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 sites19 target enrollmentSeptember 4, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 4, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Koh Yasuhiro

•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.