( Site 2009)
RECRUITING
Concepción
IC La Serena Research ( Site 2007)
RECRUITING
La Serena
Bradfordhill ( Site 2001)
RECRUITING
Santiago
Clínica UC San Carlos de Apoquindo ( Site 2008)
RECRUITING
Santiago
FALP ( Site 2000)
RECRUITING
Santiago
ONCOCENTRO APYS ( Site 2005)
RECRUITING
Viña Del Mar
China
The First Afflilated Hospital of Bengbu Medical College ( Site 5022)
RECRUITING
Bengbu
The First Hospital of Jilin University ( Site 5003)
RECRUITING
Changchun
Sichuan Cancer Hospital. ( Site 5018)
RECRUITING
Chengdu
Chongqing University Three Gorges Hospital ( Site 5020)
RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University ( Site 5039)
RECRUITING
Chongqing
Sun Yat-Sen University Cancer Center ( Site 5014)
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 5026)
RECRUITING
Hangzhou
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 5024)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 5012)
RECRUITING
Hangzhou
Jinan Central Hospital ( Site 5031)
RECRUITING
Jinan
Taizhou Hospital of Zhejiang Province ( Site 5029)
RECRUITING
Linhai
LinYi Cancer Hospital ( Site 5021)
RECRUITING
Linyi
Jiangsu Province Hospital ( Site 5009)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008)
RECRUITING
Nanning
The Second People's Hospital of Neijiang ( Site 5016)
RECRUITING
Neijiang
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 5006)
RECRUITING
Ürümqi
Tongji Hospital Tongji Medical Science & Technology ( Site 5007)
RECRUITING
Wuhan
The First Affiliated Hospital of Xi an Jiaotong University ( Site 5005)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University ( Site 5035)
RECRUITING
Xiamen
Xiangyang Central Hospital ( Site 5017)
RECRUITING
Xiangyang
Xuzhou Central Hospital ( Site 5036)
RECRUITING
Xuzhou
Henan Cancer Hospital ( Site 5001)
RECRUITING
Zhengzhou
Colombia
Centro Cancerologico del Caribe LTD ( Site 2209)
RECRUITING
Barranquilla
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2203)
RECRUITING
Bogotá
Instituto de Cancerología ( Site 2206)
RECRUITING
Medellín
IMAT S.A.S ( Site 2202)
RECRUITING
Montería
Oncologos Del Occidente ( Site 2208)
RECRUITING
Pereira
France
Clinique Francois Chenieux ( Site 3006)
RECRUITING
Limoges
Institut Regional du Cancer Montpellier ( Site 3009)
RECRUITING
Montpellier
Hôpital Européen Georges Pompidou ( Site 3011)
RECRUITING
Paris
Centre Henri Becquerel ( Site 3001)
RECRUITING
Rouen
Institut De Cancerologie De L Ouest ( Site 3003)
RECRUITING
Saint-herblain
HIA Sainte Anne ( Site 3007)
RECRUITING
Toulon
Israel
Rambam Health Care Campus ( Site 3700)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 3704)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 3702)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 3701)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 3703)
RECRUITING
Tel Aviv
Japan
Juntendo University Hospital ( Site 5104)
RECRUITING
Bunkyo
Fukushima Medical University Hospital ( Site 5101)
RECRUITING
Fukushima
Saitama Medical University International Medical Center ( Site 5116)
RECRUITING
Hidaka
Hiroshima City Hiroshima Citizens Hospital ( Site 5113)
RECRUITING
Hiroshima
Tokai University Hospital ( Site 5107)
RECRUITING
Isehara
Social medical corporation Hakuaikai Sagara Hospital ( Site 5114)
RECRUITING
Kagoshima
Cancer Institute Hospital of JFCR ( Site 5102)
RECRUITING
Koto
Kyoto University Hospital ( Site 5110)
RECRUITING
Kyoto
Nagoya City University Hospital ( Site 5108)
RECRUITING
Nagoya
Okayama University Hospital ( Site 5118)
RECRUITING
Okayama
Osaka International Cancer Institute ( Site 5112)
RECRUITING
Osaka
Hokkaido University Hospital ( Site 5100)
RECRUITING
Sapporo
Showa Medical University Hospital ( Site 5103)
RECRUITING
Shinagawa
National Center for Global Health and Medicine ( Site 5105)
RECRUITING
Shinjuku
The University of Osaka Hospital ( Site 5111)
RECRUITING
Suita
Mie University Hospital ( Site 5109)
RECRUITING
Tsu
Kanagawa Cancer Center ( Site 5106)
RECRUITING
Yokohama
Malaysia
Pantai Hospital Kuala Lumpur ( Site 5402)
RECRUITING
Kuala Lumpur
University Malaya Medical Centre ( Site 5403)
RECRUITING
Kuala Lumpur
Sarawak General Hospital ( Site 5400)
RECRUITING
Kuching
