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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 15, 2017
Results First Submitted Date  ICMJE September 14, 2021
Results First Posted Date  ICMJE November 19, 2021
Last Update Posted Date July 1, 2022
Actual Study Start Date  ICMJE October 26, 2017
Actual Primary Completion Date July 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
ORR is 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) as assessed by blinded independent central review (BICR).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Duration of Response (DOR) [ Time Frame: Up to approximately 24 months ]
    For participants who demonstrate a CR or PR, DOR is defined as the time from first documented evidence of CR or PR per RECIST 1.1 as assessed by BICR until disease progression per RECIST 1.1 assessed by BICR or death due to any cause, whichever occurs first.
  • Disease Control Rate (DCR) [ Time Frame: Up to approximately 24 months ]
    DCR is defined as the percentage of participants who have CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.]) for at least 12 weeks per RECIST 1.1 as assessed by BICR.
  • Progression-free Survival (PFS) [ Time Frame: Up to approximately 24 months ]
    PFS is defined as the time from first day of study treatment to the first documented disease progression per RECIST 1.1 assessed by BICR or death due to any cause, whichever occurs first.
  • Overall Survival (OS) [ Time Frame: Up to approximately 24 months ]
    OS is defined as the time from first day of study treatment to death due to any cause.
  • Adverse Events (AEs) [ Time Frame: Up to approximately 27 months ]
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience one or more AEs will be presented.
  • Study Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 24 months ]
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma
Intervention  ICMJE Biological: Pembrolizumab
IV infusion
Other Names:
  • KEYTRUDA®
  • MK-3475
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Pembrolizumab
  • 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.
    Intervention: Biological: Pembrolizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 14, 2021)
159
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2017)
120
Estimated Study Completion Date  ICMJE June 15, 2023
Actual Primary Completion Date July 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • R/M cSCC cohort only:
  • Has cSCC that is either metastatic defined as disseminated disease, and/or unresectable disease that is not curable by surgery or radiation.
  • Has histologically-confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
  • LA cSCC cohort only:
  • Must be ineligible for surgical resection.
  • Participants who received prior radiation therapy (RT) to index site or must be deemed to be not eligible for RT.
  • Participants who received prior systemic therapy for curative intent are eligible regardless of regimen.
  • R/M cSCC cohort only:
  • Has metastatic disease defined as disseminated disease distant to the initial/primary site of diagnosis, and/or must have locally recurrent disease that has been previously treated (with either surgery or radiotherapy), and is not amenable to either curative surgery or radiotherapy.
  • Has measurable disease based on RECIST 1.1 as assessed by the central imaging vendor.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of study treatment.
  • Has adequate organ function.
  • Has a tissue sample adequate for programmed death-ligand 1 (PD-L1) testing as determined by central laboratory testing prior to study allocation.
  • Has a life expectancy >3 months.
  • Female participants of childbearing potential must agree to use an adequate method of contraception during the study treatment period and for at least 120 days after the last dose of study treatment.

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, e.g. basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), melanoma.
  • Has had any prior allogeneic solid organ or bone marrow transplantation.
  • Has received prior therapy with an anti-programmed death protein-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137]).
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study allocation.

(Notes: Participants must have recovered from all AEs due to previously administered therapies to ≤ Grade 1 or baseline. If a participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.)

  • Has received prior radiotherapy within 2 weeks of start of study treatment.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g. with use of disease-modifying agents, anticoagulants, corticosteroids or immunosuppressive drugs).
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Israel,   Mexico,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03284424
Other Study ID Numbers  ICMJE 3475-629
MK-3475-629 ( Other Identifier: Merck )
KEYNOTE-629 ( Other Identifier: Merck )
2017-000594-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP