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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06841354Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-12

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.

Arms & interventions

  • BiologicalSacituzumab tirumotecan

    IV Infusion

  • BiologicalPembrolizumab

    IV Infusion

  • DrugRescue 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).

  • DrugPaclitaxel

    IV Infusion

  • DrugNab-paclitaxel

    IV Infusion

  • DrugGemcitabine

    IV Infusion

  • DrugCarboplatin

    IV Infusion

Outcome measures

Primary

  • Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Time frame: Up to ~39 months

  • Overall Survival (OS) (sac-TMT versus TPC)

    OS is defined as the time from randomization to death due to any cause.

    Time frame: Up to ~61 months

Secondary

  • Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)

    Time frame: Up to ~61 months

  • Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)

    Time frame: Up to ~39 months

  • Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    Time frame: Up to ~39 months

  • Duration of Response (DOR)

    Time frame: Up to ~39 months

  • Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    Time frame: Baseline and up to ~61 months

  • Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    Time frame: Baseline and up to ~61 months

  • Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    Time frame: Baseline and up to ~61 months

  • Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    Time frame: Baseline and up to ~61 months

  • Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    Time frame: Baseline and up to ~61 months

  • Number of participants who experience one or more adverse events (AEs)

    Time frame: Up to ~61 months

  • Number of participants who discontinue study treatment due to an AE

    Time frame: Up to ~61 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (38)

USA Mitchell Cancer Institute ( Site 0090)

Mobile, Alabama, 36604

Recruiting
Study Coordinator · Contact

Ironwood Cancer & Research Centers ( Site 0036)

Chandler, Arizona, 85224

Recruiting
Study Coordinator · Contact

City of Hope ( Site 0097)

Duarte, California, 91010

Recruiting
Study Coordinator · Contact

City of Hope Lennar Foundation Cancer Center ( Site 0099)

Irvine, California, 92618

Recruiting
Study Coordinator · Contact

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

Los Angeles, California, 90095

Recruiting
Study Coordinator · Contact

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)

San Francisco, California, 94158

Recruiting
Study Coordinator · Contact

Yale New Haven Hospital ( Site 0001)

New Haven, Connecticut, 06520

Completed

Washington Hospital Center ( Site 0098)

Washington D.C., District of Columbia, 20010-2975

Recruiting
Study Coordinator · Contact

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

Altamonte Springs, Florida, 32701

Recruiting
Study Coordinator · Contact

Orlando Health Cancer Institute ( Site 0012)

Orlando, Florida, 32806

Recruiting
Study Coordinator · Contact

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, 33401

Recruiting
Study Coordinator · Contact

University Cancer & Blood Center, LLC ( Site 0023)

Athens, Georgia, 30607

Recruiting
Study Coordinator · Contact

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

Boise, Idaho, 83712

Recruiting
Study Coordinator · Contact

University of Illinois Cancer Center ( Site 0044)

Chicago, Illinois, 60612

Recruiting
Study Coordinator · Contact

MedStar Franklin Square Medical Center ( Site 0031)

Baltimore, Maryland, 21237

Recruiting
Study Coordinator · Contact

MedStar Good Samaritan Hospital ( Site 0079)

Baltimore, Maryland, 21239

Recruiting
Study Coordinator · Contact

MedStar Southern Maryland Hospital Center ( Site 0100)

Clinton, Maryland, 20735

Recruiting
Study Coordinator · Contact

MedStar Montgomery Medical Center ( Site 0078)

Olney, Maryland, 20832

Recruiting
Study Coordinator · Contact

Holy Cross Hospital ( Site 0091)

Silver Spring, Maryland, 20910

Recruiting
Study Coordinator · Contact

Cancer & Hematology Centers of Western Michigan ( Site 0026)

Grand Rapids, Michigan, 49503

Recruiting
Study Coordinator · Contact

Allina Health Cancer Institute ( Site 0069)

Minneapolis, Minnesota, 55407

Recruiting
Study Coordinator · Contact

Comprehensive Cancer Centers of Nevada ( Site 0015)

Las Vegas, Nevada, 89169

Recruiting
Study Coordinator · Contact

Renown Regional Medical Center ( Site 0005)

Reno, Nevada, 89502

Recruiting
Study Coordinator · Contact

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

Hackensack, New Jersey, 07601

Recruiting
Study Coordinator · Contact

New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)

Albuquerque, New Mexico, 87109

Recruiting
Study Coordinator · Contact

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

Mineola, New York, 11501

Recruiting
Study Coordinator · Contact

Laura and Isaac Perlmutter Cancer Center ( Site 0003)

New York, New York, 10016

Recruiting
Study Coordinator · Contact

Rex Hematology Oncology Associates - Garner ( Site 0071)

Garner, North Carolina, 27529

Recruiting
Study Coordinator · Contact

SCRI Oncology Partners ( Site 7004)

Nashville, Tennessee, 37203

Recruiting
Study Coordinator · Contact

Tennessee Oncology ( Site 0018)

Nashville, Tennessee, 37203

Recruiting
Study Coordinator · Contact

Texas Oncology - DFW ( Site 8007)

Dallas, Texas, 75231

Recruiting
Study Coordinator · Contact

Texas Oncology - West Texas ( Site 8004)

El Paso, Texas, 79902

Recruiting
Study Coordinator · Contact

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

Houston, Texas, 77014

Recruiting
Study Coordinator · Contact

Kelsey-Seybold Clinic ( Site 0040)

Houston, Texas, 77025

Recruiting
Study Coordinator · Contact

Texas Oncology - San Antonio ( Site 8001)

San Antonio, Texas, 78240

Recruiting
Study Coordinator · Contact

University of Utah, Huntsman Cancer Institute ( Site 0056)

Salt Lake City, Utah, 84112

Recruiting
Study Coordinator · Contact

Virginia Oncology Associates (VOA) ( Site 8002)

Norfolk, Virginia, 23502

Recruiting
Study Coordinator · Contact

Fred Hutchinson Cancer Center ( Site 0042)

Seattle, Washington, 98109

Recruiting
Study Coordinator · Contact
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) | Cancerify