A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma - V940-004

Merck Sharp & Dohme LLC0 个研究点目标入组 296 人开始时间: 2023年11月13日最近更新: 2024年8月21日

适应症

试验速览

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•Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology., Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: a.Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0 b.High-risk RCC: pT4, N0, M0; pT any stage, N1, M0 c.M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or =2 years from nephrectomy (metachronous), Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants., Must have undergone a nephrectomy and/or metastasectomy =12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization., Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

•Has had a major surgery within 4 weeks prior to randomization., Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication., Has an active autoimmune disease that has required systemic treatment in the past 2 years., Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has an active infection requiring systemic therapy., History of allogeneic tissue/solid organ transplant., Has not adequately recovered from major surgery or has ongoing surgical complications., Has residual thrombus post nephrectomy in the vena renalis or vena cava., Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization., Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids., Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed., Received prior treatment with a cancer vaccine., Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy., Has a known additional malignancy that is progressing or has required active treatment within the past 3 years., Has a history of brain or bone metastatic lesions.

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