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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04624204




Registration number
NCT04624204
Ethics application status
Date submitted
5/11/2020
Date registered
10/11/2020

Titles & IDs
Public title
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
Secondary ID [1] 0 0
MK-7339-013
Secondary ID [2] 0 0
7339-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab 200 mg
Treatment: Other - Pembrolizumab 400 mg
Treatment: Drugs - Pembrolizumab placebo (saline)
Treatment: Drugs - Pembrolizumab placebo (saline)
Treatment: Drugs - Olaparib 300 mg BID
Treatment: Drugs - Olaparib matching placebo
Treatment: Drugs - Etoposide 100 mg/m^2
Treatment: Drugs - Platinum, investigator's choice
Treatment: Other - Standard Thoracic Radiotherapy
Treatment: Other - Prophylactic Cranial Irradiation (PCI)

Experimental: Group A - Pembrolizumab 200 mg - Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.

Experimental: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID - Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.

Placebo comparator: Group C (Pembrolizumab and Olaparib Matching Placebos) - Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.


Treatment: Other: Pembrolizumab 200 mg
Pembrolizumab 200 mg Q3W

Treatment: Other: Pembrolizumab 400 mg
Pembrolizumab 400 mg Q6W

Treatment: Drugs: Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline) Q3W

Treatment: Drugs: Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline) Q6W

Treatment: Drugs: Olaparib 300 mg BID
Olaparib 300 mg twice daily (BID)

Treatment: Drugs: Olaparib matching placebo
Olaparib matching placebo BID

Treatment: Drugs: Etoposide 100 mg/m^2
Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3

Treatment: Drugs: Platinum, investigator's choice
Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle

Treatment: Other: Standard Thoracic Radiotherapy
Standard Thoracic Radiotherapy

Treatment: Other: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
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
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
Timepoint [1] 0 0
Up to approximately 59 months
Primary outcome [2] 0 0
Overall Survival: the time from randomization to death due to any cause
Timepoint [2] 0 0
Up to approximately 82 months
Secondary outcome [1] 0 0
Number of Participants Experiencing an Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 82 months
Secondary outcome [2] 0 0
Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately 82 months
Secondary outcome [3] 0 0
Objective Response (OR): Complete Response (CR) or Partial Response (PR)
Timepoint [3] 0 0
Up to approximately 82 months
Secondary outcome [4] 0 0
Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first
Timepoint [4] 0 0
Up to approximately 82 months
Secondary outcome [5] 0 0
Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
Timepoint [5] 0 0
Baseline and 82 months post randomization
Secondary outcome [6] 0 0
Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Timepoint [6] 0 0
Baseline and 82 months post randomization
Secondary outcome [7] 0 0
Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
Timepoint [7] 0 0
Baseline and 82 months post randomization
Secondary outcome [8] 0 0
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Timepoint [8] 0 0
Baseline and 82 months post randomization
Secondary outcome [9] 0 0
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Timepoint [9] 0 0
Baseline and 82 months post randomization
Secondary outcome [10] 0 0
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
Timepoint [10] 0 0
Up to approximately 82 months post randomization
Secondary outcome [11] 0 0
Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score
Timepoint [11] 0 0
Up to approximately 82 months post randomization
Secondary outcome [12] 0 0
Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score
Timepoint [12] 0 0
Up to approximately 82 months post randomization
Secondary outcome [13] 0 0
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Timepoint [13] 0 0
Up to approximately 82 months post randomization
Secondary outcome [14] 0 0
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Timepoint [14] 0 0
Up to approximately 82 months post randomization
Secondary outcome [15] 0 0
Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Timepoint [15] 0 0
Up to approximately 82 months
Secondary outcome [16] 0 0
Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Timepoint [16] 0 0
Up to approximately 82 months
Secondary outcome [17] 0 0
Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Timepoint [17] 0 0
Up to approximately 59 months
Secondary outcome [18] 0 0
Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Timepoint [18] 0 0
Up to approximately 82 months

Eligibility
Key inclusion criteria
1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).

Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
6. Is not expected to require tumor resection during the course of the study.
7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
9. Has a life expectancy of at least 6 months.
10. Has adequate organ function.
11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
12. Male and female participants who are at least 18 years of age at the time of signing the information consent.
13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:

* Pembrolizumab: 120 days
* Olaparib: 7 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
4. Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
5. 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 intervention.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
8. Has severe hypersensitivity (= Grade 3) to study intervention and/or any of its excipients.
9. Has an active autoimmune disease that has required systemic treatment in past 2 years
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
11. Has an active infection requiring systemic therapy.
12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

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 assessing the outcomes
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
8/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2027
Actual
Sample size
Target
672
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Campbelltown Hospital ( Site 3002) - Campbelltown
Recruitment hospital [2] 0 0
Nepean Hospital ( Site 3001) - Kingswood
Recruitment hospital [3] 0 0
Calvary Mater Newcastle ( Site 3000) - Waratah
Recruitment hospital [4] 0 0
Gold Coast University Hospital ( Site 3003) - Southport
Recruitment hospital [5] 0 0
Frankston Hospital-Oncology and Haematology ( Site 3007) - Frankston
Recruitment hospital [6] 0 0
Austin Health-Austin Hospital ( Site 3006) - Heidelberg
Recruitment hospital [7] 0 0
Western Health-Sunshine Hospital ( Site 3004) - St Albans
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
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Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles-Capitale, Region De
Country [22] 0 0
Belgium
State/province [22] 0 0
Hainaut
Country [23] 0 0
Belgium
State/province [23] 0 0
Namur
Country [24] 0 0
Belgium
State/province [24] 0 0
Vlaams-Brabant
Country [25] 0 0
Belgium
State/province [25] 0 0
West-Vlaanderen
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pazardzhik
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
China
State/province [30] 0 0
Beijing
Country [31] 0 0
China
State/province [31] 0 0
Chongqing
Country [32] 0 0
China
State/province [32] 0 0
Fujian
Country [33] 0 0
China
State/province [33] 0 0
Guangdong
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China
State/province [34] 0 0
Henan
Country [35] 0 0
China
State/province [35] 0 0
Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shandong
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China
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Shanghai
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China
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Sichuan
Country [43] 0 0
China
State/province [43] 0 0
Tianjin
Country [44] 0 0
China
State/province [44] 0 0
Zhejiang
Country [45] 0 0
Estonia
State/province [45] 0 0
Harjumaa
Country [46] 0 0
Estonia
State/province [46] 0 0
Tartumaa
Country [47] 0 0
France
State/province [47] 0 0
Aisne
Country [48] 0 0
France
State/province [48] 0 0
Aquitaine
Country [49] 0 0
France
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Bouches-du-Rhone
Country [50] 0 0
France
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Ile-de-France
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France
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Isere
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France
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Loire-Atlantique
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France
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Maine-et-Loire
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France
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Seine-Saint-Denis
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France
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Var
Country [56] 0 0
Greece
State/province [56] 0 0
Attiki
Country [57] 0 0
Greece
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Irakleio
