A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (INTerpath-001) - V940-001

Merck Sharp & Dohme LLC0 个研究点目标入组 1,165 人开始时间: 2023年5月30日最近更新: 2024年8月21日

适应症

试验速览

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•Has resected cutaneous melanoma with histological confirmed stage IIB to IV., HCV infected participants are eligible if HCV viral load is undetectable at screening., HIV-infected participants must have well controlled HIV on ART., Has not received any prior systemic therapy for their melanoma beyond surgical resection., Complete resection that rendered the participant disease-free within 13 weeks prior to the first dose of pembrolizumab., Has a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing., Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases., All suspicious lesions amenable to biopsy should be confirmed negative for malignancy., Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1., Adequate organ function, specimens must be collected within 7 days before the start of study intervention., HBsAg positive participants have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.

•Has ocular or mucosal melanoma., Active autoimmune disease., Pneumonitis/interstitial lung disease or a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids., Active infection requiring treatment., HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Known active hepatitis B or C., Has history of allogeneic tissue/solid organ transplant., Has unresectable in-transit metastases., Clinically significant heart failure., Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample., Has received prior anticancer systemic or immunotherapy or another cancer vaccine or radiotherapy before starting of study intervention., Live or live-attenuated vaccine within 30 days prior to the first dose of study intervention., Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab., Known additional malignancy that is progressing or has required active treatment within the past 3 years., History of CNS metastases and/or carcinomatous meningitis.

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