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)
Recruiting · NCT06841354 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 23 US states.
- 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
- Adana Medical Park Seyhan Hastanesi ( Site 4804) - Adana, Turkey (Türkiye)
- Centro de Investigación Oncológica Galerías SC ( Site 2511) - Aguascalientes, Mexico
- Akita University Hospital ( Site 5115) - Akita, Japan
- Hacettepe Universite Hastaneleri ( Site 4800) - Ankara, Turkey (Türkiye)
- Gazi University Health Research and Application Center Gazi Hospital ( Site 4805) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi ( Site 4801) - Ankara, Turkey (Türkiye)
- Parc de Salut Mar - Hospital del Mar ( Site 4106) - Barcelona, Spain
- HELIOS Klinikum Berlin-Buch ( Site 4303) - Berlin, Germany
- Queen Elizabeth Hospital Birmingham ( Site 4017) - Birmingham, United Kingdom
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 4605) - Bologna, Italy
- Spitalul Clinic Filantropia ( Site 4703) - Bucharest, Romania
- Centrul Medical Neolife- Baneasa ( Site 4706) - Bucharest, Romania
- Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 3404) - Budapest, Hungary
- Országos Onkológiai Intézet-B-Belgyógyászati Onkológiai Osztály ( Site 3406) - Budapest, Hungary
- Velindre Cancer Centre Hospital ( Site 4008) - Cardiff, United Kingdom
- Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 2510) - Chihuahua City, Mexico
- Debreceni Egyetem Klinikai Kozpont ( Site 3411) - Debrecen, Hungary
- National Hospital Organization Kyushu Cancer Center ( Site 5119) - Fukuoka, Japan
- Fukushima Medical University Hospital ( Site 5101) - Fukushima, Japan
- Ospedale Policlinico San Martino ( Site 4606) - Genova, Italy
- Martini Ziekenhuis ( Site 4502) - Groningen, Netherlands
Showing 60 of 280 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →