A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MK-3475A in Japanese Participants with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) unresectable cSCC

Koh Yasuhiro0 个研究点目标入组 19 人开始时间: 2023年9月4日最近更新: 2024年4月23日

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•Has histologically-confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
•R/M cSCC only:
•-Has cSCC that is either metastatic defined as disseminated disease distant to the initial/primary site of diagnosis, and/or must have locally recurrent disease that has been previously treated (with either surgery or radiotherapy) and is not curable by either surgery or radiotherapy.
•LA unresectable cSCC only:
•-Must be ineligible for surgical resection.
•-Participants who received prior radiation therapy (RT) to index site or must be deemed to be not eligible for RT.
•-Participants who received prior systemic therapy for curative intent are eligible regardless of regimen.
•-Has a life expectancy of at least 3 months.

•-Has cSCC that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
•-Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study.
•-Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study allocation.
•-Has not adequately recovered from major surgery or has ongoing surgical complications.
•-Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
•-Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
•-Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
•-Has an active autoimmune disease that has required systemic treatment in the past 2 years.
•-Has an active infection requiring systemic therapy.
•-Has a known history of human immunodeficiency virus (HIV) infection.
•-History of allogenic tissue/solid organ transplant.

发起方

Koh Yasuhiro