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Squamous Cell CarcinomaPhase 2NCT06041802

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 study testing Pembrolizumab (+) Berahyaluronidase alfa in people with Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 18 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
Pembrolizumab (+) Berahyaluronidase alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
18 sitesJapan
Study dates
20 Oct 2023to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Japan18 sites

  • Chiba University Hospital ( Site 0001)

    Chiba, 260-8677

  • National Cancer Center Hospital ( Site 0007)

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center ( Site 0017)

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center ( Site 0008)

    Hidaka, Saitama, 350-1298

  • Shimane University Hospital ( Site 0014)

    Izumo, Shimane, 693-8501

  • National Hospital Organization Kagoshima Medical Center ( Site 0013)

    Kagoshima, 892-0853

  • Cancer Institute Hospital of JFCR ( Site 0018)

    Koto, Tokyo, 135-8550

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

    Kyoto, 602-8566

  • Shinshu University Hospital ( Site 0011)

    Matsumoto, Nagano, 390-8621

  • Shizuoka Cancer Center ( Site 0004)

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

  • Nagoya University Hospital ( Site 0003)

    Nagoya, Aichi-ken, 466-8560

  • Niigata Cancer Center Hospital ( Site 0005)

    Niigata, Niigata, 951-8566

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

    Osaka, 541-8567

  • Sapporo Medical University Hospital ( Site 0002)

    Sapporo, Hokkaido, 060-8543

  • Tohoku University Hospital ( Site 0019)

    Sendai, Miyagi, 980-8574

  • Keio University Hospital ( Site 0010)

    Tokyo, 1608582

  • Wakayama Medical University Hospital ( Site 0015)

    Wakayama, 641-8510

  • Yokohama City University Hospital ( Site 0016)

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

Official title: 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.

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).

Being tested
Pembrolizumab (+) Berahyaluronidase alfa
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Carcinoma, Squamous Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab (+) Berahyaluronidase alfaBiological

    Also called MK-3475A

    Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab and berahyaluronidase alfa for SC administration.

Study groups in NCT06041802
Study groupRoleWhat they receive
Pembrolizumab (+) Berahyaluronidase alfaExperimentalParticipants will receive pembrolizumab (+) berahyaluronidase alfa subcutaneously for up to 18 administrations.
Receives: Biological: Pembrolizumab (+) Berahyaluronidase alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 40 months

Secondary outcomes (5)

  1. Duration of Response (DOR)

    For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 40 months

  2. Disease Control Rate (DCR)

    DCR is defined, per RECIST 1.1, as the percentage of participants who demonstrate a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.]).The DCR as assessed by BICR will be presented.

    Measured: Up to approximately 40 months

  3. Overall Survival (OS)

    OS is defined as the time from first dose of study treatment to death due to any cause.

    Measured: Up to approximately 40 months

  4. Number of Participants who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be reported.

    Measured: Up to approximately 28 months

  5. Number of Participants who Discontinue Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start20 Oct 2023
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06041802
Sponsor's protocol ID
3475A-E39
Other IDs
MK-3475A-E39, jRCT2041230074
Status last verified
Feb 2026
First submitted
11 Sep 2023
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab (+) Berahyaluronidase alfa in people with Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 18 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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