A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302) - MK-3475-679

Incyte Corp.0 个研究点目标入组 68 人开始时间: 2024年4月12日最近更新: 2024年7月22日

试验速览

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•Histologic confirmation of locally advanced or metastatic renal cell carcinoma (mRCC) with a clear-cell component with or without sarcomatoid features., Must not have received any prior systemic therapy for their mRCC., Measurable disease based on Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)., Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required., Karnofsky performance status = 70%., Adequate organ function per protocol-defined criteria.

•Use of protocol-defined prior/concomitant therapy., Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization., History of severe hypersensitivity reaction to study treatments or their excipients., Active autoimmune disease that has required systemic treatment in past 2 years., Known additional malignancy that has progressed or has required active treatment in the last 3 years., Known active central nervous system metastases and/or carcinomatous meningitis., History of (noninfectious) pneumonitis that required steroids or current pneumonitis., History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful., Significant cardiac event within 12 months before Cycle 1 Day 1.

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