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
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2025-03-16
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Number of sites
271
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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.
clinicaltrials.gov
Short title
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)
clinicaltrials.gov
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-05-18
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First posted
2025-02-24
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Registry last updated
2026-08-28
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Primary completion date
2030-05-18
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Start date
2025-03-16
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
2
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Number of sites
271
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06841354
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ClinicalTrials.gov ID
NCT06841354
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: Up to ~39 months

    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.

  2. Overall Survival (OS) (sac-TMT versus TPC)

    Timeframe: Up to ~61 months

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

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

    Timeframe: Up to ~61 months

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

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

    Timeframe: Up to ~39 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on 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.

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

    Timeframe: Up to ~39 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on BICR.

  4. Duration of Response (DOR)

    Timeframe: Up to ~39 months

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on BICR, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD.

  5. 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)

    Timeframe: Baseline and up to ~61 months

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

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

    Timeframe: Baseline and up to ~61 months

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

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

    Timeframe: Baseline and up to ~61 months

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning.

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

    Timeframe: Baseline and up to ~61 months

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.

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

    Timeframe: Baseline and up to ~61 months

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Have you had diarrhea?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.

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

    Timeframe: Up to ~61 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  11. Number of participants who discontinue study treatment due to an AE

    Timeframe: Up to ~61 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

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
Sources for eligibility
clinicaltrials.gov

  • USA Mitchell Cancer Institute ( Site 0090)Mobile, United StatesRecruiting
  • Ironwood Cancer & Research Centers ( Site 0036)Chandler, United StatesRecruiting
  • City of Hope ( Site 0097)Duarte, United StatesRecruiting
  • City of Hope Lennar Foundation Cancer Center ( Site 0099)Irvine, United StatesRecruiting
  • UCLA Department of Medicine - Hematology & Oncology ( Site 0047)Los Angeles, United StatesRecruiting
  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)San Francisco, United StatesRecruiting
  • Yale New Haven Hospital ( Site 0001)New Haven, United StatesCompleted
  • Washington Hospital Center ( Site 0098)Washington D.C., United StatesRecruiting
  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)Altamonte Springs, United StatesRecruiting
  • Orlando Health Cancer Institute ( Site 0012)Orlando, United StatesRecruiting
  • Florida Cancer Specialists - East ( Site 7000)West Palm Beach, United StatesRecruiting
  • University Cancer & Blood Center, LLC ( Site 0023)Athens, United StatesRecruiting
  • St. Luke's Cancer Institute: Boise ( Site 0037)Boise, United StatesRecruiting
  • University of Illinois Cancer Center ( Site 0044)Chicago, United StatesRecruiting
  • MedStar Franklin Square Medical Center ( Site 0031)Baltimore, United StatesRecruiting
  • MedStar Good Samaritan Hospital ( Site 0079)Baltimore, United StatesRecruiting
  • MedStar Southern Maryland Hospital Center ( Site 0100)Clinton, United StatesRecruiting
  • MedStar Montgomery Medical Center ( Site 0078)Olney, United StatesRecruiting
  • Holy Cross Hospital ( Site 0091)Silver Spring, United StatesRecruiting
  • Cancer & Hematology Centers of Western Michigan ( Site 0026)Grand Rapids, United StatesRecruiting
  • Allina Health Cancer Institute ( Site 0069)Minneapolis, United StatesRecruiting
  • Hattiesburg Clinic Hematology/Oncology ( Site 0104)Hattiesburg, United StatesRecruiting
  • Comprehensive Cancer Centers of Nevada ( Site 0015)Las Vegas, United StatesRecruiting
  • Renown Regional Medical Center ( Site 0005)Reno, United StatesRecruiting
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)Hackensack, United StatesRecruiting

And 246 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-2870-011
  • U1111-1311-2310
  • 2024-516834-36-00
Sources for references
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)

Conditions (1)

Targets (31)