Country [58] 0 0
Greece
State/province [58] 0 0
Kentriki Makedonia
Country [59] 0 0
Greece
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Thessalia
Country [60] 0 0
Hungary
State/province [60] 0 0
Bacs-Kiskun
Country [61] 0 0
Hungary
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Gyor-Moson-Sopron
Country [62] 0 0
Hungary
State/province [62] 0 0
Pest
Country [63] 0 0
Hungary
State/province [63] 0 0
Budapest
Country [64] 0 0
Israel
State/province [64] 0 0
Haifa
Country [65] 0 0
Israel
State/province [65] 0 0
Ramat Gan
Country [66] 0 0
Italy
State/province [66] 0 0
Emilia-Romagna
Country [67] 0 0
Italy
State/province [67] 0 0
Firenze
Country [68] 0 0
Italy
State/province [68] 0 0
Veneto
Country [69] 0 0
Italy
State/province [69] 0 0
Brescia
Country [70] 0 0
Italy
State/province [70] 0 0
Milano
Country [71] 0 0
Italy
State/province [71] 0 0
Padova
Country [72] 0 0
Italy
State/province [72] 0 0
Roma
Country [73] 0 0
Japan
State/province [73] 0 0
Aichi
Country [74] 0 0
Japan
State/province [74] 0 0
Hyogo
Country [75] 0 0
Japan
State/province [75] 0 0
Kanagawa
Country [76] 0 0
Japan
State/province [76] 0 0
Osaka
Country [77] 0 0
Japan
State/province [77] 0 0
Shizuoka
Country [78] 0 0
Japan
State/province [78] 0 0
Fukuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Niigata
Country [80] 0 0
Japan
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Okayama
Country [81] 0 0
Japan
State/province [81] 0 0
Tokyo
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Kyonggi-do
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Pusan-Kwangyokshi
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Taegu-Kwangyokshi
Country [86] 0 0
Lithuania
State/province [86] 0 0
Vilniaus Miestas
Country [87] 0 0
Lithuania
State/province [87] 0 0
Kaunas
Country [88] 0 0
Mexico
State/province [88] 0 0
Jalisco
Country [89] 0 0
Mexico
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Nuevo Leon
Country [90] 0 0
Portugal
State/province [90] 0 0
Lisboa
Country [91] 0 0
Portugal
State/province [91] 0 0
Porto
Country [92] 0 0
Romania
State/province [92] 0 0
Cluj
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Romania
State/province [93] 0 0
Prahova
Country [94] 0 0
Romania
State/province [94] 0 0
Timis
Country [95] 0 0
Romania
State/province [95] 0 0
Bucuresti
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moskovskaya Oblast
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Moskva
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Nizhegorodskaya Oblast
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Omskaya Oblast
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Sverdlovskaya Oblast
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Tatarstan, Respublika
Country [102] 0 0
Serbia
State/province [102] 0 0
Beograd
Country [103] 0 0
Serbia
State/province [103] 0 0
Sremski Okrug
Country [104] 0 0
South Africa
State/province [104] 0 0
Gauteng
Country [105] 0 0
South Africa
State/province [105] 0 0
Western Cape
Country [106] 0 0
Spain
State/province [106] 0 0
Asturias
Country [107] 0 0
Spain
State/province [107] 0 0
Barcelona
Country [108] 0 0
Spain
State/province [108] 0 0
Madrid
Country [109] 0 0
Spain
State/province [109] 0 0
Malaga
Country [110] 0 0
Spain
State/province [110] 0 0
Sevilla
Country [111] 0 0
Turkey
State/province [111] 0 0
Ankara
Country [112] 0 0
Turkey
State/province [112] 0 0
Istanbul
Country [113] 0 0
Turkey
State/province [113] 0 0
Izmir
Country [114] 0 0
Ukraine
State/province [114] 0 0
Dnipropetrovska Oblast
Country [115] 0 0
Ukraine
State/province [115] 0 0
Kharkivska Oblast
Country [116] 0 0
Ukraine
State/province [116] 0 0
Khmelnytska Oblast
Country [117] 0 0
Ukraine
State/province [117] 0 0
Kyivska Oblast
Country [118] 0 0
Ukraine
State/province [118] 0 0
Kyiv
Country [119] 0 0
Ukraine
State/province [119] 0 0
Vinnytska Oblast
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Aberdeen City
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Dundee City
Country [122] 0 0
United Kingdom
State/province [122] 0 0
England
Country [123] 0 0
United Kingdom
State/province [123] 0 0
London, City Of
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Manchester

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, MD
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
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
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/NCT04624204