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FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Sponsor: Bicara Therapeutics
Summary
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Official title: A Multicenter, Randomized, Double-blind, Phase 2/3 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2025-01-28
Completion Date
2029-07
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Ficerafusp alfa
Investigational
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Placebo
Placebo Control
Locations (129)
Site # 0137
Birmingham, Alabama, United States
Site #0147
Phoenix, Arizona, United States
Site #0107
La Jolla, California, United States
Site #0106
Los Angeles, California, United States
Site#0144
Sacramento, California, United States
Site #0130
San Francisco, California, United States
Site #0150
Stanford, California, United States
Site #0122
Aurora, Colorado, United States
Site #0124
Aurora, Colorado, United States
Site#0121
Aurora, Colorado, United States
Site#0127
Newark, Delaware, United States
Site #0148
Jacksonville, Florida, United States
Site #0136
Palm Bay, Florida, United States
Site #0105
Tampa, Florida, United States
Site #0133
Chicago, Illinois, United States
Site#0140
Iowa City, Iowa, United States
Site #0149
Westwood, Kansas, United States
Site#0109
Lexington, Kentucky, United States
Site#0111
Louisville, Kentucky, United States
Site#0115
Louisville, Kentucky, United States
Site #0112
Baltimore, Maryland, United States
Site #0131
Boston, Massachusetts, United States
Site#0101
Boston, Massachusetts, United States
Site #0156
Maplewood, Minnesota, United States
Site #0146
Rochester, Minnesota, United States
Site #0114
St Louis, Missouri, United States
Site #0119
Hackensack, New Jersey, United States
Site #0145
Newark, New Jersey, United States
Site #0155
New York, New York, United States
Site#0142
New York, New York, United States
Site#0118
Durham, North Carolina, United States
Site#0154
Canton, Ohio, United States
Site#0117
Cincinnati, Ohio, United States
Site #0151
Cleveland, Ohio, United States
Site #0108
Cleveland, Ohio, United States
Site #0113
Portland, Oregon, United States
Site #0103
Pittsburgh, Pennsylvania, United States
Site #0123
Pittsburgh, Pennsylvania, United States
Site #0132
Providence, Rhode Island, United States
Site#0104
Charleston, South Carolina, United States
Site#0126
Nashville, Tennessee, United States
Site #0116
Nashville, Tennessee, United States
Site#0102
Houston, Texas, United States
Site #0152
Waco, Texas, United States
Site#0134
Charlottesville, Virginia, United States
Site #0129
Richmond, Virginia, United States
Site #0138
Richmond, Virginia, United States
Site #0125
Seattle, Washington, United States
Site#0120
Vancouver, Washington, United States
Site #0141
Madison, Wisconsin, United States
Site #0157
Madison, Wisconsin, United States
Site#0302
Camperdown, New South Wales, Australia
Site #0306
Kingswood, New South Wales, Australia
Site#0304
Waratah, New South Wales, Australia
Site #0305
Southport, Queensland, Australia
Site#0307
Tugun, Queensland, Australia
Site #0303
Heidelberg, Victoria, Australia
Site#0301
North Melbourne, Victoria, Australia
Site#0308
Murdoch, Western Australia, Australia
Site #1602
Salzburg, Austria
Site #1601
Vienna, Austria
Site #1007
Bruges, Belgium
Site #1005
Mons, Belgium
Site #1002
Namur, Belgium
Site #1003
Namur, Belgium
Site #1001
Sint-Niklaas, Belgium
Site #1006
Wilrijk, Belgium
Site #0202
Vancouver, British Columbia, Canada
Site #0203
Montreal, Quebec, Canada
Site #2102
Prague, Czechia
Site #0809
Amiens, France
Site #0810
Lyon, France
Site #0805
Rennes, France
Site #0807
Saint-Grégoire, France
Site #0808
Strasbourg, France
Site #0806
Vandœuvre-lès-Nancy, France
Site #0801
Villejuif, France
Site #0710
Aachen, Germany
Site #0707
Dresden, Germany
Site #0706
Düsseldorf, Germany
Site #0717
Karlsruhe, Germany
Site #0602
Dublin, Ireland
Site #0601
Dublin, Ireland
Site #0904
Bologna, Italy
Site #0911
Florence, Italy
Site #0907
Milan, Italy
Site #0901
Milan, Italy
Site #0905
Milan, Italy
Site #0915
Naples, Italy
Site #0908
Palermo, Italy
Site #0917
Rome, Italy
Site #0918
Rome, Italy
Site #0906
Rome, Italy
Site #0401
Christchurch, New Zealand
Site#0402
Rotorua, New Zealand
Site #1401
Gdansk, Poland
Site #1403
Katowice, Poland
Site #1407
Konin, Poland
Site #1404
Krakow, Poland
Site #1402
Siedlce, Poland
Site #1406
Warsaw, Poland
Site #1506
Braga, Portugal
Site #1503
Coimbra, Portugal
Site #1508
Lisbon, Portugal
Site #1501
Portimão, Portugal
Site #1505
Porto, Portugal
Site #1507
Porto, Portugal
Site #1502
Senhora da Hora, Portugal
Site #1301
Barcelona, Spain
Site #1305
Barcelona, Spain
Site #1304
Barcelona, Spain
Site #1310
Madrid, Spain
Site #1303
Madrid, Spain
Site #1306
Pamplona, Spain
Site #1309
Santander, Spain
Site #1307
Valencia, Spain
Site #1308
Valencia, Spain
Site #0504
Aberdeen, United Kingdom
Site #0512
Birmingham, United Kingdom
Site #0513
Cambridge, United Kingdom
Site #0511
Leeds, United Kingdom
Site #0507
Liverpool, United Kingdom
Site #0505
London, United Kingdom
Site #0502
London, United Kingdom
Site #0508
Manchester, United Kingdom
Site #0506
Middlesex, United Kingdom
Site #0503
Nottingham, United Kingdom
Site #0515
Oxford, United Kingdom
Site # 0501
Sutton, United Kingdom