Phase
Condition
Warts
Cancer/tumors
Lung Cancer
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
JapanSite Not Available
Nagoya University Hospital ( Site 0003)
Nagoya 1856057, Aichi-ken 1865694 466-8560
JapanSite Not Available
Sapporo Medical University Hospital ( Site 0002)
Sapporo, Hokkaido 060-8543
JapanSite Not Available
Sapporo Medical University Hospital ( Site 0002)
Sapporo 2128295, Hokkaido 2130037 060-8543
JapanSite Not Available
Yokohama City University Hospital ( Site 0016)
Yokohama, Kanagawa 236-0004
JapanSite Not Available
Yokohama City University Hospital ( Site 0016)
Yokohama 1848354, Kanagawa 1860291 236-0004
JapanSite Not Available
Tohoku University Hospital ( Site 0019)
Sendai, Miyagi 980-8574
JapanSite Not Available
Tohoku University Hospital ( Site 0019)
Sendai 2111149, Miyagi 2111888 980-8574
JapanSite Not Available
Shinshu University Hospital ( Site 0011)
Matsumoto, Nagano 390-8621
JapanSite Not Available
Shinshu University Hospital ( Site 0011)
Matsumoto 1857519, Nagano 1856210 390-8621
JapanSite Not Available
Niigata Cancer Center Hospital ( Site 0005)
Niigata-shi, Niigata 951-8566
JapanSite Not Available
Niigata Cancer Center Hospital ( Site 0005)
Niigata 1855431, Niigata 1855429 951-8566
JapanSite Not Available
Saitama Medical University International Medical Center ( Site 0008)
Hidaka, Saitama 350-1298
JapanSite Not Available
Saitama Medical University International Medical Center ( Site 0008)
Hidaka 6822161, Saitama 1853226 350-1298
JapanSite Not Available
Shimane University Hospital ( Site 0014)
Izumo, Shimane 693-8501
JapanSite Not Available
Shimane University Hospital ( Site 0014)
Izumo 1861084, Shimane 1852442 693-8501
JapanSite Not Available
Shizuoka Cancer Center ( Site 0004)
Nagaizumi-cho,Sunto-gun, Shizuoka 1851715 411-8777
JapanSite Not Available
National Cancer Center Hospital ( Site 0007)
Chuo-ku, Tokyo 1850144 104-0045
JapanSite Not Available
Cancer Institute Hospital of JFCR ( Site 0018)
Koto, Tokyo 1850144 135-8550
JapanSite Not Available
Chiba University Hospital ( Site 0001)
Chiba, 260-8677
JapanSite Not Available
Chiba University Hospital ( Site 0001)
Chiba 2113015, 260-8677
JapanSite Not Available
National Hospital Organization Kyushu Cancer Center ( Site 0017)
Fukuoka, 811-1395
JapanSite Not Available
National Hospital Organization Kyushu Cancer Center ( Site 0017)
Fukuoka 1863967, 811-1395
JapanSite Not Available
National Hospital Organization Kagoshima Medical Center ( Site 0013)
Kagoshima, 892-0853
JapanSite Not Available
National Hospital Organization Kagoshima Medical Center ( Site 0013)
Kagoshima 1860827, 892-0853
JapanSite Not Available
University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
Kyoto, 602-8566
JapanSite Not Available
University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
Kyoto 1857910, 602-8566
JapanSite Not Available
Osaka International Cancer Institute ( Site 0009)
Osaka, 541-8567
JapanSite Not Available
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0009)
Osaka 1853909, 541-8567
JapanSite Not Available
Keio university hospital ( Site 0010)
Tokyo, 1608582
JapanSite Not Available
Keio University Hospital ( Site 0010)
Tokyo 1850147, 1608582
JapanSite Not Available
Wakayama Medical University Hospital ( Site 0015)
Wakayama, 641-8510
JapanSite Not Available
Wakayama Medical University Hospital ( Site 0015)
Wakayama 1926004, 641-8510
JapanSite Not Available

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