History of Changes for Study: NCT06041802

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)

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	September 11, 2023	None (earliest Version on record)
2	September 28, 2023	Oversight and Study Status
3	October 13, 2023	Study Status
4	October 25, 2023	Recruitment Status, Study Status and Contacts/Locations
5	November 3, 2023	Study Status and Contacts/Locations
6	December 7, 2023	Study Status, Contacts/Locations, Outcome Measures and Study Identification
7	December 21, 2023	Contacts/Locations and Study Status
8	December 28, 2023	Contacts/Locations and Study Status
9	February 2, 2024	Study Status and Contacts/Locations
10	February 8, 2024	Contacts/Locations and Study Status
11	April 19, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	3475A-E39
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.
Secondary IDs:	MK-3475A-E39 [Merck] jRCT2041230074 [Registry Identifier: Japan Registry of Clinical Trials (RCT)]

Study Status


Record Verification:	September 2023
Overall Status:	Not yet recruiting
Study Start:	October 12, 2023
Primary Completion:	March 2, 2027 [Anticipated]
Study Completion:	March 2, 2027 [Anticipated]

First Submitted:	September 11, 2023
First Submitted that Met QC Criteria:	September 11, 2023
First Posted:	September 18, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	September 11, 2023
Last Update Posted:	September 18, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Merck Sharp & Dohme LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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).

Detailed Description:

Conditions


Conditions:	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)

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	19 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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:
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


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
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/Locations


Study Officials:	Medical Director Study Director Merck Sharp & Dohme LLC
Locations:

IPDSharing


Plan to Share IPD:	Yes http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: http://engagezone.msd.com/ds_documentation.php

References


Citations:
Links:	URL: https://www.merckclinicaltrials.com/ Description: Merck Clinical Trials Information
Available IPD/Information: