Actively Recruiting
A Multicenter, Randomized, Double-blind Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Bicara Therapeutics · Updated on 2026-06-02
650
Participants Needed
173
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This study focuses on targeting two cancer drivers, EGFR and TGF-β, which promote tumor growth and spread. The research is conducted in two phases to identify the best dose and compare treatment outcomes. In Phase 2, participants are randomly assigned to one of three groups: high-dose ficerafusp alfa with pembrolizumab, lower-dose ficerafusp alfa with pembrolizumab, or placebo with pembrolizumab. Phase 3 compares the chosen optimal dose of ficerafusp alfa plus pembrolizumab against placebo plus pembrolizumab with a 2:1 randomization ratio. Treatments are given weekly or every three weeks according to the study arm. Participants will undergo regular evaluations including scans to measure tumor response, safety monitoring for side effects, and quality of life assessments. The study measures outcomes such as tumor response rate, overall survival, progression-free survival, and treatment safety over periods ranging from one to three years. Researchers will also monitor treatment-related adverse events and the impact on symptoms and pain throughout the study.
CONDITIONS
Brief Title
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Histologically or cytologically confirmed recurrent or metastatic Head and Neck Squamous Cell Carcinoma
- Eligible primary tumor locations: oral cavity, hypopharynx, larynx, or oropharynx with documented HPV-negative disease for oropharyngeal squamous cell carcinoma
- No prior systemic therapy for recurrent or metastatic disease; completed systemic therapy more than 6 months prior if given as part of multimodal treatment for locoregionally advanced disease
- Archival tumor tissue available or willing to undergo pretreatment biopsy if needed
- PD-L1 Combined Positive Score (CPS) of 1 or higher
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined in the study protocol
You will not qualify if you...
- Disease suitable for local treatment with curative intent
- Prior treatment with anti-TGF-beta therapy
- Prior therapy with anti-EGFR antibodies except for radiosensitizing agents or multimodal locoregional treatment
- History of Grade 2 or higher intolerance or hypersensitivity to anti-EGFR therapy or murine proteins
- Prior immune checkpoint inhibitor therapy within 6 months before study treatment
- Progressive disease less than 6 months after curative systemic therapy for locoregionally advanced disease
- Life expectancy less than 3 months
- Known active central nervous system metastases or history of spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Active major bleeding or recent major bleeding episode within 4 weeks prior to enrollment
- Participation in another clinical study or investigational drug treatment within 5 half-lives or 4 weeks prior to study
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Chronic active hepatitis B without suppressive antiviral therapy prior to study treatment
- Known hepatitis C infection without completed curative treatment or detectable viral load at screening
- Known history of HIV infection
- Receipt of any organ transplantation requiring immunosuppression except some exceptions
- Additional malignancies within 2 years prior to randomization except certain curatively treated skin and cervical or breast cancers, and low-risk prostate cancer
- Requirement for systemic corticosteroids or immunosuppressive treatment within 7 days prior to first dose except certain topical or local steroids
- Use of live or live attenuated vaccines within 4 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years depending on study phase and response
Participants receive ficerafusp alfa or placebo once weekly and pembrolizumab every three weeks as first-line treatment for PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma.
Weekly visits for ficerafusp alfa or placebo dosing and every 3 weeks for pembrolizumab dosing
Duration - Up to 90 days for serious adverse events and approximately 3 years for survival follow-up
Participants are monitored for treatment-emergent adverse events and overall survival outcomes after treatment ends.
