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RECRUITING

NCT06841354

PHASE3

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-03-16

Completion Date

2030-05-18

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Triple Negative Breast Neoplasms

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

IV Infusion

BIOLOGICAL

Pembrolizumab

IV Infusion

DRUG

Rescue Medication

Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

DRUG

Paclitaxel

IV Infusion

DRUG

Nab-paclitaxel

IV Infusion

DRUG

Gemcitabine

IV Infusion

DRUG

Carboplatin

IV Infusion

Inclusion Criteria: 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 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has breast cancer amenable to treatment with curative intent * Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10 * Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer * Has Grade ≥2 peripheral neuropathy * Has 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 * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has skin only metastatic disease * Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications * Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection * History of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

Locations (283)

USA Mitchell Cancer Institute ( Site 0090)

Mobile, Alabama, United States

Ironwood Cancer & Research Centers ( Site 0036)

Chandler, Arizona, United States

City of Hope ( Site 0097)

Duarte, California, United States

City of Hope Lennar Foundation Cancer Center ( Site 0099)

Irvine, California, United States

UCLA Department of Medicine - Hematology & Oncology ( Site 0047)

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)

San Francisco, California, United States

Yale New Haven Hospital ( Site 0001)

New Haven, Connecticut, United States

Washington Hospital Center ( Site 0098)

Washington D.C., District of Columbia, United States

AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)

Altamonte Springs, Florida, United States

Orlando Health Cancer Institute ( Site 0012)

Orlando, Florida, United States

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, United States

University Cancer & Blood Center, LLC ( Site 0023)

Athens, Georgia, United States

St. Luke's Cancer Institute: Boise ( Site 0037)

Boise, Idaho, United States

University of Illinois Cancer Center ( Site 0044)

Chicago, Illinois, United States

MedStar Franklin Square Medical Center ( Site 0031)

Baltimore, Maryland, United States

MedStar Good Samaritan Hospital ( Site 0079)

Baltimore, Maryland, United States

MedStar Southern Maryland Hospital Center ( Site 0100)

Clinton, Maryland, United States

MedStar Montgomery Medical Center ( Site 0078)

Olney, Maryland, United States

Holy Cross Hospital ( Site 0091)

Silver Spring, Maryland, United States

Cancer & Hematology Centers of Western Michigan ( Site 0026)

Grand Rapids, Michigan, United States

Allina Health Cancer Institute ( Site 0069)

Minneapolis, Minnesota, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0104)

Hattiesburg, Mississippi, United States

Comprehensive Cancer Centers of Nevada ( Site 0015)

Las Vegas, Nevada, United States

Renown Regional Medical Center ( Site 0005)

Reno, Nevada, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)

Hackensack, New Jersey, United States

New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)

Albuquerque, New Mexico, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center ( Site 0003)

New York, New York, United States

Rex Hematology Oncology Associates - Garner ( Site 0071)

Garner, North Carolina, United States

SCRI Oncology Partners ( Site 7004)

Nashville, Tennessee, United States

Tennessee Oncology ( Site 0018)

Nashville, Tennessee, United States

Texas Oncology - DFW ( Site 8007)

Dallas, Texas, United States

Texas Oncology - West Texas ( Site 8004)

El Paso, Texas, United States

Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)

Houston, Texas, United States

Kelsey-Seybold Clinic ( Site 0040)

Houston, Texas, United States

Texas Oncology - San Antonio ( Site 8001)

San Antonio, Texas, United States

University of Utah, Huntsman Cancer Institute ( Site 0056)

Salt Lake City, Utah, United States

Virginia Oncology Associates (VOA) ( Site 8002)

Norfolk, Virginia, United States

Fred Hutchinson Cancer Center ( Site 0042)

Seattle, Washington, United States

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)

Mar del Plata, Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 2402)

Mar del Plata, Buenos Aires, Argentina

Hospital Italiano de Cordoba ( Site 2406)

Córdoba, Córdoba Province, Argentina

Clinica Viedma ( Site 2403)

Viedma, Río Negro Province, Argentina

Fundacion Estudios Clinicos ( Site 2405)

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario ( Site 2410)

