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)
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT06041802
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab (+) Berahyaluronidase alfa Pembrolizumab (+) Berahyaluronidase alfa Participants will receive pembrolizumab (+) berahyaluronidase alfa subcutaneously for up to 18 administrations.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 40 months 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.
- Secondary Outcome Measures
Name Time Method Number of Participants who Discontinue Due to an AE Up to approximately 25 months 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.
Duration of Response (DOR) Up to approximately 40 months 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.
Overall Survival (OS) Up to approximately 40 months OS is defined as the time from first dose of study treatment to death due to any cause.
Disease Control Rate (DCR) Up to approximately 40 months 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.
Number of Participants who Experience an Adverse Event (AE) Up to approximately 28 months 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.
Trial Locations
- Locations (15)
Wakayama Medical University Hospital ( Site 0015)
🇯🇵Wakayama, Japan
Nagoya University Hospital ( Site 0003)
🇯🇵Nagoya, Aichi, Japan
Sapporo Medical University Hospital ( Site 0002)
🇯🇵Sapporo, Hokkaido, Japan
Yokohama City University Hospital ( Site 0016)
🇯🇵Yokohama, Kanagawa, Japan
Shinshu University Hospital ( Site 0011)
🇯🇵Matsumoto, Nagano, Japan
Niigata Cancer Center Hospital ( Site 0005)
🇯🇵Niigata-shi, Niigata, Japan
Saitama Medical University International Medical Center ( Site 0008)
🇯🇵Hidaka, Saitama, Japan
Shimane University Hospital ( Site 0014)
🇯🇵Izumo, Shimane, Japan
Shizuoka Cancer Center ( Site 0004)
🇯🇵Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 0007)
🇯🇵Chuo-ku, Tokyo, Japan
Chiba University Hospital ( Site 0001)
🇯🇵Chiba, Japan
National Hospital Organization Kagoshima Medical Center ( Site 0013)
🇯🇵Kagoshima, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)
🇯🇵Kyoto, Japan
Osaka International Cancer Institute ( Site 0009)
🇯🇵Osaka, Japan
Keio University Hospital ( Site 0010)
🇯🇵Tokyo, Japan