Periodic visits as scheduled for safety and survival assessments
Trial Site Locations
Total: 173 locations
1
Site # 0137
Birmingham, Alabama, United States, 35233
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2
Site #0147
Phoenix, Arizona, United States, 85054
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3
Site #0107
La Jolla, California, United States, 92093
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4
Site #0106
Los Angeles, California, United States, 90095
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5
Site#0144
Sacramento, California, United States, 95817
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6
Site #0130
San Francisco, California, United States, 94143
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7
Site #0150
Stanford, California, United States, 94305
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8
Site #0122
Aurora, Colorado, United States, 80012
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9
Site #0124
Aurora, Colorado, United States, 80045
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10
Site#0121
Aurora, Colorado, United States, 80045
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11
Site#0127
Newark, Delaware, United States, 19713
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12
Site #0148
Jacksonville, Florida, United States, 32224
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13
Site #0136
Palm Bay, Florida, United States, 32901
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14
Site #0105
Tampa, Florida, United States, 33612
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15
Site #0133
Chicago, Illinois, United States, 60064
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16
Site#0140
Iowa City, Iowa, United States, 52242
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17
Site #0149
Westwood, Kansas, United States, 66205
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18
Site#0109
Lexington, Kentucky, United States, 40536
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19
Site#0111
Louisville, Kentucky, United States, 40202
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20
Site#0115
Louisville, Kentucky, United States, 40202
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21
Site #0112
Baltimore, Maryland, United States, 21201
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22
Site #0131
Boston, Massachusetts, United States, 02114
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23
Site#0101
Boston, Massachusetts, United States, 02136
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24
Site #0156
Maplewood, Minnesota, United States, 55109
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25
Site #0146
Rochester, Minnesota, United States, 55905
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26
Site #0114
St Louis, Missouri, United States, 63110
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27
Site #0119
Hackensack, New Jersey, United States, 07601
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28
Site #0145
Newark, New Jersey, United States, 07103
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29
Site #0155
New York, New York, United States, 10003
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30
Site#0142
New York, New York, United States, 10021
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31
Site#0118
Durham, North Carolina, United States, 27703
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32
Site#0154
Canton, Ohio, United States, 44708
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33
Site#0117
Cincinnati, Ohio, United States, 45221
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34
Site #0151
Cleveland, Ohio, United States, 44106
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35
Site #0108
Cleveland, Ohio, United States, 44195
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36
Site #0113
Portland, Oregon, United States, 97213
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37
Site #0103
Pittsburgh, Pennsylvania, United States, 15206
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38
Site #0123
Pittsburgh, Pennsylvania, United States, 15240
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39
Site #0132
Providence, Rhode Island, United States, 02903
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40
Site#0104
Charleston, South Carolina, United States, 29425
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41
Site#0126
Nashville, Tennessee, United States, 37203
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42
Site #0116
Nashville, Tennessee, United States, 37232
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43
Site#0102
Houston, Texas, United States, 77005
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44
Site #0152
Waco, Texas, United States, 676712
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45
Site#0134
Charlottesville, Virginia, United States, 22904
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46
Site #0129
Richmond, Virginia, United States, 23219
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47
Site #0138
Richmond, Virginia, United States, 23249
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48
Site # 0160
Edmonds, Washington, United States, 98026
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49
Site # 0159
Seattle, Washington, United States, 98104
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50
Site #0125
Seattle, Washington, United States, 98109
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51
Site#0120
Vancouver, Washington, United States, 98684
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52
Site #0141
Madison, Wisconsin, United States, 53705
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53
Site #0157
Madison, Wisconsin, United States, 53792
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54
Site # 2301
Buenos Aires, Argentina, C1190
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55
Site # 2306
Buenos Aires, Argentina, C1425
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56
Site # 2305
Rosario, Argentina, CP2000
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57
Site # 2302
Santa Fe, Argentina, S2002KDT
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58
Site#0302
Camperdown, New South Wales, Australia, 2050
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59
Site #0306
Kingswood, New South Wales, Australia, 2747
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60
Site#0304
Waratah, New South Wales, Australia, 2298
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61
Site #0305
Southport, Queensland, Australia, 4215
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62
Site#0307
Tugun, Queensland, Australia, 4224
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63
Site #0303
Heidelberg, Victoria, Australia, 3084
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64
Site#0301
North Melbourne, Victoria, Australia, 3051
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65
Site#0308
Murdoch, Western Australia, Australia, 6150
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66
Site #1602
Salzburg, Austria, 5020
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67
Site #1601
Vienna, Austria, 1090
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68
Site #1007
Bruges, Belgium, 8000
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69
Site #1005
Mons, Belgium, 7000
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70
Site #1002
Namur, Belgium, 5000
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71
Site #1003
Namur, Belgium, 5530
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72
Site #1001
Sint-Niklaas, Belgium, 9100
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73
Site #1006
Wilrijk, Belgium, 2610
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74
Site # 0215
Santa Cruz do Sul, Brazil, 96835-100
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75
Site # 2406
São José do Rio Preto, Brazil, 15090-000
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76
Site #0202
Vancouver, British Columbia, Canada, V5Z 4E6
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77
Site #0203
Montreal, Quebec, Canada, H2X 0C1
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78
Site # 0204
Toronto, Canada, M4N 3M5
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79
Site # 2101
Hradec Králové, Czechia, 500 03
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80
Site #2102
Prague, Czechia, 15006
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81
Site #0809
Amiens, France, 80480
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82
Site # 0812
Bordeaux, France, 33075
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83
