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

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, 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

Contacts

Toll Free Number
1-888-577-8839
Trialsites@msd.com

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
Carcinoma, Squamous Cell
Pembrolizumab