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New shot shows promise against tough skin cancer

NCT ID NCT06041802

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug combination (pembrolizumab plus berahyaluronidase alfa) given as a shot under the skin for Japanese patients with advanced squamous cell skin cancer that has spread or cannot be removed by surgery. The main goal is to see if the treatment can shrink tumors. About 19 people will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 19 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 skin squamous cell carcinoma squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma

Contacts and locations

Locations

  • Cancer Institute Hospital of JFCR ( Site 0018)

    Koto, Tokyo, 135-8550, Japan

  • Chiba University Hospital ( Site 0001)

    Chiba, 260-8677, Japan

  • Keio University Hospital ( Site 0010)

    Tokyo, 1608582, Japan

  • Nagoya University Hospital ( Site 0003)

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital ( Site 0007)

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Kagoshima Medical Center ( Site 0013)

    Kagoshima, 892-0853, Japan

  • National Hospital Organization Kyushu Cancer Center ( Site 0017)

    Fukuoka, 811-1395, Japan

  • Niigata Cancer Center Hospital ( Site 0005)

    Niigata, Niigata, 951-8566, Japan

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0009)

    Osaka, 541-8567, Japan

  • Saitama Medical University International Medical Center ( Site 0008)

    Hidaka, Saitama, 350-1298, Japan

  • Sapporo Medical University Hospital ( Site 0002)

    Sapporo, Hokkaido, 060-8543, Japan

  • Shimane University Hospital ( Site 0014)

    Izumo, Shimane, 693-8501, Japan

  • Shinshu University Hospital ( Site 0011)

    Matsumoto, Nagano, 390-8621, Japan

  • Shizuoka Cancer Center ( Site 0004)

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

  • Tohoku University Hospital ( Site 0019)

    Sendai, Miyagi, 980-8574, Japan

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

    Kyoto, 602-8566, Japan

  • Wakayama Medical University Hospital ( Site 0015)

    Wakayama, 641-8510, Japan

  • Yokohama City University Hospital ( Site 0016)

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.