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)
Pembrolizumab (+) Berahyaluronidase alfa: Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab and berahyaluronidase alfa for SC administration.
Study 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 cutaneous squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that pembrolizumab (+) berahyaluronidase alfa will result in greater than 10% objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Objective Response Rate (ORR) — Up to approximately 40 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Trial sites (18)
Facility
City
Region
Status
Nagoya University Hospital ( Site 0003)
Nagoya
Aichi-ken
Sapporo Medical University Hospital ( Site 0002)
Sapporo
Hokkaido
Yokohama City University Hospital ( Site 0016)
Yokohama
Kanagawa
Tohoku University Hospital ( Site 0019)
Sendai
Miyagi
Shinshu University Hospital ( Site 0011)
Matsumoto
Nagano
Niigata Cancer Center Hospital ( Site 0005)
Niigata
Niigata
Saitama Medical University International Medical Center ( Site 0008)
Hidaka
Saitama
Shimane University Hospital ( Site 0014)
Izumo
Shimane
Shizuoka Cancer Center ( Site 0004)
Nagaizumi-cho,Sunto-gun
Shizuoka
National Cancer Center Hospital ( Site 0007)
Chuo-ku
Tokyo
Cancer Institute Hospital of JFCR ( Site 0018)
Koto
Tokyo
Chiba University Hospital ( Site 0001)
Chiba
Japan
National Hospital Organization Kyushu Cancer Center ( Site 0017)
Fukuoka
Japan
National Hospital Organization Kagoshima Medical Center ( Site 0013)
Kagoshima
Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
Kyoto
Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0009)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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