DREAMM-3: Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04162210
Collaborator
(none)
380
164
2
59.8
2.3
0

Study Details

Study Description

Brief Summary

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

Condition or Disease Intervention/Treatment Phase
  • Drug: Belantamab mafodotin
  • Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
380 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is an open-label, randomized and multi-center studyThis is an open-label, randomized and multi-center study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)
Actual Study Start Date :
Apr 2, 2020
Anticipated Primary Completion Date :
Aug 22, 2022
Anticipated Study Completion Date :
Mar 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants receiving Belantamab mafodotin

Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W

Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.

Active Comparator: Participants receiving pom/dex

Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.

Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)
Pomalidomide and Dexamethasone will be administered.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [Up to 25 months]

    PFS is defined as the time from the date of randomization until the earliest date of documented disease progression (according to International Myeloma Working Group [IMWG] Response Criteria) or death due to any cause.

Secondary Outcome Measures

  1. Overall survival (OS) [60 months]

    OS is defined as the time from randomization until death due to any cause.

  2. Overall response rate (ORR) [Up to 55 months]

    ORR is defined as the percentage of participants with a confirmed partial response (PR) or better per IMWG.

  3. Clinical benefit rate (CBR) [Up to 55 months]

    CBR is defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG.

  4. Duration of response (DoR) [Up to 55 months]

    DoR is defined as the time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to PD among participants who achieve confirmed PR or better.

  5. Time to response (TTR) [Up to 55 months]

    TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

  6. Time to progression (TTP) [Up to 55 months]

    TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.

  7. Number of participants with adverse events (AEs) [Up to 55 months]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

  8. Change from Baseline in hematology parameters: absolute white blood cell count (WBC), basophils,eosinophils, lymphocytes, monocytes, platelet count, and neutrophils (Giga cells per liter) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of hematology parameters.

  9. Change from Baseline in hematology parameters: Red Blood Cell (RBC) count and reticulocyte count (Trillion cells per liter) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of hematology parameters.

  10. Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin concentration (MCHC) and hemoglobin (Grams per Liter) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of hematology parameters.

  11. Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of hematology parameters.

  12. Change from Baseline in hematology parameters: Mean Corpuscular Volume (MCV) [Femtoliter] [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of hematology parameters.

  13. Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin (MCH) [Picograms] [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of hematology parameters.

  14. Change from Baseline in clinical chemistry parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine kinase (CK), Gamma Glutamyl Transferase (GGT), and lactate dehydrogenase (LDH) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of clinical chemistry parameters like ALT, AST, ALP, CK, GGT, and LDH [International units per Liter].

  15. Change from Baseline in clinical chemistry parameters: Calcium, chloride, glucose, potassium, sodium, magnesium, blood urea nitrogen (BUN), and phosphorous (Millimoles per Liter) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of clinical chemistry parameters.

  16. Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (Micromoles per liter) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of clinical chemistry parameters.

  17. Change from Baseline in clinical chemistry parameters: Albumin and total protein (Grams per Liter) [Baseline and up to 55 months]

    Blood samples will be collected for the analysis of clinical chemistry parameters.

  18. Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

  19. Change from Baseline in Urinalysis Parameters- Urine potential of hydrogen (pH) (Points on a scale) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

  20. Change from Baseline in urinalysis parameter: Glucose (Millimole per liter) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of urinary glucose.

  21. Change from Baseline in urinalysis parameter: Protein (Grams per liter) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of urinary protein.

  22. Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of urinary ketones.

  23. Change from Baseline in urinalysis parameter: blood (10^9 cells per liter) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of urinary blood.

  24. Change from Baseline in urinalysis parameter: creatinine/albumin ratio (ratio) [Baseline and up to 55 months]

    Urine samples will be collected for the assessment of urinary creatinine/albumin ratio.

  25. Number of participants with abnormal ocular findings [Up to 55 months]

    Participants will be assessed for any abnormal ocular findings.

  26. Plasma concentrations of belantamab mafodotin [Up to 55 months]

    Blood samples will be collected for the analysis.