National Cancer Institute ( Site 5401)
RECRUITING
Putrajaya
Netherlands
Meander Medisch Centrum ( Site 4500)
RECRUITING
Amersfoort
Ziekenhuis Rijnstate ( Site 4501)
RECRUITING
Arnhem
Deventer Ziekenhuis ( Site 4503)
RECRUITING
Deventer
ETZ Elisabeth ( Site 4504)
RECRUITING
Tilburg
New Zealand
Harbour Cancer & Wellness ( Site 5600)
RECRUITING
Newmarket
Bowen Hospital ( Site 5601)
RECRUITING
Wellington
Peru
Clínica Internacional - Sede San Borja ( Site 2604)
RECRUITING
Lima
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 2603)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2601)
RECRUITING
Lima
Oncosalud ( Site 2600)
RECRUITING
Lima
Poland
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 3802)
RECRUITING
Bydgoszcz
Szpitale Pomorskie Sp. z o. o. ( Site 3805)
RECRUITING
Gdynia
Szpital Wojewodzki im.M.Kopernika. ( Site 3800)
RECRUITING
Koszalin
Pratia MCM Krakow ( Site 3812)
RECRUITING
Krakow
Wielkopolskie Centrum Onkologii-Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dzien ( Site 3811)
RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3801)
RECRUITING
Siedlce
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 3803)
RECRUITING
Warsaw
Mazowiecki Szpital Onkologiczny ( Site 3807)
RECRUITING
Wieliszew
Republic of Korea
Kyungpook National University Chilgok Hospital ( Site 5205)
RECRUITING
Daegu
National Cancer Center ( Site 5202)
RECRUITING
Goyang-si
Seoul National University Bundang Hospital ( Site 5204)
RECRUITING
Seongnam
Samsung Medical Center ( Site 5203)
RECRUITING
Seoul
Seoul National University Hospital ( Site 5200)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 5201)
RECRUITING
Seoul
Romania
Centrul Medical Neolife- Baneasa ( Site 4706)
RECRUITING
Bucharest
Spitalul Clinic Filantropia ( Site 4703)
RECRUITING
Bucharest
Institutul Oncologic Cluj ( Site 4701)
RECRUITING
Cluj-napoca
S.C. Radiotherapy Center Cluj S.R.L ( Site 4705)
RECRUITING
Comuna Floresti
Centrul de Oncologie Sfântul Nectarie ( Site 4702)
RECRUITING
Craiova
Spitalul Municipal Schuller Ploiești ( Site 4707)
RECRUITING
Ploieşti
Cabinet Medical Oncomed ( Site 4704)
RECRUITING
Timișoara
Spain
Parc de Salut Mar - Hospital del Mar ( Site 4106)
RECRUITING
Barcelona
ICO L Hospitalet ( Site 4101)
RECRUITING
L'hospitalet De Llobregat
Hospital Beata María Ana ( Site 4105)
RECRUITING
Madrid
Hospital Clinico San Carlos ( Site 4100)
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal ( Site 4103)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 4104)
RECRUITING
Seville
Hospital General Universitario de Valencia ( Site 4102)
RECRUITING
Valencia
Taiwan
Taichung Veterans General Hospital ( Site 5303)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 5304)
RECRUITING
Tainan City
Mackay Memorial Hospital ( Site 5301)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 5300)
RECRUITING
Taipei
Chang Gung Memorial Hospital ( Site 5302)
RECRUITING
Taoyuan District
Thailand
Faculty of Medicine Siriraj Hospital ( Site 5800)
RECRUITING
Bangkoknoi
Songklanagarind hospital ( Site 5801)
RECRUITING
Hat Yai
Faculty of Medicine - Khon Kaen University ( Site 5802)
RECRUITING
Khon Kaen
United Kingdom
St Bartholomew's Hospital ( Site 4001)
RECRUITING
London
University College London Hospital ( Site 4007)
RECRUITING
London
Nottingham University Hospital NHS Trust ( Site 4009)
RECRUITING
Nottingham
Royal Cornwall Hospital ( Site 4003)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-03-16
Estimated Completion Date: 2030-05-18
Participants
Target number of participants: 1000
Treatments
Experimental: Arm A: Sacituzumab Tirumotecan
Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation.
Experimental: Arm B: Sacituzumab Tirumotecan + Pembrolizumab
Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to \~2 years).
Active_comparator: Arm C: Treatment of Physician's Choice (TPC)
Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m\^2 once every week (Q1W) OR paclitaxel IV 90 mg/m\^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m\^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m\^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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