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)

Last updated: March 25, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Squamous Cell Carcinoma

Warts

Cancer/tumors

Treatment

MK-3475A

Pembrolizumab (+) Berahyaluronidase alfa

Clinical Study ID

NCT06041802
3475A-E39
jRCT2041230074
MK-3475A-E39
  • Ages > 18
  • All Genders

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 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

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: MK-3475A
Phase: 2
Study Start date:
October 20, 2023
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Nagoya University Hospital ( Site 0003)

    Nagoya, Aichi 466-8560
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital ( Site 0002)

    Sapporo, Hokkaido 060-8543
    Japan

    Active - Recruiting

  • Shinshu University Hospital ( Site 0011)

    Matsumoto, Nagano 390-8621
    Japan

    Active - Recruiting

  • Niigata Cancer Center Hospital ( Site 0005)

    Niigata-shi, Niigata 951-8566
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center ( Site 0008)

    Hidaka, Saitama 350-1298
    Japan

    Active - Recruiting

  • Shimane University Hospital ( Site 0014)

    Izumo, Shimane 693-8501
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center ( Site 0004)

    Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital ( Site 0007)

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Chiba University Hospital ( Site 0001)

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • National Hospital Organization Kagoshima Medical Center ( Site 0013)

    Kagoshima, 892-0853
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute ( Site 0009)

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Keio University Hospital ( Site 0010)

    Tokyo, 1608582
    Japan

    Active - Recruiting

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