A Study of MK-3475A (Pembrolizumab Formulated With 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)

Squamous Cell Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041802
• Other study ID #: 3475A-E39
• Secondary ID: MK-3475A-E39jRCT
• Status: Recruiting
• Phase: Phase 2
• Start date: October 20, 2023
• Est. completion date: March 2, 2027

Study information

• Verified date: April 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) MK-3475A in Japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that MK-3475A 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: March 2, 2027
• Est. primary completion date: March 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Biological:
• MK-3475A
MK-3475A is a fixed-dose formulation of pembrolizumab and MK-5180 for SC administration.

Locations

Country	Name	City	State
Japan	Chiba University Hospital ( Site 0001)	Chiba
Japan	National Cancer Center Hospital ( Site 0007)	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center ( Site 0008)	Hidaka	Saitama
Japan	Shinshu University Hospital ( Site 0011)	Matsumoto	Nagano
Japan	Shizuoka Cancer Center ( Site 0004)	Nagaizumi-cho,Sunto-gun	Shizuoka
Japan	Nagoya University Hospital ( Site 0003)	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital ( Site 0005)	Niigata-shi	Niigata
Japan	Sapporo Medical University Hospital ( Site 0002)	Sapporo	Hokkaido
Japan	Keio university hospital ( Site 0010)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to approximately 40 months
Secondary	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.	Up to approximately 40 months
Secondary	Overall Survival (OS)	OS is defined as the time from first dose of study treatment to death due to any cause.	Up to approximately 40 months
Secondary	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.	Up to approximately 28 months
Secondary	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.	Up to approximately 25 months

External Links

•   Merck Clinical Trials Information