Clinical trial NCT06041802: 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)
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 40 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to approximately 40 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 40 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 40 months
measure: Number of Participants who Experience an Adverse Event (AE)
timeFrame: Up to approximately 28 months
measure: Number of Participants who Discontinue Due to an AE
timeFrame: Up to approximately 25 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 0003)
state: Aichi
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 0002)
state: Hokkaido
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 0016)
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 0019)
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital ( Site 0011)
state: Nagano
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0005)
state: Niigata
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 0008)
state: Saitama
city: Izumo
country: Japan
facility: Shimane University Hospital ( Site 0014)
state: Shimane
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center ( Site 0004)
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital ( Site 0007)
state: Tokyo
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 0018)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 0001)
city: Kagoshima
country: Japan
facility: National Hospital Organization Kagoshima Medical Center ( Site 0013)
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0009)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0010)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 0015)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: