NIPH Clinical Trials Search

JRCT ID: jRCT2041230074

Registered date:04/09/2023

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)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRecurrent or Metastatic Cutaneous Squamous Cell Carcinoma or Locally Advanced unresectable cSCC
Date of first enrollment20/10/2023
Target sample size19
Countries of recruitment
Study typeInterventional
Intervention(s)All participants will receive a dose of MK-3475A 790 mg by subcutaneous (SC) administration every 6 weeks (Q6W).


Primary OutcomeObjective response
Secondary OutcomeDuration 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 maximumNot applicable
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


Public contact
Name MSDJRCT inquiry mailbox
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
Affiliation MSD K.K.
Scientific contact
Name Yasuhiro Koh
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
Affiliation MSD K.K.