Evaluating a new treatment for advanced skin cancer in Japanese patients

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.

This study is testing a new combination treatment for advanced skin cancer in Japanese patients to see if it can help more than 10% of them improve.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Merck Sharp & Dohme LLC (industry)
• Drugs / interventions: radiation, pembrolizumab
• Locations: 15 sites (Nagoya, Aichi and 14 other locations)
• Trial ID: NCT06041802 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of a combination treatment involving pembrolizumab and berahyaluronidase alfa in Japanese participants suffering from recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced unresectable cSCC. The primary goal is to determine if this treatment can achieve an objective response rate greater than 10% as measured by independent review. Participants will receive subcutaneous injections of the treatment and will be monitored for their response and any side effects. The study is designed to provide insights into a potentially effective therapy for a challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates include Japanese individuals with recurrent or metastatic cutaneous squamous cell carcinoma or those with locally advanced unresectable cSCC who have not responded to previous treatments.

Not a fit: Patients with early-stage cSCC that is amenable to surgical resection or radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced skin cancer, potentially improving their outcomes.

How similar studies have performed: Other studies involving pembrolizumab have shown promising results in treating various cancers, suggesting that this approach may also be effective for cSCC.

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

Where this trial is running

Nagoya, Aichi and 14 other locations

• Nagoya University Hospital ( Site 0003) — Nagoya, Aichi, Japan (RECRUITING)
• Sapporo Medical University Hospital ( Site 0002) — Sapporo, Hokkaido, Japan (RECRUITING)
• Yokohama City University Hospital ( Site 0016) — Yokohama, Kanagawa, Japan (RECRUITING)
• Shinshu University Hospital ( Site 0011) — Matsumoto, Nagano, Japan (RECRUITING)
• Niigata Cancer Center Hospital ( Site 0005) — Niigata-shi, Niigata, Japan (RECRUITING)
• Saitama Medical University International Medical Center ( Site 0008) — Hidaka, Saitama, Japan (RECRUITING)
• Shimane University Hospital ( Site 0014) — Izumo, Shimane, Japan (RECRUITING)
• Shizuoka Cancer Center ( Site 0004) — Nagaizumi-cho,Sunto-gun, Shizuoka, Japan (RECRUITING)
• National Cancer Center Hospital ( Site 0007) — Chuo-ku, Tokyo, Japan (RECRUITING)
• Chiba University Hospital ( Site 0001) — Chiba, Japan (RECRUITING)
• National Hospital Organization Kagoshima Medical Center ( Site 0013) — Kagoshima, Japan (RECRUITING)
• University Hospital,Kyoto Prefectural University of Medicine ( Site 0012) — Kyoto, Japan (RECRUITING)
• Osaka International Cancer Institute ( Site 0009) — Osaka, Japan (RECRUITING)
• Keio University Hospital ( Site 0010) — Tokyo, Japan (RECRUITING)
• Wakayama Medical University Hospital ( Site 0015) — Wakayama, Japan (RECRUITING)

Study contacts

• Study coordinator: Toll Free Number

Conditions: Squamous Cell Carcinoma, Programmed Cell Death-1, Programmed Cell Death 1 Ligand 1, Programmed Cell Death 1 Ligand 2