Recruiting

Phase 3

Sac-TMT & PembrolizumabA 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

Code:

NCT06841354

Conditions

Triple Negative Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Pembrolizumab

Rescue Medication

Paclitaxel

Nab-paclitaxel

Study Details

Brief 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.

Conditions

Triple Negative Breast Neoplasms

Study ID

NCT06841354

Start date

Mar 16, 2025

Status verified date

Sep, 2026

Completion date

May 18, 2030

Anticipated

Primary completion date

May 18, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC) [ Time Frame: Up to ~39 months ]
Overall Survival (OS) (sac-TMT versus TPC) [ Time Frame: Up to ~61 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

USA Mitchell Cancer Institute ( Site 0090)

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Study Coordinator

251-410-4924

Ironwood Cancer & Research Centers ( Site 0036)

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Study Coordinator

623-312-3000

City of Hope ( Site 0097)

Recruiting

Duarte, California, United States, 91010

Contacts

Study Coordinator

626-218-9845

City of Hope Lennar Foundation Cancer Center ( Site 0099)

Recruiting

Irvine, California, United States, 92618

Contacts

Study Coordinator

626-218-0720

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

650-283-5067

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

415-353-7070

Washington Hospital Center ( Site 0098)

Recruiting

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

Contacts

Study Coordinator

202-877-8839

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

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Study Coordinator

407-303-2284

Orlando Health Cancer Institute ( Site 0012)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

321-841-8284

Florida Cancer Specialists - East ( Site 7000)

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Study Coordinator

561-366-4100

University Cancer & Blood Center, LLC ( Site 0023)

Recruiting

Athens, Georgia, United States, 30607

Contacts

Study Coordinator

706-353-2990

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

Recruiting

Boise, Idaho, United States, 83712

Contacts

Study Coordinator

208-381-2711

University of Illinois Cancer Center ( Site 0044)

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Study Coordinator

312-996-1581

MedStar Franklin Square Medical Center ( Site 0031)

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Study Coordinator

443-777-7147

MedStar Good Samaritan Hospital ( Site 0079)

Recruiting

Baltimore, Maryland, United States, 21239

Contacts

Study Coordinator

443-777-7147

MedStar Southern Maryland Hospital Center ( Site 0100)

Recruiting

Clinton, Maryland, United States, 20735

Contacts

Study Coordinator

301-877-4673

MedStar Montgomery Medical Center ( Site 0078)

Recruiting

Olney, Maryland, United States, 20832

Contacts

Study Coordinator

301-774-8882

Holy Cross Hospital ( Site 0091)

Recruiting

Silver Spring, Maryland, United States, 20910

Contacts

Study Coordinator

301-754-7552

Cancer & Hematology Centers of Western Michigan ( Site 0026)

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-954-9800

Allina Health Cancer Institute ( Site 0069)

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Study Coordinator

763-577-7000

Hattiesburg Clinic Hematology/Oncology ( Site 0104)

Recruiting

Hattiesburg, Mississippi, United States, 39401

Contacts

Study Coordinator

601-261-1700

Comprehensive Cancer Centers of Nevada ( Site 0015)

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Study Coordinator

702-952-3350

Renown Regional Medical Center ( Site 0005)

Recruiting

Reno, Nevada, United States, 89502

Contacts

Study Coordinator

775-982-5050

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5900

New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Study Coordinator

505-842-8171

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

Recruiting

Mineola, New York, United States, 11501

Contacts

Study Coordinator

516-663-9500

Laura and Isaac Perlmutter Cancer Center ( Site 0003)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

212-731-6126

SCRI Oncology Partners ( Site 7004)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7274

Tennessee Oncology ( Site 0018)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

877-836-6662

Texas Oncology - DFW ( Site 8007)

Recruiting

Dallas, Texas, United States, 75231

Contacts

Study Coordinator

214-739-4175

Texas Oncology - West Texas ( Site 8004)

Recruiting

El Paso, Texas, United States, 79902

Contacts

Study Coordinator

915-747-4835

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

Recruiting

Houston, Texas, United States, 77014

Contacts

Study Coordinator

713-239-4510

Kelsey-Seybold Clinic ( Site 0040)

Recruiting

Houston, Texas, United States, 77025

Contacts

Study Coordinator

713-239-4510

Texas Oncology - San Antonio ( Site 8001)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-419-2608

University of Utah, Huntsman Cancer Institute ( Site 0056)

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Study Coordinator

801-587-7000

Virginia Oncology Associates (VOA) ( Site 8002)

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Study Coordinator

757-368-5033

Fred Hutchinson Cancer Center ( Site 0042)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-606-6329

Cross Cancer Institute ( Site 0216)

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Study Coordinator

7804328644

Lakeridge Health ( Site 0217)

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Study Coordinator

905-576-8711

North York General Hospital ( Site 0209)

Recruiting

Toronto, Ontario, Canada, M2K 1E1

Contacts

Study Coordinator

416-756-6000

Princess Margaret Cancer Centre ( Site 0202)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-2000

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

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

Contacts

Study Coordinator

418-541-1000

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

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Study Coordinator

514-890-8444

Jewish General Hospital ( Site 0203)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

St. Marys Hospital Center ( Site 0201)

Recruiting

Montreal, Quebec, Canada, H3T 1M5

Contacts

Study Coordinator

514-891-6904

McGill University Health Centre ( Site 0204)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

514-299-6425

Hopital Du Saint-Sacrement ( Site 0210)

Recruiting

Québec, Quebec, Canada, G1S 4L8

Contacts

Study Coordinator

4186827511

Saskatoon Cancer Centre ( Site 0215)

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Study Coordinator

306-655-2662

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Antibody-drug conjugate (ADC)
Trophoblast cell-surface antigen 2 (TROP2)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.