FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony w badaniu histopatologicznym rak płaskonabłonkowy głowy i szyi, który się rozprzestrzeniał lub powrócił
- •Brak wcześniejszego leczenia chemioterapią w przypadku choroby zaawansowanej
- •Posiadanie próbki guza do analizy laboratoryjnej lub zgoda na pobranie próbki
- •Określony marker w guzie (PD-L1 CPS ≥1)
- •Zmierzoną chorobę widoczną w badaniach obrazowych
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-1)
- •Prawidłowe funkcjonowanie nerek, wątroby i innych narządów
✗ Disqualifies
- •Nowotwór możliwy do wyleczenia operacją lub radioterapią
- •Wcześniejsze leczenie lekami anty-TGF-beta
- •Wcześniejsze leczenie przeciwciałami anty-EGFR
- •Ciężka alergiczna reakcja na poprzednie leczenie anty-EGFR
- •Leczenie inhibitorami immunologicznymi w ciągu ostatnich 6 miesięcy
- •Przerzuty do mózgu, zapalenie opon mózgowych lub uciśnięcie rdzenia kręgowego
- •Aktywne poważne krwawienie lub krwawienie w ostatnich 4 tygodniach
- •Spodziewana długość życia poniżej 3 miesięcy
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 17, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (203)
Site # 0137
Birmingham, United States
Site #0147
Phoenix, United States
Site #0107
La Jolla, United States
Site #0106
Los Angeles, United States
Site#0144
Sacramento, United States
Site #0130
San Francisco, United States
Site #0150
Stanford, United States
Site #0122
Aurora, United States
Site #0124
Aurora, United States
Site#0121
Aurora, United States
Site #0148
Jacksonville, United States
Site #0136
Palm Bay, United States
Site #0105
Tampa, United States
Site#0140
Iowa City, United States
Site #0149
Westwood, United States
Site#0111
Louisville, United States
Site#0115
Louisville, United States
Site #0112
Baltimore, United States
Site #0131
Boston, United States
Site#0101
Boston, United States
Site #0156
Maplewood, United States
Site #0146
Rochester, United States
Site #0114
St Louis, United States
Site #0145
Newark, United States
Site #0155
New York, United States
Site#0142
New York, United States
Site#0118
Durham, United States
Site#0154
Canton, United States
Site#0117
Cincinnati, United States
Site #0151
Cleveland, United States
Site #0108
Cleveland, United States
Site #0113
Portland, United States
Site #0103
Pittsburgh, United States
Site #0123
Pittsburgh, United States
Site #0132
Providence, United States
Site#0104
Charleston, United States
Site#0126
Nashville, United States
Site #0116
Nashville, United States
Site#0102
Houston, United States
Site #0152
Waco, United States
Site#0134
Charlottesville, United States
Site #0129
Richmond, United States
Site #0138
Richmond, United States
Site # 0160
Edmonds, United States
Site # 0159
Seattle, United States
Site #0125
Seattle, United States
Site#0120
Vancouver, United States
Site #0141
Madison, United States
Site #0157
Madison, United States
Site # 0153
Milwaukee, United States
Site # 2301
Buenos Aires, Argentina
Site # 2306
Buenos Aires, Argentina
Site # 2303
Pilar, Argentina
Site # 2305
Rosario, Argentina
Site # 2302
Santa Fe, Argentina
Site#0302
Camperdown, Australia
Site #0306
Kingswood, Australia
Site#0304
Waratah, Australia
Site #0305
Southport, Australia
Site#0307
Tugun, Australia
Site #0303
Heidelberg, Australia
Site#0301
North Melbourne, Australia
Site#0308
Murdoch, 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 # 2420
Santa Cecília, Brazil
Site # 2413
Barretos, Brazil
Site # 2404
Curitiba, Brazil
Site # 2402
Ijuí, Brazil
Site # 2411
Jaú, Brazil
Site # 2422
Natal, Brazil
Site # 2419
Passo Fundo, Brazil
Site # 2412
Rio de Janeiro, Brazil
Site # 2415
Santa Cruz do Sul, Brazil
Site # 2401
Santa Lúcia, Brazil
Site # 2406
São José do Rio Preto, Brazil
Site # 2405
São Paulo, Brazil
Site # 2416
São Paulo, Brazil
Site #0202
Vancouver, Canada
Site #0203
Montreal, Canada
Site # 0204
Toronto, Canada
Site # 2101
Hradec Králové, Czechia
Site #2102
Prague, Czechia
Site #0809
Amiens, France
Site # 0812
Bordeaux, France
Site # 0804
Lille, France
Site #0810
Lyon, France
Site # 0813
Paris, France
Site #0805
Rennes, France
Site #0807
Saint-Grégoire, France
Site #0808
Strasbourg, France
Site # 0811
Toulouse, France
Site #0806
Vandœuvre-lès-Nancy, France
Site #0801
Villejuif, France
Site #0710
Aachen, Germany
Site # 0701
Berlin, Germany
Site # 0714
Berlin, Germany
Site # 0709
Braunschweig, Germany
Site # 0705
Chemnitz, Germany
Site #0707
Dresden, Germany
Site # 0711
Dresden, Germany
Site #0706
Düsseldorf, Germany
Site # 0716
Essen, Germany
Site # 0708
Göttingen, Germany
Site # 0718
Hanover, Germany
Site #0717
Karlsruhe, Germany
Site # 0715
München, Germany
Site # 0703
Stuttgart, Germany
Site # 0702
Ulm, Germany
Site # 1701
Athens, Greece
Site # 1702
Larissa, Greece
Site # 3002
Sūrat, India
Site # 0603
Cork, Ireland
Site #0602
Dublin, Ireland
Site #0601
Dublin, Ireland
Site # 1903
Jerusalem, Israel
Site # 1902
Tel Aviv, Israel
Site #0904
Bologna, Italy
Site #0911
Florence, Italy
Site #0907
Milan, Italy
Site #0901
Milan, Italy
Site #0905
Milan, Italy
Site # 0912
Milan, Italy
Site # 0916
Naples, Italy
Site #0915
Naples, Italy
Site # 0910
Padova, Italy
Site #0908
Palermo, Italy
Site # 0903
Pavia, Italy
Site # 0909
Pisa, Italy
Site #0917
Rome, Italy
Site #0918
Rome, Italy
Site #0906
Rome, Italy
Site # 0919
Rozzano, Italy
Site # 0902
Siena, Italy
Site # 2802
George Town, Malaysia
Site # 2803
Kuala Lumpur, Malaysia
Site # 2805
Kuala Lumpur, Malaysia
Site # 2801
Kuching, Malaysia
Site # 2804
Pulau Pinang, Malaysia
Site #0401
Christchurch, New Zealand
Site#0402
Rotorua, New Zealand
Site #1401
Gdansk, Poland
Site # 1405
Gliwice, 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 # 1504
Vila Nova de Gaia, Portugal
Site # 2902
Novena, Singapore
Site # 2901
Singapore, Singapore
Site # 2707
Busan, South Korea
Site # 2704
Goyang-si, South Korea
Site # 2705
Hwasun, South Korea
Site # 2706
Seongnam, South Korea
Site # 2701
Seoul, South Korea
Site # 2702
Seoul, South Korea
Site # 1311
Badalona, Spain
Site #1301
Barcelona, Spain
Site #1305
Barcelona, Spain
Site #1304
Barcelona, Spain
Site # 1302
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 # 1803
Fribourg, Switzerland
Site # 1802
Geneva, Switzerland
Site # 1801
Lausanne, Switzerland
Site # 2602
Changhua, Taiwan
Site # 2601
Kaohsiung City, Taiwan
Site # 2603
Taichung, Taiwan
Site # 2604
Taipei, Taiwan
Site # 1201
Ankara, Turkey (Türkiye)
Site #0504
Aberdeen, United Kingdom
Site #0512
Birmingham, United Kingdom
Site #0513
Cambridge, United Kingdom
Site # 0510
Glasgow, 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 # 0514
Portsmouth, United Kingdom
Site # 0501
Sutton, United Kingdom
Trial contact
Medical Affairs
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.
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