Rosario, Santa Fe Province, Argentina

Fundacion Centro Oncologico de Integración Regional ( Site 2400)

Mendoza, Argentina

Blacktown Hospital ( Site 5500)

Blacktown, New South Wales, Australia

Peninsula Health Frankston Hospital ( Site 5501)

Frankston, Victoria, Australia

ZAS Sint Augustinus ( Site 3102)

Antwerp, Flanders, Belgium

Ziekenhuis Oost Limburg ( Site 3105)

Genk, Limburg, Belgium

AZ Maria Middelares ( Site 3103)

Ghent, Oost-Vlaanderen, Belgium

UZ Gent ( Site 3101)

Ghent, Oost-Vlaanderen, Belgium

Hospital de Câncer de Recife ( Site 2300)

Recife, Pernambuco, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 2310)

Natal, Rio Grande do Norte, Brazil

Hospital Nossa Senhora da Conceição ( Site 2302)

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 2307)

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)

São Jose Do Rio Preto, São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 2306)

São Paulo, Brazil

Cross Cancer Institute ( Site 0216)

Edmonton, Alberta, Canada

Lakeridge Health ( Site 0217)

Oshawa, Ontario, Canada

North York General Hospital ( Site 0209)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0202)

Toronto, Ontario, Canada

CIUSSS- saguenay-Lac-Saint-Jean ( Site 0213)

Chicoutimi, Quebec, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0208)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0203)

Montreal, Quebec, Canada

St. Marys Hospital Center ( Site 0201)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0204)

Montreal, Quebec, Canada

Hopital Du Saint-Sacrement ( Site 0210)

Québec, Quebec, Canada

Saskatoon Cancer Centre ( Site 0215)

Saskatoon, Saskatchewan, Canada

Biocenter ( Site 2009)

Concepción, Biobio, Chile

IC La Serena Research ( Site 2007)

La Serena, Coquimbo Region, Chile

Fundación Arturo López Pérez ( Site 2000)

Santiago, Region M. de Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 2008)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 2001)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS ( Site 2005)

Viña del Mar, Valparaiso, Chile

The First Afflilated Hospital of Bengbu Medical College ( Site 5022)

Bengbu, Anhui, China

The First Affiliated Hospital of Chongqing Medical University ( Site 5039)

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital ( Site 5020)

Chongqing, Chongqing Municipality, China

The First Affiliated hospital of Xiamen University ( Site 5035)

Xiamen, Fujian, China

Sun Yat-Sen University Cancer Center ( Site 5014)

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008)

Nanning, Guangxi, China

Henan Cancer Hospital ( Site 5001)

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical Science & Technology ( Site 5007)

Wuhan, Hubei, China

Xiangyang Central Hospital ( Site 5017)

Xiangyang, Hubei, China

Hunan Cancer Hospital ( Site 5002)

Changsha, Hunan, China

Jiangsu Province Hospital ( Site 5009)

Nanjing, Jiangsu, China

Xuzhou Central Hospital ( Site 5036)

Xuzhou, Jiangsu, China

Jilin Province Tumor Hospital ( Site 5040)

Changchun, Jilin, China

The First Hospital of Jilin University ( Site 5003)

Changchun, Jilin, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 5005)

Xi'an, Shaanxi, China

Jinan Central Hospital ( Site 5031)

Jinan, Shandong, China

LinYi Cancer Hospital ( Site 5021)

Linyi, Shandong, China

Shanxi Cancer Hospital ( Site 5043)

Taiyuan, Shanxi, China

Sichuan Cancer Hospital. ( Site 5018)

Chengdu, Sichuan, China

The Second People's Hospital of Neijiang ( Site 5016)

Neijiang, Sichuan, China

Affiliated Tumor Hospital of Xinjiang Medical University ( Site 5006)

Ürümqi, Xinjiang, China

The First Affiliated Hospital Zhejiang University School of Medicine ( Site 5026)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 5012)

Hangzhou, Zhejiang, China

The Second Affiliated hospital of Zhejiang University school of medicine ( Site 5024)

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province ( Site 5029)

Linhai, Zhejiang, China

And 183 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (283)