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Clinical Trials in the UK / NCT06841354
Recruiting Phase 3

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)

NCT06841354 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2025-03-16
Last updated
2026-09-11

Condition(s) studied

Triple Negative Breast Neoplasms

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecanPembrolizumabRescue MedicationPaclitaxelNab-paclitaxelGemcitabineCarboplatin

Sacituzumab tirumotecan: IV Infusion

Pembrolizumab: IV Infusion

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).

Paclitaxel: IV Infusion

Nab-paclitaxel: IV Infusion

Gemcitabine: IV Infusion

Carboplatin: IV Infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (280)

FacilityCityRegionStatus
USA Mitchell Cancer Institute ( Site 0090) Mobile Alabama Recruiting
Ironwood Cancer & Research Centers ( Site 0036) Chandler Arizona Recruiting
City of Hope ( Site 0097) Duarte California Recruiting
City of Hope Lennar Foundation Cancer Center ( Site 0099) Irvine California Recruiting
UCLA Department of Medicine - Hematology & Oncology ( Site 0047) Los Angeles California Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016) San Francisco California Recruiting
Yale New Haven Hospital ( Site 0001) New Haven Connecticut Completed
Washington Hospital Center ( Site 0098) Washington D.C. District of Columbia Recruiting
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007) Altamonte Springs Florida Recruiting
Orlando Health Cancer Institute ( Site 0012) Orlando Florida Recruiting
Florida Cancer Specialists - East ( Site 7000) West Palm Beach Florida Recruiting
University Cancer & Blood Center, LLC ( Site 0023) Athens Georgia Recruiting
St. Luke's Cancer Institute: Boise ( Site 0037) Boise Idaho Recruiting
University of Illinois Cancer Center ( Site 0044) Chicago Illinois Recruiting
MedStar Franklin Square Medical Center ( Site 0031) Baltimore Maryland Recruiting
MedStar Good Samaritan Hospital ( Site 0079) Baltimore Maryland Recruiting
MedStar Southern Maryland Hospital Center ( Site 0100) Clinton Maryland Recruiting
MedStar Montgomery Medical Center ( Site 0078) Olney Maryland Recruiting
Holy Cross Hospital ( Site 0091) Silver Spring Maryland Recruiting
Cancer & Hematology Centers of Western Michigan ( Site 0026) Grand Rapids Michigan Recruiting
Allina Health Cancer Institute ( Site 0069) Minneapolis Minnesota Recruiting
Hattiesburg Clinic Hematology/Oncology ( Site 0104) Hattiesburg Mississippi Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0015) Las Vegas Nevada Recruiting
Renown Regional Medical Center ( Site 0005) Reno Nevada Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082) Hackensack New Jersey Recruiting
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019) Albuquerque New Mexico Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073) Mineola New York Recruiting
Laura and Isaac Perlmutter Cancer Center ( Site 0003) New York New York Recruiting
Rex Hematology Oncology Associates - Garner ( Site 0071) Garner North Carolina Completed
SCRI Oncology Partners ( Site 7004) Nashville Tennessee Recruiting
Tennessee Oncology ( Site 0018) Nashville Tennessee Recruiting
Texas Oncology - DFW ( Site 8007) Dallas Texas Recruiting
Texas Oncology - West Texas ( Site 8004) El Paso Texas Recruiting
Kelsey-Seybold Clinic - North Houston Campus ( Site 0096) Houston Texas Recruiting
Kelsey-Seybold Clinic ( Site 0040) Houston Texas Recruiting
Texas Oncology - San Antonio ( Site 8001) San Antonio Texas Recruiting
University of Utah, Huntsman Cancer Institute ( Site 0056) Salt Lake City Utah Recruiting
Virginia Oncology Associates (VOA) ( Site 8002) Norfolk Virginia Recruiting
Fred Hutchinson Cancer Center ( Site 0042) Seattle Washington Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401) Mar del Plata Buenos Aires Recruiting

+ 240 more sites — see the full list on the official registry below.

On this site

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More Merck Sharp & Dohme LLC trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06841354 on ClinicalTrials.gov ↗ ← All trials in the UK