  27. Plasma concentrations of total monoclonal antibody (mAb) [Up to 55 months]

    Blood samples will be collected for the analysis.

  28. Plasma concentrations of cys-mc Microtubular inhibitor monomethyl auristatin-F (MMAF) [Up to 55 months]

    Blood samples will be collected for the analysis.

  29. Number of participants with Anti-drug antibody (ADAs) against belantamab mafodotin [Up to 55 months]

    Blood samples will be collected for the analysis.

  30. Titer of ADAs against belantamab mafodotin [Up to 55 months]

    Blood samples will be collected for the analysis.

  31. Number of participants with symptomatic adverse effects measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Up to 55 months]

    PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.

  32. Number of participants with symptomatic adverse effects measured by Ocular Surface Disease Index (OSDI) [Up to 55 months]

    OSDI is a 12-item questionnaire designed to assesses both the frequency of dry eye symptoms and their impact on vision-related functioning. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. A higher score represents greater symptoms severity.

  33. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQC30) score [Up to 55 months]

    The EORTC QLQ-C30 is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/quality of life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure are averaged and transformed linearly to a score ranging from 0-100.

  34. European Organization for Research and Treatment of Cancer IL52 (EORTC IL52) score [Up to 55 months]

    The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning.

  35. EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) Score [Up to 55 months]

    The EORTC QLQMY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. It includes four scales (Disease Symptoms, Body Image, Future Perspective, and Side Effects). The domain scores are averaged and transformed linearly to a score ranging from 0 to 100. A high score represents a high level of symptomatology or problems.

  36. Rate of Minimal Residual Disease (MRD) [Up to 55 months]

    MRD negativity rate, defined as; the percentage of participants who are MRD negative by Next generation sequencing (NGS) method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Capable of giving signed informed consent.

  • Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

  • Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT), or is considered transplant ineligible; Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination), and must have documented disease progression on, or within 60 days of, completion of the last treatment or must be non-responsive while on last treatment, where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 complete treatment cycles. In such cases lack of achieving of at least MR must be determined no earlier than at least 4 weeks after the last treatment.

  • Has measurable disease with at least one of the following: Serum M-protein >=0.5 gram per deciliter (g/dL) (>=5 gram per Liter); Urine M-protein >=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level >=10 milligram per deciliter (mg/dL) (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).

  • Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: Transplant was >100 days prior to initiating study treatment; No active infection(s).

  • Adequate organ system functions as defined: Absolute neutrophil count (ANC)

=1.0109/L; Hemoglobin >= 8.0 g/dL; Platelets >= 50x109/L; Total bilirubin <=1.5 Upper limit of normal (ULN) (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); ALT <=2.5ULN; Estimated glomerular filtration rate (eGFR) >=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2); Spot urine (albumin/creatinine ratios) <=500 milligram per gram (mg/g) (56 milligram per millimoles [mg/mmol]).

  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of study intervention to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below depending on whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have undergone a successful vasectomy: Agree to use a male condom throughout study treatment including the 6 month follow-up period even if they have undergone a successful vasectomy and a female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent per year when having sexual intercourse with a pregnant woman or a woman of childbearing potential who is not currently pregnant. Four weeks for male participants on Treatment Arm 2 (pom/dex).

  • 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 agrees to abide by the following: Arm 1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a failure rate of <1 percent per year) which includes abstinence, preferably with low user dependency during the intervention period and for 4 months after the last dose of study treatment. Arm 2 (pom/dex): Due to pomalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective), beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing pomalidomide therapy. And agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should confirm the effectiveness of the contraceptive method(s) ahead of the first dose of study intervention.

  • All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5.0, 2017) must be <=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.

Exclusion Criteria:
  • Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the time of screening.

  • Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 5 half-lives, whichever is shorter, before the first dose of study intervention.

  • Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving the first dose of study intervention.

  • Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide treatment.

  • Plasmapheresis within 7 days prior to the first dose of study intervention.

  • Prior allogeneic stem cell transplant. (Participants who have undergone syngeneic transplant will be allowed only if no history of, or currently active, Graft-Versus-Host Disease [GvHD]).

