2023-504962-52-00
Recruiting
Phase 3
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
Merck Sharp & Dohme LLC106 sites in 7 countries571 target enrollmentStarted: June 11, 2024Last updated:
Interventions-
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 571
- Locations
- 106
- Primary Endpoint
- Invasive Disease-Free Survival (iDFS)
Overview
Brief Summary
To compare MK-2870 plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to iDFS per investigator assessment
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has centrally confirmed triple negative breast cancer (TNBC), as defined by the most recent American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines.
- •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 MK-2870 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 MK-2870, 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 HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- •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) and/or local 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.
Exclusion Criteria
- •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.
- •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.
- •Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- •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.
- •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.
- •Active infection requiring systemic therapy.
Arms & Interventions
-
Auxiliary
Participants receiving -
Intervention: - (Drug)
Outcomes
Primary Outcomes
Invasive Disease-Free Survival (iDFS)
Invasive Disease-Free Survival (iDFS)
Secondary Outcomes
- Overall Survival (OS)
- Distant Recurrence-Free Survival (DRFS)
- Change from Baseline in European Organisation for 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
- Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
- Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
- Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue (Items 10, 12, 18) Score
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Intervention Due to an AE
Investigators
Wilbur Pan
Scientific
Merck Sharp & Dohme LLC
Study Sites (106)
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