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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03284424




Registration number
NCT03284424
Ethics application status
Date submitted
14/09/2017
Date registered
15/09/2017

Titles & IDs
Public title
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)
Scientific 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)
Secondary ID [1] 0 0
MK-3475-629
Secondary ID [2] 0 0
3475-629
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab

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.


Treatment: Other: Pembrolizumab
IV infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 32 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to approximately 56 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
Up to approximately 56 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to approximately 56 months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to approximately 56 months
Secondary outcome [5] 0 0
Number of Participants Who Experienced One or More Adverse Events (AEs)
Timepoint [5] 0 0
Up to approximately 56 months
Secondary outcome [6] 0 0
Number of Participants Who Discontinued Study Treatment Due to AE
Timepoint [6] 0 0
Up to approximately 56 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2023
Sample size
Target
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Orange Health Services ( Site 0406) - Orange
Recruitment hospital [2] 0 0
Southern Medical Day Care Centre ( Site 0408) - Wollongong
Recruitment hospital [3] 0 0
Royal Brisbane and Women s Hospital ( Site 0407) - Herston
Recruitment hospital [4] 0 0
Princess Alexandra Hospital ( Site 0405) - Woolloongabba
Recruitment hospital [5] 0 0
The Townsville Hospital ( Site 0404) - Douglas
Recruitment hospital [6] 0 0
Lismore Base Hospital ( Site 0402) - Lismore
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
2480 - Lismore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
New Brunswick
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Cedex 9
Country [17] 0 0
France
State/province [17] 0 0
Bobigny
Country [18] 0 0
France
State/province [18] 0 0
Lille
Country [19] 0 0
France
State/province [19] 0 0
Limoges
Country [20] 0 0
France
State/province [20] 0 0
Marseille
Country [21] 0 0
France
State/province [21] 0 0
Nice cedex 3
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Pierre Benite
Country [24] 0 0
France
State/province [24] 0 0
Reims
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Hannover
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Mannheim
Country [30] 0 0
Germany
State/province [30] 0 0
Tuebingen
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Petah Tikva
Country [33] 0 0
Israel
State/province [33] 0 0
Ramat Gan
Country [34] 0 0
Israel
State/province [34] 0 0
Tel-Aviv
Country [35] 0 0
Mexico
State/province [35] 0 0
Jalisco
Country [36] 0 0
Mexico
State/province [36] 0 0
Nuevo Leon
Country [37] 0 0
Mexico
State/province [37] 0 0
Chihuahua
Country [38] 0 0
Mexico
State/province [38] 0 0
Mexico City
Country [39] 0 0
Norway
State/province [39] 0 0
Bergen
Country [40] 0 0
Norway
State/province [40] 0 0
Oslo
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Valencia
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Wirral
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O,... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03284424