  • Any major surgery within the last 4 weeks.

  • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as described in inclusion criteria.

  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.

  • History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

  • Evidence of active mucosal or internal bleeding.

  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. (Stable chronic liver disease [including Gilbert's syndrome or asymptomatic gallstones] or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria)

  • Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. (Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction).

  • Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.

  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the components of the study intervention.

  • Pregnant or lactating female.

  • Active infection requiring treatment.

  • Known human immunodeficiency virus (HIV), unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/mL; CD4+ T-cell (CD4+) counts ≥350 cells/uL; No history of AIDS-defining opportunistic infections within the last 12 months.(Consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant)

  • Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undectectable at the time of screening; If HbsAg+ at screening or <=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment, exclusion of participants with cirrhosis and participants in Japan must test hepatitis B e antigen (HBeAg) and hepatitis B e antibody (HBeAb ).

  • Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: Hepatitis C RNA test negative at Screening and successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks (Hepatitis RNA is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing).

  • Participants unable to tolerate thromboembolic prophylaxis.

  • Current corneal epithelial disease except for mild punctate keratopathy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Tucson Arizona United States 85715
2 GSK Investigational Site Santa Barbara California United States 93105
3 GSK Investigational Site Pueblo Colorado United States 81008
4 GSK Investigational Site Plantation Florida United States 33322
5 GSK Investigational Site Detroit Michigan United States 48202
6 GSK Investigational Site Omaha Nebraska United States 68130
7 GSK Investigational Site Las Vegas Nevada United States 89169
8 GSK Investigational Site Albany New York United States 12208-3479
9 GSK Investigational Site Lake Success New York United States 10042
10 GSK Investigational Site Cincinnati Ohio United States 45236
11 GSK Investigational Site Eugene Oregon United States 97401
12 GSK Investigational Site Salem Oregon United States 97301
13 GSK Investigational Site Dallas Texas United States 75230
14 GSK Investigational Site Dallas Texas United States 75231
15 GSK Investigational Site Tyler Texas United States 75702
16 GSK Investigational Site Milwaukee Wisconsin United States 53226
17 GSK Investigational Site Gosford New South Wales Australia 2250
18 GSK Investigational Site Liverpool New South Wales Australia 2170
19 GSK Investigational Site St Leonards New South Wales Australia 2065
20 GSK Investigational Site Wollongong New South Wales Australia 2500
21 GSK Investigational Site North Adelaide South Australia Australia 5006
22 GSK Investigational Site Woodville South Australia Australia 5011
23 GSK Investigational Site Hobart Tasmania Australia 7000
24 GSK Investigational Site Clayton Victoria Australia 3168
25 GSK Investigational Site Fitzroy Victoria Australia 3065
26 GSK Investigational Site Geelong Victoria Australia 3220
27 GSK Investigational Site Melbourne Victoria Australia 3004
28 GSK Investigational Site Nedlands Western Australia Australia 6009
29 GSK Investigational Site St. Albans Australia 03021
30 GSK Investigational Site Brugge Belgium 8000
31 GSK Investigational Site Bruxelles Belgium 1200
