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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04895358




Registration number
NCT04895358
Ethics application status
Date submitted
17/05/2021
Date registered
20/05/2021

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
Secondary ID [1] 0 0
MK-3475-B49
Secondary ID [2] 0 0
3475-B49
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - pembrolizumab
Treatment: Drugs - paclitaxel
Treatment: Drugs - nab-paclitaxel
Treatment: Drugs - liposomal doxorubicin
Treatment: Drugs - capecitabine
Treatment: Drugs - normal saline
Treatment: Drugs - dextrose

Experimental: Pembrolizumab + Chemotherapy - Participants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.

Active comparator: Placebo + Chemotherapy - Participants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 PO BID on Days 1-14 Q3W for up to 35 administrations.


Treatment: Other: pembrolizumab
Intravenous (IV) infusion

Treatment: Drugs: paclitaxel
IV infusion

Treatment: Drugs: nab-paclitaxel
IV infusion

Treatment: Drugs: liposomal doxorubicin
IV infusion

Treatment: Drugs: capecitabine
oral administration

Treatment: Drugs: normal saline
IV infusion

Treatment: Drugs: dextrose
IV infusion
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 (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1
Timepoint [1] 0 0
Up to approximately 50 months
Secondary outcome [1] 0 0
Overall Survival (OS) in Participants With Combined Positive Score (CPS) =1
Timepoint [1] 0 0
Up to approximately 76 months
Secondary outcome [2] 0 0
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10
Timepoint [2] 0 0
Up to approximately 76 months
Secondary outcome [3] 0 0
OS in Participants With CPS =10
Timepoint [3] 0 0
Up to approximately 76 months
Secondary outcome [4] 0 0
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) =10
Timepoint [4] 0 0
Up to approximately 76 months
Secondary outcome [5] 0 0
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) =1
Timepoint [5] 0 0
Up to approximately 76 months
Secondary outcome [6] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10
Timepoint [6] 0 0
Up to approximately 76 months
Secondary outcome [7] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1
Timepoint [7] 0 0
Up to approximately 76 months
Secondary outcome [8] 0 0
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10
Timepoint [8] 0 0
Up to approximately 76 months
Secondary outcome [9] 0 0
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1
Timepoint [9] 0 0
Up to approximately 76 months
Secondary outcome [10] 0 0
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10
Timepoint [10] 0 0
Up to approximately 76 months
Secondary outcome [11] 0 0
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1
Timepoint [11] 0 0
Up to approximately 76 months
Secondary outcome [12] 0 0
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [12] 0 0
Baseline and up to approximately 76 months
Secondary outcome [13] 0 0
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [13] 0 0
Baseline and up to approximately 76 months
Secondary outcome [14] 0 0
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [14] 0 0
Baseline and up to approximately 76 months
Secondary outcome [15] 0 0
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [15] 0 0
Baseline and up to approximately 76 months
Secondary outcome [16] 0 0
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [16] 0 0
Baseline and up to approximately 76 months
Secondary outcome [17] 0 0
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [17] 0 0
Baseline and up to approximately 76 months
Secondary outcome [18] 0 0
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [18] 0 0
Baseline and up to approximately 76 months
Secondary outcome [19] 0 0
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [19] 0 0
Baseline and up to approximately 76 months
Secondary outcome [20] 0 0
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [20] 0 0
Baseline and up to approximately 76 months
Secondary outcome [21] 0 0
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [21] 0 0
Baseline and up to approximately 76 months
Secondary outcome [22] 0 0
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [22] 0 0
Up to approximately 76 months
Secondary outcome [23] 0 0
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [23] 0 0
Up to approximately 76 months
Secondary outcome [24] 0 0
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [24] 0 0
Up to approximately 76 months
Secondary outcome [25] 0 0
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [25] 0 0
Up to approximately 76 months
Secondary outcome [26] 0 0
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [26] 0 0
Up to approximately 76 months
Secondary outcome [27] 0 0
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [27] 0 0
Up to approximately 76 months
Secondary outcome [28] 0 0
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [28] 0 0
Up to approximately 76 months
Secondary outcome [29] 0 0
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10
Timepoint [29] 0 0
Up to approximately 76 months
Secondary outcome [30] 0 0
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [30] 0 0
Up to approximately 76 months
Secondary outcome [31] 0 0
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1
Timepoint [31] 0 0
Up to approximately 76 months
Secondary outcome [32] 0 0
Percentage of Participants who Experience an Adverse Event (AE)
Timepoint [32] 0 0
Up to approximately 76 months
Secondary outcome [33] 0 0
Percentage of Participants who Discontinue Study Drug due to an AE
Timepoint [33] 0 0
Up to approximately 76 months

Eligibility
Key inclusion criteria
The key inclusion and exclusion criteria include but are not limited to the following:



* Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
* Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
* Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
* GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
* GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease. OR
* GROUP 3: If no prior treatment with a CDK4/6 inhibitor, for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy.
* Has presented a documented radiographic disease progression (as assessed by the investigator and/or histology [biopsy or cytology] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study.
* Is a chemotherapy candidate that meets the criteria specified in the protocol
* Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated
* Has centrally confirmed PD-L1 CPS =1 and HR+ (estrogen receptor [ER] and/or progesterone receptor [PgR]) /HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/(College of American Pathologists) CAP guidelines on most recent tumor biopsy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment
* Has adequate organ function within 10 days prior to the start of study
* Male participants must agree to the following during the treatment period and for at least 6 months after the last dose of chemotherapy: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception and agree to use a male condom plus partner use of an additional contraceptive
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab and 180 days after the last dose of chemotherapy (whichever occurs last), AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention
* Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist
* If receiving bisphosphonates or RANK ligand inhibitors, with stable doses for =4 weeks prior to the date of randomization, the participant may continue receiving this therapy during the study treatment. If participant needs to initiate these agents during the screening period, a bone scan to evaluate bone disease should be performed prior to randomization.
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization
* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has breast cancer amenable to treatment with curative intent
* Has a history or current evidence of any condition (e.g., transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator
* Has significant cardiac disease, such as: history of myocardial infarction, acute coronary syndrome, coronary angioplasty/stenting/bypass within the last 6 months, congestive heart failure (CHF) New York Heart association (NYHA) Class II-IV, or history of CHF NYHA Class III or IV
* Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, shortness of breath requiring supplemental oxygen, symptomatic pleural effusion requiring supplemental oxygen, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control
* Has skin only disease
* Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition. either in the adjuvant or metastatic setting (where available and not medically contraindicated). Single-agent PARP inhibitor therapy does not count as a line of endocrine therapy.
* Has received prior chemotherapy for locally recurrent inoperable or metastatic breast cancer
* Has received prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death ligand 1 (PD-L1), or anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
* Has received prior systemic anticancer therapy with other investigational agents within 4 weeks prior to randomization
* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
* Has received a live or live attenuated vaccine within 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 study intervention
* 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
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ excluding cancer in situ of bladder that have undergone potentially curative therapy
* Has known active central nervous system (CNS) metastases
* Has diagnosed carcinomatous meningitis
* Has severe hypersensitivity to pembrolizumab and/or any of its excipients or has any hypersensitivity to the planned chemotherapy agent (paclitaxel, nab-paclitaxel, liposomal doxorubicin, or capecitabine) and/or any of their excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* 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 COVID-19 infection (symptomatic or asymptomatic)
* Has a known history of active tuberculosis (TB)
* Has a known psychiatric or substance abuse disorder including alcohol or drug dependency that would interfere with the participant's ability to cooperate with the requirements of the study
* Is breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days (or longer as specified by local institutional guidelines) after the last dose of study treatment
* Has had an allogenic 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
18/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/03/2025
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 2102) - Macquarie Park
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 2101) - Westmead
Recruitment hospital [3] 0 0
Frankston Hospital-Oncology and Haematology ( Site 2103) - Frankston
Recruitment hospital [4] 0 0
Breast Cancer Research Centre-WA ( Site 2104) - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
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
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
North Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Caba
Country [27] 0 0
Argentina
State/province [27] 0 0
Santa Fe
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Argentina
State/province [29] 0 0
San Juan
Country [30] 0 0
Austria
State/province [30] 0 0
Niederosterreich
Country [31] 0 0
Austria
State/province [31] 0 0
Steiermark
Country [32] 0 0
Austria
State/province [32] 0 0
Tirol
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Austria
State/province [34] 0 0
Salzburg
Country [35] 0 0
Brazil
State/province [35] 0 0
Pernambuco
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio Grande Do Sul
Country [37] 0 0
Brazil
State/province [37] 0 0
Santa Catarina
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio de Janeiro
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Chile
State/province [42] 0 0
Araucania
Country [43] 0 0
Chile
State/province [43] 0 0
Region M. De Santiago
Country [44] 0 0
China
State/province [44] 0 0
Anhui
Country [45] 0 0
China
State/province [45] 0 0
Beijing
Country [46] 0 0
China
State/province [46] 0 0
Fujian
Country [47] 0 0
China
State/province [47] 0 0
Guangdong
Country [48] 0 0
China
State/province [48] 0 0
Guangxi
Country [49] 0 0
China
State/province [49] 0 0
Henan
Country [50] 0 0
China
State/province [50] 0 0
Hubei
Country [51] 0 0
China
State/province [51] 0 0
Hunan
Country [52] 0 0
China
State/province [52] 0 0
Jiangsu
Country [53] 0 0
China
State/province [53] 0 0
Jiangxi
Country [54] 0 0
China
State/province [54] 0 0
Jilin
Country [55] 0 0
China
State/province [55] 0 0
Shaanxi
Country [56] 0 0
China
State/province [56] 0 0
Shandong
Country [57] 0 0
China
State/province [57] 0 0
Shanghai
Country [58] 0 0
China
State/province [58] 0 0
Sichuan
Country [59] 0 0
China
