Phase
Condition
Squamous Cell Carcinoma
Warts
Cancer/tumors
Treatment
MK-3475A
Pembrolizumab (+) Berahyaluronidase alfa
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofmalignancy
R/M cSCC cohort only: Has metastatic disease, defined as disseminated diseasedistant to the initial/primary site of diagnosis, and/or has locally recurrentdisease that has been previously treated (with either surgery or radiotherapy) andis 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 indexsite or has been deemed to be not eligible for RT
LA unresectable cSCC cohort only: Has received prior systemic therapy for curativeintent 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 excisionalbiopsy of a tumor lesion not previously irradiated
Exclusion
Exclusion Criteria:
Has cSCC that can be cured with surgical resection, radiotherapy, or with acombination of surgery and radiotherapy.
Has any other histologic type of skin cancer other than invasive squamous cellcarcinoma 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 surgicalcomplications
Received prior radiotherapy within 2 weeks of study intervention, or hadradiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention
Known additional malignancy that is progressing or has required active treatmentwithin 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 2years
Has history of allogenic tissue/organ transplant
Study Design
Connect with a study center
Nagoya University Hospital ( Site 0003)
Nagoya, Aichi 466-8560
JapanActive - Recruiting
Sapporo Medical University Hospital ( Site 0002)
Sapporo, Hokkaido 060-8543
JapanActive - Recruiting
Shinshu University Hospital ( Site 0011)
Matsumoto, Nagano 390-8621
JapanActive - Recruiting
Niigata Cancer Center Hospital ( Site 0005)
Niigata-shi, Niigata 951-8566
JapanActive - Recruiting
Saitama Medical University International Medical Center ( Site 0008)
Hidaka, Saitama 350-1298
JapanActive - Recruiting
Shimane University Hospital ( Site 0014)
Izumo, Shimane 693-8501
JapanActive - Recruiting
Shizuoka Cancer Center ( Site 0004)
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
JapanActive - Recruiting
National Cancer Center Hospital ( Site 0007)
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
Chiba University Hospital ( Site 0001)
Chiba, 260-8677
JapanActive - Recruiting
National Hospital Organization Kagoshima Medical Center ( Site 0013)
Kagoshima, 892-0853
JapanActive - Recruiting
University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
Kyoto, 602-8566
JapanActive - Recruiting
Osaka International Cancer Institute ( Site 0009)
Osaka, 541-8567
JapanActive - Recruiting
Keio University Hospital ( Site 0010)
Tokyo, 1608582
JapanActive - Recruiting
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