Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma or Locally Advanced unresectable cSCC
Conditions
Interventions
All participants will receive a dose of MK-3475A 790 mg by subcutaneous (SC) administration every 6 weeks (Q6W).
Sponsors
Fujita Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) Disease control (DC) Overall Survival (OS) Adverse Events Study drug discontinuations due to adverse events | — |
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed