Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 TNBC - 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 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 TNBC - Has Grade ≥2 peripheral neuropathy - Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or 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 - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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. Additionally, participants may receive rescue medication per approved product label, at the discretion of the investigator.
  • Biological: Sacituzumab tirumotecan
    IV Infusion
    Other names:
    • Sac-TMT
    • MK-2870
  • Drug: Rescue Medication
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
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). Additionally, participants may receive rescue medication per approved product label, at the discretion of the investigator.
  • Biological: Sacituzumab tirumotecan
    IV Infusion
    Other names:
    • Sac-TMT
    • MK-2870
  • Biological: Pembrolizumab
    IV Infusion
    Other names:
    • MK-3475
    • Keytruda®
  • Drug: Rescue Medication
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
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.
  • Drug: Paclitaxel
    IV Infusion
    Other names:
    • Taxol
    • Onxol
  • Drug: Nab-paclitaxel
    IV Infusion
    Other names:
    • Abraxane
  • Drug: Gemcitabine
    IV Infusion
    Other names:
    • Gemzar
  • Drug: Carboplatin
    IV Infusion
    Other names:
    • Paraplatin

Recruiting Locations

MedStar Franklin Square Medical Center ( Site 0031)
Baltimore, Maryland 21237
Contact:
Study Coordinator
443-777-7147

MedStar Good Samaritan Hospital ( Site 0079)
Baltimore, Maryland 21239
Contact:
Study Coordinator
443-777-7147

MedStar Montgomery Medical Center ( Site 0078)
Olney, Maryland 20832
Contact:
Study Coordinator
301-774-8882

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.