Official Title
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MK-3475A in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC.
Brief Summary

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).

Detailed Description

Not Provided

Active, not recruiting
Squamous Cell Carcinoma

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab and
berahyaluronidase alfa for SC administration.
Other Name: MK-3475A

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Japan
Locations

Nagoya University Hospital ( Site 0003)
Nagoya 1856057, Aichi-ken 1865694, Japan

Sapporo Medical University Hospital ( Site 0002)
Sapporo 2128295, Hokkaido 2130037, Japan

Yokohama City University Hospital ( Site 0016)
Yokohama 1848354, Kanagawa 1860291, Japan

Tohoku University Hospital ( Site 0019)
Sendai 2111149, Miyagi 2111888, Japan

Shinshu University Hospital ( Site 0011)
Matsumoto 1857519, Nagano 1856210, Japan

Niigata Cancer Center Hospital ( Site 0005)
Niigata 1855431, Niigata 1855429, Japan

Saitama Medical University International Medical Center ( Site 0008)
Hidaka 6822161, Saitama 1853226, Japan

Shimane University Hospital ( Site 0014)
Izumo 1861084, Shimane 1852442, Japan

Shizuoka Cancer Center ( Site 0004)
Nagaizumi-cho,Sunto-gun, Shizuoka 1851715, Japan

National Cancer Center Hospital ( Site 0007)
Chuo-ku, Tokyo 1850144, Japan

Cancer Institute Hospital of JFCR ( Site 0018)
Koto, Tokyo 1850144, Japan

Chiba University Hospital ( Site 0001)
Chiba 2113015, Japan

National Hospital Organization Kyushu Cancer Center ( Site 0017)
Fukuoka 1863967, Japan

National Hospital Organization Kagoshima Medical Center ( Site 0013)
Kagoshima 1860827, Japan

University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
Kyoto 1857910, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0009)
Osaka 1853909, Japan

Keio University Hospital ( Site 0010)
Tokyo 1850147, Japan

Wakayama Medical University Hospital ( Site 0015)
Wakayama 1926004, Japan

Medical Director, Study Director
Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC
NCT Number
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
MeSH Terms
Carcinoma, Squamous Cell
Parkinson Disease 4, Autosomal Dominant Lewy Body
Pembrolizumab