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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)

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ClinicalTrials.gov Identifier: NCT06041802
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Actual Study Start Date : October 20, 2023
Estimated Primary Completion Date : March 2, 2027
Estimated Study Completion Date : March 2, 2027

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 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 :
  1. Duration of Response (DOR) [ Time Frame: 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.

  2. Disease Control Rate (DCR) [ Time Frame: 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.

  3. Overall Survival (OS) [ Time Frame: Up to approximately 40 months ]
    OS is defined as the time from first dose of study treatment to death due to any cause.

  4. Number of Participants who Experience an Adverse Event (AE) [ Time Frame: 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.

  5. Number of Participants who Discontinue Due to an AE [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041802


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Japan
Shizuoka Cancer Center ( Site 0004) Recruiting
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Study Coordinator    81559895222      
Chiba University Hospital ( Site 0001) Recruiting
Chiba, Japan, 260-8677
Contact: Study Coordinator    043-222-7171      
Keio university hospital ( Site 0010) Recruiting
Tokyo, Japan, 1608582
Contact: Study Coordinator    +81-3-3353-1211      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06041802    
Other Study ID Numbers: 3475A-E39
MK-3475A-E39 ( Other Identifier: Merck )
jRCT2041230074 ( Registry Identifier: Japan Registry of Clinical Trials (RCT) )
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
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)
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action