Status:
RECRUITING
A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) pembrolizumab (+) berahyaluronidase alfa in Japanese participants with recurrent or metastatic cuta...
Eligibility Criteria
Inclusion
- The key inclusion and exclusion criteria include but are not limited to the following:
- Has histologically confirmed cSCC by the investigator as the primary site of malignancy
- R/M cSCC cohort only: Has metastatic disease, defined as disseminated disease distant to the initial/primary site of diagnosis, and/or has 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 cohort only: Is ineligible for surgical resection
- LA unresectable cSCC cohort only: Has received prior radiation therapy (RT) to index site or has been deemed to be not eligible for RT
- LA unresectable cSCC cohort only: Has received prior systemic therapy for curative intent are eligible regardless of regimen
- Has a life expectancy of greater than 3 months
- Must provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Exclusion
- 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 anticancer therapy including investigation agents within 4 weeks before allocation
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Received prior radiotherapy within 2 weeks of study intervention, or had radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has an ongoing active infection requiring systemic therapy
- Has a history of human immunodeficiency virus (HIV) infection
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has history of allogenic tissue/organ transplant
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06041802
Start Date
October 20 2023
End Date
March 31 2028
Last Update
December 15 2025
Active Locations (18)
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1
Nagoya University Hospital ( Site 0003)
Nagoya, Aichi-ken, Japan, 466-8560
2
Sapporo Medical University Hospital ( Site 0002)
Sapporo, Hokkaido, Japan, 060-8543
3
Yokohama City University Hospital ( Site 0016)
Yokohama, Kanagawa, Japan, 236-0004
4
Tohoku University Hospital ( Site 0019)
Sendai, Miyagi, Japan, 980-8574