NCT06041802Active, not recruitingPhase 2
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)
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.
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (estimated)
- First submitted
- 11 Sept 2023
- Start date
- Oct 2023
- Primary completion date
- Mar 2028
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT06041802
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 19
- From Oct 2023 to the primary completion date, Mar 2028
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has cSCC that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
- 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
Other illness
- Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- The key inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chiba University Hospital ( Site 0001) Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| National Cancer Center Hospital ( Site 0007) Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| National Hospital Organization Kyushu Cancer Center ( Site 0017) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Saitama Medical University International Medical Center ( Site 0008) Coordinator of this site? Confirm its status | Hidaka | Japan | Unknown status |
| Shimane University Hospital ( Site 0014) Coordinator of this site? Confirm its status | Izumo | Japan | Unknown status |
| National Hospital Organization Kagoshima Medical Center ( Site 0013) Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Cancer Institute Hospital of JFCR ( Site 0018) Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| University Hospital,Kyoto Prefectural University of Medicine ( Site 0012) Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Shinshu University Hospital ( Site 0011) Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Shizuoka Cancer Center ( Site 0004) Coordinator of this site? Confirm its status | Nagaizumi-cho,Sunto-gun | Japan | Unknown status |
| Nagoya University Hospital ( Site 0003) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Niigata Cancer Center Hospital ( Site 0005) Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0009) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Sapporo Medical University Hospital ( Site 0002) Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku University Hospital ( Site 0019) Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Keio University Hospital ( Site 0010) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Wakayama Medical University Hospital ( Site 0015) Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Yokohama City University Hospital ( Site 0016) Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.