Back to resultsA 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)
Primary Purpose
Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-3475A
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring 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)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MK-3475A
Arm Description
Participants will receive MK-3475A subcutaneously for up to 18 administrations.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Overall Survival (OS)
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)
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
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.
Full Information
NCT ID
NCT06041802
First Posted
September 11, 2023
Last Updated
October 13, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT06041802
Brief Title
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)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 26, 2023 (Anticipated)
Primary Completion Date
March 2, 2027 (Anticipated)
Study Completion Date
March 2, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MK-3475A
Arm Type
Experimental
Arm Description
Participants will receive MK-3475A subcutaneously for up to 18 administrations.
Intervention Type
Biological
Intervention Name(s)
MK-3475A
Intervention Description
MK-3475A is a fixed-dose formulation of pembrolizumab and MK-5180 for SC administration.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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 Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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
Title
Disease Control Rate (DCR)
Description
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
Title
Overall Survival (OS)
Description
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
Title
Number of Participants who Experience an Adverse Event (AE)
Description
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 30 months
Title
Number of Participants who Discontinue Due to an AE
Description
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.
Time Frame
Up to approximately 27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
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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