32 GSK Investigational Site Edegem Belgium 2650
33 GSK Investigational Site Gent Belgium 9000
34 GSK Investigational Site Jette Belgium 1090
35 GSK Investigational Site Kortrijk Belgium 8500
36 GSK Investigational Site Yvoir Belgium 5530
37 GSK Investigational Site Fortaleza Ceará Brazil 60115-281
38 GSK Investigational Site Curitiba Paraná Brazil 80530-010
39 GSK Investigational Site Porto Alegre Rio Grande Do Sul Brazil 90035-903
40 GSK Investigational Site Porto Alegre Rio Grande Do Sul Brazil 90110-270
41 GSK Investigational Site Rio de Janeiro Brazil 21941-913
42 GSK Investigational Site Rio de Janeiro Brazil 22793-080
43 GSK Investigational Site São Paulo Brazil 01321001
44 GSK Investigational Site São Paulo Brazil 01509-900
45 GSK Investigational Site São Paulo Brazil 04537-080
46 GSK Investigational Site São Paulo Brazil 05651-901
47 GSK Investigational Site Pleven Bulgaria 5800
48 GSK Investigational Site Plovdiv Bulgaria 4000
49 GSK Investigational Site Sofia Bulgaria 01431
50 GSK Investigational Site Sofia Bulgaria 1000
51 GSK Investigational Site Sofia Bulgaria 1407
52 GSK Investigational Site Sofia Bulgaria 1606
53 GSK Investigational Site Edmonton Alberta Canada T6G 1Z2
54 GSK Investigational Site Guangzhou Guangdong China 510080
55 GSK Investigational Site Changchun Jilin China 130012
56 GSK Investigational Site Beijing China 100191
57 GSK Investigational Site Beijing China 100730
58 GSK Investigational Site Chengdu China 610041
59 GSK Investigational Site Hangzhou China 310009
60 GSK Investigational Site Tianjin China 300020
61 GSK Investigational Site Tianjin China 300060
62 GSK Investigational Site Zhengzhou China 450052
63 GSK Investigational Site Amiens cedex 1 France 80054
64 GSK Investigational Site Créteil cedex France 94010
65 GSK Investigational Site Grenoble cedex 9 France 38043
66 GSK Investigational Site Le Mans France 72015
67 GSK Investigational Site Limoges cedex France 87042
68 GSK Investigational Site Montpellier France 34295
69 GSK Investigational Site Parris Cedex 12 France 75571
70 GSK Investigational Site Poitiers cedex France 86021
71 GSK Investigational Site Tuebingen Baden-Wuerttemberg Germany 72076
72 GSK Investigational Site Ulm Baden-Wuerttemberg Germany 89081
73 GSK Investigational Site Wuerzburg Bayern Germany 97080
74 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55101
75 GSK Investigational Site Berlin Germany 13125
76 GSK Investigational Site Hamburg Germany 20246
77 GSK Investigational Site Athens Greece 10676
78 GSK Investigational Site Athens Greece 115 28
79 GSK Investigational Site Haidari, Athens Greece 12462
80 GSK Investigational Site Larisa Greece 41 110
81 GSK Investigational Site Patra Greece 26500
82 GSK Investigational Site Thessaloniki Greece 54007
83 GSK Investigational Site Thessaloniki Greece 57010
84 GSK Investigational Site Budapest Hungary 1083
85 GSK Investigational Site Budapest Hungary 1088
86 GSK Investigational Site Budapest Hungary 1097
87 GSK Investigational Site Debrecen Hungary 4012
88 GSK Investigational Site Kaposvár Hungary 7400
89 GSK Investigational Site Nyiregyhaza Hungary 4400
90 GSK Investigational Site Catanzaro Calabria Italy 88100
91 GSK Investigational Site Bologna Emilia-Romagna Italy 40138
92 GSK Investigational Site Meldola (FC) Emilia-Romagna Italy 47014
93 GSK Investigational Site Ravenna Emilia-Romagna Italy 48123
94 GSK Investigational Site Roma Lazio Italy 00161
95 GSK Investigational Site Brescia Lombardia Italy 25123
96 GSK Investigational Site Milano Lombardia Italy 20141
97 GSK Investigational Site Pavia Lombardia Italy 27100
98 GSK Investigational Site Ancona Marche Italy 60126
99 GSK Investigational Site San Giovanni Rotondo Puglia Italy 71013
100 GSK Investigational Site Siena Toscana Italy 53100
101 GSK Investigational Site Terni Umbria Italy 05100
102 GSK Investigational Site Milano Italy 20122
