NCT06041802

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
23mo left

Started Oct 2023

Typical duration for phase_2

Geographic Reach
1 country

18 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Oct 2023Mar 2028

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

September 11, 2023

Last Update Submit

February 13, 2026

Conditions

Squamous Cell Carcinoma

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)

Outcome Measures

Primary Outcomes (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.

    Up to approximately 40 months

Secondary Outcomes (5)

  • Duration of Response (DOR)

    Up to approximately 40 months

  • Disease Control Rate (DCR)

    Up to approximately 40 months

  • Overall Survival (OS)

    Up to approximately 40 months

  • Number of Participants who Experience an Adverse Event (AE)

    Up to approximately 28 months

  • Number of Participants who Discontinue Due to an AE

    Up to approximately 25 months

Study Arms (1)

Pembrolizumab (+) Berahyaluronidase alfa

EXPERIMENTAL

Participants will receive pembrolizumab (+) berahyaluronidase alfa subcutaneously for up to 18 administrations.

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Interventions

Pembrolizumab (+) Berahyaluronidase alfaBIOLOGICAL

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

Also known as: MK-3475A
Pembrolizumab (+) Berahyaluronidase alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Nagoya University Hospital ( Site 0003)

Nagoya, Aichi-ken, 466-8560, Japan

Location

Sapporo Medical University Hospital ( Site 0002)

Sapporo, Hokkaido, 060-8543, Japan

Location

Yokohama City University Hospital ( Site 0016)

Yokohama, Kanagawa, 236-0004, Japan

Location

Tohoku University Hospital ( Site 0019)

Sendai, Miyagi, 980-8574, Japan

Location

Shinshu University Hospital ( Site 0011)

Matsumoto, Nagano, 390-8621, Japan

Location

Niigata Cancer Center Hospital ( Site 0005)

Niigata, Niigata, 951-8566, Japan

Location

Saitama Medical University International Medical Center ( Site 0008)

Hidaka, Saitama, 350-1298, Japan

Location

Shimane University Hospital ( Site 0014)

Izumo, Shimane, 693-8501, Japan

Location

Shizuoka Cancer Center ( Site 0004)

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

Location

National Cancer Center Hospital ( Site 0007)

Chuo-ku, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR ( Site 0018)

Koto, Tokyo, 135-8550, Japan

Location

Chiba University Hospital ( Site 0001)

Chiba, 260-8677, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 0017)

Fukuoka, 811-1395, Japan

Location

National Hospital Organization Kagoshima Medical Center ( Site 0013)

Kagoshima, 892-0853, Japan

Location

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

Kyoto, 602-8566, Japan

Location

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

Osaka, 541-8567, Japan

Location

Keio University Hospital ( Site 0010)

Tokyo, 1608582, Japan

Location

Wakayama Medical University Hospital ( Site 0015)

Wakayama, 641-8510, Japan

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Squamous CellParkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

October 20, 2023

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

JP(18)