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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03833167




Registration number
NCT03833167
Ethics application status
Date submitted
4/02/2019
Date registered
6/02/2019

Titles & IDs
Public title
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Secondary ID [1] 0 0
MK-3475-630
Secondary ID [2] 0 0
3475-630
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Squamous Cell 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 400 mg
Treatment: Drugs - Placebo

Experimental: Pembrolizumab - Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.

Placebo comparator: Placebo - Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.


Treatment: Other: Pembrolizumab 400 mg
Administered by IV infusion on Day 1 of each 42-day cycle

Treatment: Drugs: Placebo
Administered by IV infusion on Day 1 of each 42-day cycle
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
Timepoint [1] 0 0
Up to approximately 60 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 60 months
Secondary outcome [2] 0 0
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Timepoint [2] 0 0
Baseline and up to approximately 60 months
Secondary outcome [3] 0 0
Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score
Timepoint [3] 0 0
Baseline and up to approximately 60 months
Secondary outcome [4] 0 0
Percentage of Participants Who Experience an Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 63 months
Secondary outcome [5] 0 0
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [5] 0 0
Up to approximately 38 months

Eligibility
Key inclusion criteria
* Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted)
* Has histologically confirmed LA cSCC with =1 high-risk feature(s) as the primary site of malignancy
* Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided
* Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT =4 weeks and =16 weeks from randomization
* Has received an adequate post-op dose of RT (either hypofractionated or conventional)
* Is disease free as assessed by the investigator with complete radiographic staging assessment =28 days from randomization
* Is not pregnant or breastfeeding
* Is not a person of childbearing potential (POCBP)
* Has a negative pregnancy test =72 hours before the first dose of study intervention.
* Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
* Has a life expectancy of >3 months
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 =10 days prior to the first dose of study intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
* Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma
* Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another costimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
* Has received prior systemic anticancer therapy including investigational agents for cSCC =4 weeks prior to before start of study intervention.
* Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis
* Has received a live vaccine =30 days prior to the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Other exceptions may be considered with Sponsor consultation. Note: Participants with low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or T2a with a Gleason score =6 and a prostate-specific antigen (=10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation. Early stage asymptomatic CLL without prior treatment and without any of the risk features (unmutated IGHV, lymphocytes >15,000µL, palpable lymph nodes) will be eligible for the study
* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) 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 intervention
* Has had an allogeneic tissue/solid organ transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/09/2028
Actual
Sample size
Target
430
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse ( Site 0051) - Camperdown
Recruitment hospital [2] 0 0
Lismore Base Hospital ( Site 0050) - Lismore
Recruitment hospital [3] 0 0
Orange Health Services ( Site 0053) - Orange
Recruitment hospital [4] 0 0
Royal North Shore Hospital ( Site 0052) - St Leonards
Recruitment hospital [5] 0 0
Gold Coast University Hospital ( Site 0054) - Southport
Recruitment hospital [6] 0 0
Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056) - Sunshine Coast
Recruitment hospital [7] 0 0
Alfred Health ( Site 0055) - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2800 - Orange
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4575 - Sunshine Coast
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
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Kentucky
Country [10] 0 0
United States of America
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Massachusetts
Country [11] 0 0
United States of America
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New Jersey
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United States of America
State/province [12] 0 0
New York
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Argentina
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Caba
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Argentina
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La Rioja
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Argentina
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Santiago del Estero
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Brazil
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Ceara
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Brazil
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Parana
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Brazil
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Rio Grande Do Sul
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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Chile
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Antofagasta
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Colombia
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Cordoba
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Colombia
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Distrito Capital De Bogota
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Colombia
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Risaralda
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Santander
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Colombia
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Valle Del Cauca
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France
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Alpes-Maritimes
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France
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Bouches-du-Rhone
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Calvados
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Doubs
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Drome
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Gard
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Gironde
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Herault
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Nord
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Puy-de-Dome
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Rhone
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Seine-Saint-Denis
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Val-de-Marne
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Vienne
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Greece
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Achaia
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Greece
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Attiki
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Greece
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Thessaloniki
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Hungary
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Baranya
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Hungary
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Csongrad
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Hungary
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Szabolcs-Szatmar-Bereg
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Hungary
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Vas
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Hungary
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Budapest
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Ireland
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Dublin
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petah Tiqwa
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Israel
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Ramat Gan
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Israel
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Tel-Aviv
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Italy
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Puglia
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Italy
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Toscana
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Italy
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Milano
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Italy
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Napoli
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Mexico
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Chiapas
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Mexico
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Coahuila
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Mexico
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Jalisco
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Mexico
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Yucatan
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Mexico
State/province [91] 0 0
Chihuahua
Country [92] 0 0
Mexico
State/province [92] 0 0
Veracruz
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New Zealand
State/province [93] 0 0
Auckland
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Norway
State/province [94] 0 0
Hordaland
Country [95] 0 0
Norway
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Sor-Trondelag
Country [96] 0 0
Norway
State/province [96] 0 0
Oslo
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Poland
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Malopolskie
Country [98] 0 0
Poland
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Mazowieckie
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Poland
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Pomorskie
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Poland
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Slaskie
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Portugal
State/province [101] 0 0
Faro
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Bihor
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Romania
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Bucuresti
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Romania
State/province [106] 0 0
Cluj
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Romania
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Dolj
Country [108] 0 0
Romania
State/province [108] 0 0
Timis
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Russian Federation
State/province [109] 0 0
Altayskiy Kray
Country [110] 0 0
Russian Federation
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Baskortostan, Respublika
Country [111] 0 0
Russian Federation
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Kaluzskaja Oblast
Country [112] 0 0
Russian Federation
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Krasnodarskiy Kray
Country [113] 0 0
Russian Federation
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Moskovskaya Oblast
Country [114] 0 0
Russian Federation
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Moskva
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Russian Federation
State/province [115] 0 0
Nizhegorodskaya Oblast
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Sankt-Peterburg
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Udmurtskaya Respublika
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Yaroslavskaya Oblast
Country [119] 0 0
Spain
State/province [119] 0 0
Barcelona
Country [120] 0 0
Spain
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Cantabria
Country [121] 0 0
Spain
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Cataluna
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Spain
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Gipuzkoa
Country [123] 0 0
Spain
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Madrid
Country [124] 0 0
Spain
State/province [124] 0 0
Malaga
Country [125] 0 0
Ukraine
State/province [125] 0 0
Ivano-Frankivska Oblast
Country [126] 0 0
Ukraine
State/province [126] 0 0
Kharkivska Oblast
Country [127] 0 0
Ukraine
State/province [127] 0 0
Kirovohradska Oblast
Country [128] 0 0
Ukraine
State/province [128] 0 0
Sumska Oblast
Country [129] 0 0
Ukraine
State/province [129] 0 0
Kyiv
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Cornwall
Country [131] 0 0
United Kingdom
State/province [131] 0 0
London, City Of
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Oxfordshire

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03833167