Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

NCT06393374
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,530
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2024-06-24
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Number of sites
309
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Summary
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
clinicaltrials.gov
Short title
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
clinicaltrials.gov
Official title
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
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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
2037-12-14
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First posted
2024-05-01
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Registry last updated
2026-08-28
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Primary completion date
2030-12-16
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Start date
2024-06-24
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Participants
1,530
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Participant count basis
Estimated
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Planned participants
1,530
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Protocol amendments
5
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Number of sites
309
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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
NCT06393374
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06393374
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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. Invasive Disease-Free Survival (iDFS)

    Timeframe: Up to ~77 months

    iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.

  1. Overall Survival (OS)

    Timeframe: Up to ~101 months

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

  2. Distant recurrence-free survival (DRFS)

    Timeframe: Up to ~101 months

    DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.

  3. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    Timeframe: Baseline and up to ~60 months

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.

  4. Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    Timeframe: Baseline and up to ~60 months

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning.

  5. Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    Timeframe: Baseline and up to ~60 months

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning.

  6. Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score

    Timeframe: Baseline and up to ~60 months

    EORTC QLQ-C30 is a 30-item scale 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"). Lower scores indicate a better level of fatigue.

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

    Timeframe: Up to ~42 weeks

    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.

  8. Number of participants who discontinue study intervention due to an AE

    Timeframe: Up to 24 weeks

    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

  • Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Has no evidence of locoregional or distant relapse, as assessed by the treating physician
  • Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
  • Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
  • Has non-pathologic complete response at surgery
  • Is able to continue on adjuvant pembrolizumab
  • Randomization must be conducted within 16 weeks from surgical resection
  • Completed adjuvant radiation therapy (if indicated) and recovered before randomization
  • Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status
  • If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine [no restriction for pembrolizumab]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
  • For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization

  • Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
  • Has Grade >2 peripheral neuropathy
  • 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
  • Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
  • Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
  • Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
  • Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137)
  • Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
  • Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has concurrent active hepatitis B and hepatitis C virus infection
  • Has history of allogeneic tissue/solid organ transplant
Sources for eligibility
clinicaltrials.gov

  • Infirmary Cancer Care ( Site 0001)Mobile, United StatesRecruiting
  • Ironwood Cancer & Research Centers-Research ( Site 0054)Chandler, United StatesRecruiting
  • MemorialCare Orange Coast Medical Center ( Site 9501)Fountain Valley, United StatesRecruiting
  • Scripps Cancer Center ( Site 0052)La Jolla, United StatesRecruiting
  • Cancer and Blood Specialty Clinic ( Site 0008)Los Alamitos, United StatesCompleted
  • Kaiser Permanente - Oakland ( Site 0079)Oakland, United StatesRecruiting
  • Profound Research LLC ( Site 0105)Oceanside, United StatesRecruiting
  • Kaiser Permanente - Roseville ( Site 0081)Roseville, United StatesRecruiting
  • Kaiser Permanente - San Francisco ( Site 0080)San Francisco, United StatesRecruiting
  • Kaiser Permanente - Santa Clara ( Site 0082)Santa Clara, United StatesRecruiting
  • Providence Medical Foundation ( Site 9543)Santa Rosa, United StatesRecruiting
  • Kaiser Permanente Vallejo Medical Center ( Site 0060)Vallejo, United StatesRecruiting
  • Kaiser Permanente - Walnut Creek ( Site 0078)Walnut Creek, United StatesRecruiting
  • Bass Medical Group ( Site 0089)Walnut Creek, United StatesCompleted
  • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)Grand Junction, United StatesRecruiting
  • University of Connecticut Health Center ( Site 0128)Farmington, United StatesRecruiting
  • Yale Cancer Center ( Site 0053)New Haven, United StatesRecruiting
  • Helen F. Graham Cancer Center & Research Institute ( Site 0018)Newark, United StatesRecruiting
  • AdventHealth Altamonte Springs ( Site 0125)Altamonte Springs, United StatesRecruiting
  • Orlando Health Cancer Institute ( Site 0030)Orlando, United StatesRecruiting
  • Comprehensive Hematology Oncology ( Site 0091)St. Petersburg, United StatesRecruiting
  • Cleveland Clinic Martin North Hospital ( Site 0114)Stuart, United StatesRecruiting
  • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)Thomasville, United StatesCompleted
  • Illinois Cancer Specialists (ICS) ( Site 8010)Arlington Heights, United StatesRecruiting
  • Orchard Healthcare Research Inc. ( Site 0014)Skokie, United StatesRecruiting

And 284 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • U1111-1289-8264
  • 2023-504962-52-00
  • jRCT2031240476
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (2)