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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

MK-2870 Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Jan. 31, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-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 12 weeks from surgical resection.
-Completed adjuvant radiation therapy (if indicated) and recovered before randomization.
-For male participants, agrees to refrain from donating sperm and either abstains from penile-vaginal intercourse or uses approved contraception for 100 days after the last dose of MK-2870 and 95 days after the last dose of capecitabine.
-For female participants, is not a participant of childbearing potential (POCBP) or is a POCBP and uses highly effective contraception; agrees not to donate eggs for up to 190 days after the last dose of MK-2870, 120 days after the last dose of pembrolizumab, and 185 days after the last dose of capecitabine; has a negative highly sensitive pregnancy test before the first dose of study intervention; and agrees to abstain from breastfeeding for at least 120 days after last dose of study therapy.
-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 Virus (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 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 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 anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, Poly (ADP ribose) Polymerase (PARP) inhibitors, Antibody Drug Conjugates (ADCs), and/or immunotherapy, with the exception of adjuvant radiation therapy.
-Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study.
-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.

Both

Triple negative breast cancer

-Arm 1: MK-2870 4mg/kg intravenous (IV) every 2 weeks (q2w) plus pembrolizumab 400 mg every 6 weeks (q6w)
-Arm 2: TPC consisting of either pembrolizumab 400 mg q6w alone or pembrolizumab 400 mg q6w plus capecitabine 1000 mg/m2 to 1250 mg/m2 BID administered on Days 1 to 14 and Days 22 to 35 every 42 days x 4 (2 weeks on, 1 week off)

Invasive Disease-Free Survival (iDFS)

-Overall Survival (OS)
-Distant recurrence-free survival (DRFS)
-Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
-Adverse events (AEs), Study intervention discontinuations due to AEs

+81-82-221-2291

Sept. 25, 2024

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

USA/Canada/Argentina/Brazil/Mexico/Australia/Malaysia/Singapore/South Korea/Hong Kong/Austria/Belgium/Czechia/Denmark/Finland/France/Germany/Greece/Hungary/Ireland/Israel/Italy/Netherlands/Norway/Poland/Portugal/Spain/Sweden/Switzerland/Refer to 7-5