Site # 0804
Lille, France, 59000
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84
Site #0810
Lyon, France, 69004
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85
Site # 0813
Paris, France, 75005
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86
Site #0805
Rennes, France, 35042
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87
Site #0807
Saint-Grégoire, France, 35760
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88
Site #0808
Strasbourg, France, 67200
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89
Site # 0811
Toulouse, France, 31059
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90
Site #0806
Vandœuvre-lès-Nancy, France, 54519
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91
Site #0801
Villejuif, France, 94805
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92
Site #0710
Aachen, Germany, 52074
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93
Site # 0701
Berlin, Germany, 12200
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94
Site # 0714
Berlin, Germany, 12351
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95
Site # 0709
Braunschweig, Germany, 38114
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96
Site # 0705
Chemnitz, Germany, 09116
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97
Site #0707
Dresden, Germany, 01067
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98
Site #0706
Düsseldorf, Germany, 40225
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99
Site # 0718
Hanover, Germany, 30625
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100
Site #0717
Karlsruhe, Germany, 76137
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101
Site # 0715
München, Germany, 81675
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102
Site # 0703
Stuttgart, Germany, 70174
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103
Site # 0702
Ulm, Germany, 89075
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104
Site # 1701
Athens, Greece, 12461
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105
Site # 1702
Larissa, Greece, 41110
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106
Site # 0603
Cork, Ireland, T12 DC4A
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107
Site #0602
Dublin, Ireland, D08 NHY1
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108
Site #0601
Dublin, Ireland, D09 V2N0
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109
Site #0904
Bologna, Italy, 40138
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110
Site #0911
Florence, Italy, 50134
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111
Site #0907
Milan, Italy, 20132
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112
Site #0901
Milan, Italy, 20133
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113
Site #0905
Milan, Italy, 20142
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114
Site # 0912
Milan, Italy, 20162
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115
Site #0915
Naples, Italy, 80131
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116
Site #0908
Palermo, Italy, 90127
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117
Site # 0903
Pavia, Italy, 27100
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118
Site # 0909
Pisa, Italy, 56126
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119
Site #0917
Rome, Italy, 00161
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120
Site #0918
Rome, Italy, 00168
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121
Site #0906
Rome, Italy, 00186
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122
Site # 0919
Rozzano, Italy, 20089
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123
Site # 0902
Siena, Italy, 53100
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124
Site # 2802
George Town, Malaysia, 11200
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125
Site # 2803
Kuala Lumpur, Malaysia, 50586
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126
Site # 2801
Kuching, Malaysia, 93200
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127
Site #0401
Christchurch, New Zealand, 8011
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128
Site#0402
Rotorua, New Zealand, 3010
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129
Site #1401
Gdansk, Poland, 80-214
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130
Site # 1405
Gliwice, Poland, 44-102
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131
Site #1403
Katowice, Poland, 40-519
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132
Site #1407
Konin, Poland, 62-500
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133
Site #1404
Krakow, Poland, 31-826
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134
Site #1402
Siedlce, Poland, 08-110
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135
Site #1406
Warsaw, Poland, 02-781
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136
Site #1506
Braga, Portugal, 4710-243
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137
Site #1503
Coimbra, Portugal
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138
Site #1508
Lisbon, Portugal, 1099-023
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139
Site #1501
Portimão, Portugal, 8500-338
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140
Site #1505
Porto, Portugal, 4200-072
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141
Site #1507
Porto, Portugal, 4200-319
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142
Site #1502
Senhora da Hora, Portugal, 4464-509
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143
Site # 1504
Vila Nova de Gaia, Portugal, 4434-502
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144
Site # 2901
Singapore, Singapore, 168583
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145
Site # 2705
Hwasun, South Korea, 58128
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146
Site # 2706
Seongnam, South Korea, 13620
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147
Site # 2701
Seoul, South Korea, 3080
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148
Site #1301
Barcelona, Spain, 08035
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149
Site #1305
Barcelona, Spain, 08036
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150
Site #1304
Barcelona, Spain, 08041
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151
Site # 1302
Barcelona, Spain, 08908
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152
Site #1310
Madrid, Spain, 28027
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153
Site #1303
Madrid, Spain, 28041
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154
Site #1306
Pamplona, Spain, 31008
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155
Site #1309
Santander, Spain, 39008
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156
Site #1307
Valencia, Spain, 46010
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157
Site #1308
Valencia, Spain, 46014
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158
Site # 1802
Geneva, Switzerland, 1205
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159
Site # 2604
Taipei, Taiwan, 10002
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160
Site #0504
Aberdeen, United Kingdom, AB25 2ZN
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161
Site #0512
Birmingham, United Kingdom, B15 2TH
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162
Site #0513
Cambridge, United Kingdom, CB2 0QQ
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163
Site # 0510
Glasgow, United Kingdom, G12 0YN
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164
Site #0511
Leeds, United Kingdom, LS9 7TF
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165
Site #0507
Liverpool, United Kingdom, L7 8YA
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166
Site #0505
London, United Kingdom, SW3 6JJ
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167
Site #0502
London, United Kingdom, WC1E 6AG
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168
Site #0508
Manchester, United Kingdom, M20 4BX
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169
Site #0506
Middlesex, United Kingdom, HA6 2RN
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170
Site #0503
Nottingham, United Kingdom, NG5 1PB
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171
Site #0515
Oxford, United Kingdom, OX3 7LE
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172
Site # 0514
Portsmouth, United Kingdom, PO6 3LY
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173
Site # 0501
Sutton, United Kingdom, SM2 5PT
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Research Team
M
Medical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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