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)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06041802

Collaborator

(none)

Enrollment

Arm

40.6

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma	Biological: MK-3475A	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Oct 12, 2023

Anticipated Primary Completion Date :

Mar 2, 2027

Anticipated Study Completion Date :

Mar 2, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MK-3475A Participants will receive MK-3475A subcutaneously for up to 18 administrations.	Biological: MK-3475A MK-3475A is a fixed-dose formulation of pembrolizumab and MK-5180 for SC administration.

Arm

Intervention/Treatment

Experimental: MK-3475A

Participants will receive MK-3475A subcutaneously for up to 18 administrations.

Biological: MK-3475A

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
Number of Participants who Experience an Adverse Event (AE) [Up to approximately 30 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.
Number of Participants who Discontinue Due to an AE [Up to approximately 27 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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