A Phase 2 Study of MK-3475A in Japanese Participants with Recurrent or Metastatic (R/M) or Locally Advanced (LA) unresectable Cutaneous Squamous Cell Carcinoma (cSCC)
- Conditions
- Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma or Locally Advanced unresectable cSCC
- Registration Number
- JPRN-jRCT2041230074
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 19
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) <br>Disease control (DC) <br>Overall Survival (OS)<br>Adverse Events<br>Study drug discontinuations due to adverse events