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)

Phase 2RecruitingNCT06041802

Merck Sharp & Dohme LLC19 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma

Interventions

Pembrolizumab (+) Berahyaluronidase alfa

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Nagoya University Hospital ( Site 0003)

Nagoya, Aichi-ken, Japan

RECRUITING

Sapporo Medical University Hospital ( Site 0002)

Sapporo, Hokkaido, Japan

RECRUITING

Yokohama City University Hospital ( Site 0016)

Yokohama, Kanagawa, Japan

RECRUITING

Tohoku University Hospital ( Site 0019)

Sendai, Miyagi, Japan

RECRUITING

Shinshu University Hospital ( Site 0011)

Matsumoto, Nagano, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 0005)

Niigata, 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

...and 8 more locations

Outcomes

Primary Outcomes

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.

Time frame: Up to approximately 40 months

Secondary Outcomes

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.

Time frame: Up to approximately 40 months

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.

Time frame: Up to approximately 40 months

Overall Survival (OS)

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

Time frame: Up to approximately 40 months

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.

Time frame: Up to approximately 28 months

Number of Participants who Discontinue Due to an AE

Time frame: Up to approximately 25 months

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)

Overview

Conditions

Interventions

Eligibility

Locations (18)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts