COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03284424
Ethics application status
Date submitted
14/09/2017
Date registered
15/09/2017
Date last updated
24/03/2020

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
2017-000594-37
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
Other interventions - 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.


Other interventions: Pembrolizumab
IV infusion

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) - 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).
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [1] 0 0
Duration of Response (DOR) - For participants who demonstrate a CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), DOR is defined as the time from first documented evidence of CR or PR per RECIST 1.1 as assessed by BICR until 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 PD.) per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR) - DCR is defined as the percentage of participants who have CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) 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 and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.]) for at least 12 weeks per RECIST 1.1 as assessed by BICR.
Timepoint [2] 0 0
Up to approximately 24 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS) - PFS is defined as the time from first day of study treatment to the first documented 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 PD.] per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.
Timepoint [3] 0 0
Up to approximately 24 months
Secondary outcome [4] 0 0
Overall Survival (OS) - OS is defined as the time from first day of study treatment to death due to any cause.
Timepoint [4] 0 0
Up to approximately 24 months
Secondary outcome [5] 0 0
Adverse Events (AEs) - 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.
Timepoint [5] 0 0
Up to approximately 27 months
Secondary outcome [6] 0 0
Study Treatment Discontinuations Due to AEs - 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.
Timepoint [6] 0 0
Up to approximately 24 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, radiation, or systemic therapy.

- 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 unless the lesion has grown since receiving the 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, radiotherapy, or systemic therapy), and is not amenable
to either curative surgery, radiotherapy, or concurrent chemoradiotherapy treatment.

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has cSCC that is amenable to surgical resection, local control with radiotherapy, or
local control with a combination of surgery and radiotherapy, or chemoradiotherapy.

- 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 Corp.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03284424
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
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

Summary results
Other publications