The purpose of this study is to evaluate the efficacy, safety, and tolerability ofsubcutaneous (SC) pembrolizumab (+) berahyaluronidase alfa in Japanese participants withrecurrent or metastatic cutaneous squamous cell carcinoma or locally advancedunresectable cSCC. The primary hypothesis is that pembrolizumab (+) berahyaluronidasealfa will result in greater than 10% objective response rate (ORR) per ResponseEvaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by BlindedIndependent Central Review (BICR).
Not Provided
Biological: Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab and
berahyaluronidase alfa for SC administration.
Other Name: MK-3475A
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- 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 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 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
Nagoya University Hospital ( Site 0003)
Nagoya, Aichi, Japan
Sapporo Medical University Hospital ( Site 0002)
Sapporo, Hokkaido, Japan
Yokohama City University Hospital ( Site 0016)
Yokohama, Kanagawa, Japan
Shinshu University Hospital ( Site 0011)
Matsumoto, Nagano, Japan
Niigata Cancer Center Hospital ( Site 0005)
Niigata-shi, Niigata, Japan
Saitama Medical University International Medical Center ( Site 0008)
Hidaka, Saitama, Japan
Shimane University Hospital ( Site 0014)
Izumo, Shimane, Japan
Shizuoka Cancer Center ( Site 0004)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 0007)
Chuo-ku, Tokyo, Japan
Chiba University Hospital ( Site 0001)
Chiba, Japan
National Hospital Organization Kagoshima Medical Center ( Site 0013)
Kagoshima, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
Kyoto, Japan
Osaka International Cancer Institute ( Site 0009)
Osaka, Japan
Keio University Hospital ( Site 0010)
Tokyo, Japan
Toll Free Number
1-888-577-8839
Trialsites@msd.com
Medical Director, Study Director
Merck Sharp & Dohme LLC