Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)
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|ClinicalTrials.gov Identifier: NCT03284424|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2017
Results First Posted : November 19, 2021
Last Update Posted : July 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Biological: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)|
|Actual Study Start Date :||October 26, 2017|
|Actual Primary Completion Date :||July 29, 2020|
|Estimated Study Completion Date :||June 15, 2023|
Experimental: R/M cSCC cohort
Participants with R/M cSCC receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Experimental: LA cSCC cohort
Participants with LA cSCC receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 31.8 months (database cutoff date 29-Jul-2020) ]ORR was defined as the percentage of participants who have best response of 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, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented.
- Duration of Response (DOR) [ Time Frame: Up to approximately 56 months ]
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 56 months ]
- Progression-free Survival (PFS) [ Time Frame: Up to approximately 56 months ]
- Overall Survival (OS) [ Time Frame: Up to approximately 56 months ]
- Number of Participants Who Experienced One or More Adverse Events (AEs) [ Time Frame: Up to approximately 56 months ]
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 56 months ]
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): NCT03284424
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|