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)

JRCT ID: jRCT2041230074

Registered date:04/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma or Locally Advanced unresectable cSCC
• Date of first enrollment: 20/10/2023
• Target sample size: 19
• Study type: Interventional
• Intervention(s): All participants will receive a dose of MK-3475A 790 mg by subcutaneous (SC) administration every 6 weeks (Q6W).

Outcome(s)

• Primary Outcome: Objective response

Secondary Outcome

Duration of response (DOR)
Disease control (DC)
Overall Survival (OS)
Adverse Events
Study drug discontinuations due to adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Koh Yasuhiro
• Secondary ID(s): NCT06041802