103 GSK Investigational Site Aichi Japan 467-8602
104 GSK Investigational Site Chiba Japan 277-8567
105 GSK Investigational Site Ehime Japan 790-8524
106 GSK Investigational Site Fukushima Japan 960-1295
107 GSK Investigational Site Gifu Japan 503-8502
108 GSK Investigational Site Gunma Japan 377-0280
109 GSK Investigational Site Hokkaido Japan 060-8648
110 GSK Investigational Site Kyoto Japan 602-8566
111 GSK Investigational Site Kyoto Japan 603-8151
112 GSK Investigational Site Osaka Japan 565-0871
113 GSK Investigational Site Saitama Japan 350-8550
114 GSK Investigational Site Tokushima Japan 770-8503
115 GSK Investigational Site Tokyo Japan 108-8639
116 GSK Investigational Site Tokyo Japan 135-8550
117 GSK Investigational Site Tokyo Japan 150-8935
118 GSK Investigational Site Goyang-si Gyeonggi-Do Korea, Republic of 410-769
119 GSK Investigational Site Seongnam-si Gyeonggi-do Korea, Republic of 13620
120 GSK Investigational Site Hwasun Korea, Republic of 58128
121 GSK Investigational Site Incheon Korea, Republic of 405-760
122 GSK Investigational Site Seoul Korea, Republic of 03080
123 GSK Investigational Site Seoul Korea, Republic of 05505
124 GSK Investigational Site Seoul Korea, Republic of 06591
125 GSK Investigational Site Amersfoort Netherlands 3813 TZ
126 GSK Investigational Site Rotterdam Netherlands 3015 GD
127 GSK Investigational Site Gdansk Poland 80-952
128 GSK Investigational Site Krakow Poland 30510
129 GSK Investigational Site Krakow Poland 31-501
130 GSK Investigational Site Torun Poland 87-100
131 GSK Investigational Site Warszawa Poland 02106
132 GSK Investigational Site Ekaterinburg Russian Federation 620102
133 GSK Investigational Site Kaluga Russian Federation 248007
134 GSK Investigational Site Kemerovo Russian Federation 650066
135 GSK Investigational Site Kirov Russian Federation 610027
136 GSK Investigational Site Krasnoyarsk Russian Federation 660022
137 GSK Investigational Site Nizhny Novgorod Russian Federation 603137
138 GSK Investigational Site Novosibirsk Russian Federation 630087
139 GSK Investigational Site Saint Petersburg Russian Federation 197341
140 GSK Investigational Site Samara Russian Federation 443021
141 GSK Investigational Site Sochi Russian Federation 354057
142 GSK Investigational Site St'Petersburg Russian Federation 191024
143 GSK Investigational Site Syktyvkar Russian Federation 167904
144 GSK Investigational Site Tula Russian Federation 300053
145 GSK Investigational Site Yaroslavl Russian Federation 150062
146 GSK Investigational Site Badalona Spain 08916
147 GSK Investigational Site Barcelona Spain 08036
148 GSK Investigational Site Hospitalet de Llobregat (Barcelona) Spain 08908
149 GSK Investigational Site Malaga Spain 29004
150 GSK Investigational Site Pamplona Spain 31008
151 GSK Investigational Site Pozuelo De Alarcón/Madrid Spain 28223
152 GSK Investigational Site Salamanca Spain 37007
153 GSK Investigational Site Santiago de Compostela Spain 15706
154 GSK Investigational Site Valencia Spain 46017
155 GSK Investigational Site Airdrie Lanarkshire United Kingdom ML6 0JS
156 GSK Investigational Site Stoke-on-Trent Staffordshire United Kingdom ST4 6QG
157 GSK Investigational Site Dundee United Kingdom DD1 9SY
158 GSK Investigational Site Edinburgh United Kingdom EH4 2XU
159 GSK Investigational Site London United Kingdom EC1 7ED
160 GSK Investigational Site London United Kingdom W12 0NN
161 GSK Investigational Site Manchester United Kingdom M20 4BX
162 GSK Investigational Site Nottingham United Kingdom NG5 1PB
163 GSK Investigational Site Oxford United Kingdom OX3 7LJ
164 GSK Investigational Site Plymouth United Kingdom PL6 8D8

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT04162210
Other Study ID Numbers:
  • 207495
  • 2018-004252-38
First Posted:
Nov 14, 2019
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022