State/province [59] 0 0
Tianjin
Country [60] 0 0
China
State/province [60] 0 0
Xinjiang
Country [61] 0 0
China
State/province [61] 0 0
Zhejiang
Country [62] 0 0
Colombia
State/province [62] 0 0
Antioquia
Country [63] 0 0
Colombia
State/province [63] 0 0
Atlantico
Country [64] 0 0
Colombia
State/province [64] 0 0
Cesar
Country [65] 0 0
Colombia
State/province [65] 0 0
Cordoba
Country [66] 0 0
Colombia
State/province [66] 0 0
Distrito Capital De Bogota
Country [67] 0 0
France
State/province [67] 0 0
Bouches-du-Rhone
Country [68] 0 0
France
State/province [68] 0 0
Calvados
Country [69] 0 0
France
State/province [69] 0 0
Franche-Comte
Country [70] 0 0
France
State/province [70] 0 0
Haute-Garonne
Country [71] 0 0
France
State/province [71] 0 0
Ile-de-France
Country [72] 0 0
France
State/province [72] 0 0
Languedoc-Roussillon
Country [73] 0 0
France
State/province [73] 0 0
Loire-Atlantique
Country [74] 0 0
France
State/province [74] 0 0
Maine-et-Loire
Country [75] 0 0
France
State/province [75] 0 0
Nord
Country [76] 0 0
France
State/province [76] 0 0
Puy-de-Dome
Country [77] 0 0
France
State/province [77] 0 0
Rhone-Alpes
Country [78] 0 0
France
State/province [78] 0 0
Seine-Maritime
Country [79] 0 0
France
State/province [79] 0 0
Vienne
Country [80] 0 0
France
State/province [80] 0 0
Paris
Country [81] 0 0
Germany
State/province [81] 0 0
Bayern
Country [82] 0 0
Germany
State/province [82] 0 0
Nordrhein-Westfalen
Country [83] 0 0
Germany
State/province [83] 0 0
Sachsen
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Greece
State/province [85] 0 0
Attiki
Country [86] 0 0
Greece
State/province [86] 0 0
Irakleio
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Greece
State/province [87] 0 0
Thessaloniki
Country [88] 0 0
Guatemala
State/province [88] 0 0
Guatemala
Country [89] 0 0
Guatemala
State/province [89] 0 0
Quetzaltenango
Country [90] 0 0
Hungary
State/province [90] 0 0
Bacs-Kiskun
Country [91] 0 0
Hungary
State/province [91] 0 0
Baranya
Country [92] 0 0
Hungary
State/province [92] 0 0
Csongrad
Country [93] 0 0
Ireland
State/province [93] 0 0
Dublin
Country [94] 0 0
Israel
State/province [94] 0 0
Ashdod
Country [95] 0 0
Israel
State/province [95] 0 0
Be'er Sheva
Country [96] 0 0
Israel
State/province [96] 0 0
Haifa
Country [97] 0 0
Israel
State/province [97] 0 0
Ramat Gan
Country [98] 0 0
Israel
State/province [98] 0 0
Tel Aviv
Country [99] 0 0
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State/province [99] 0 0
Lazio
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Italy
State/province [100] 0 0
Lombardia
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State/province [101] 0 0
Milano
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Italy
State/province [102] 0 0
Bari
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Italy
State/province [103] 0 0
Catania
Country [104] 0 0
Italy
State/province [104] 0 0
Napoli
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Italy
State/province [105] 0 0
Padova
Country [106] 0 0
Japan
State/province [106] 0 0
Hyogo
Country [107] 0 0
Japan
State/province [107] 0 0
Kanagawa
Country [108] 0 0
Japan
State/province [108] 0 0
Osaka
Country [109] 0 0
Japan
State/province [109] 0 0
Saitama
Country [110] 0 0
Japan
State/province [110] 0 0
Tokyo
Country [111] 0 0
Japan
State/province [111] 0 0
Chiba
Country [112] 0 0
Japan
State/province [112] 0 0
Fukuoka
Country [113] 0 0
Japan
State/province [113] 0 0
Fukushima
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Japan
State/province [114] 0 0
Kumamoto
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Korea, Republic of
State/province [115] 0 0
Kyonggi-do
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Korea, Republic of
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Seoul
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Kuala Lumpur
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Malaysia
State/province [118] 0 0
Pulau Pinang
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Malaysia
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State/province [120] 0 0
Distrito Federal
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Mexico
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Jalisco
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Mexico
State/province [122] 0 0
Nuevo Leon
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Mexico
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Chihuahua
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Mexico
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Oaxaca
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Netherlands
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Gelderland
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Netherlands
State/province [126] 0 0
Limburg
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Noord-Brabant
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Noord-Holland
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Netherlands
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Utrecht
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National Capital Region
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Poland
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Kujawsko-pomorskie
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Poland
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Poland
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Poland
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Podkarpackie
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Poland
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Poland
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Porto
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Dolj
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Romania
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Maramures
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Romania
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Suceava
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Arkhangel Skaya Oblast
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Russian Federation
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Russian Federation
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Stockholms Lan
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Izmir
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Turkey
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Istanbul
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Turkey
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Malatya
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United Kingdom
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Cornwall
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United Kingdom
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England
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United Kingdom
State/province [165] 0 0
Lancashire
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United Kingdom
State/province [166] 0 0
London, City Of

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/NCT04895358