AzTrials
AzTrials

Metastatic Head and Neck Squamous Cell CarcinomaPhase 2/3FORTIFI-HN01NCT06788990

FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

A Phase 2/3 study testing Ficerafusp alfa and Pembrolizumab (KEYTRUDA®) in people with Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by Bicara Therapeutics at 231 sites in 28 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ficerafusp alfa and Pembrolizumab (KEYTRUDA®)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
231 sitesin 28 countries
Study dates
28 Jan 2025to Jul 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years on the day the Informed Consent Form is signed.
  • Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.
  • No prior systemic therapy administered in the R or M setting; and completed systemic therapy >6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting.
  • Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.
  • PD-L1 CPS ≥1.
  • Measurable disease based on RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function, as defined in the protocol.

Who cannot join

  • Disease suitable for local therapy administered with curative intent.
  • Prior treatment with anti-TGFβ therapy.
  • Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
  • Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
  • Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
  • Progressive disease <6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.
Show all 19Show fewer
  • Life expectancy less than 3 months.
  • Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
  • Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.
  • Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
  • Active autoimmune disease requiring systemic treatment in the past 2 years.
  • Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
  • Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.
  • Known history of human immunodeficiency virus (HIV).
  • Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
  • Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
  • Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
  • Use of a live or live attenuated vaccine within 4 weeks prior to Screening.
  • Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Trial locations and contacts

231 sites in 28 countries. Contact the study team or a site near you to ask about taking part.

Medical Affairs contact

1-617-468-4219

FORTIFI_inquiries@bicara.com

231 sites in 28 countries

United States55 sites, 55 recruiting

  • University of Michigan (Site # 161)

    Ann Arbor, Michigan, 48109

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Rocky Mountain Cancer Centers, LLP (Site #0122)

    Aurora, Colorado, 80012

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Rocky Mountain Regional VAMC (Site #0124)

    Aurora, Colorado, 80045

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Site#0121)

    Aurora, Colorado, 80045

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Maryland Medical Group (Site #0112)

    Baltimore, Maryland, 21201

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Alabama Hospital (Site # 0137)

    Birmingham, Alabama, 35233

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Massachusetts General Hospital (Site #0131)

    Boston, Massachusetts, 02114

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Dana-Farber Cancer Institute (Site#0101)

    Boston, Massachusetts, 02136

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mercy Hospital (Site#0154)

    Canton, Ohio, 44708

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Medical University of South Carolina (MUSC) (Site#0104)

    Charleston, South Carolina, 29425

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Virginia (Site#0134)

    Charlottesville, Virginia, 22904

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Captain James A Lovell Federal Health Care Center-VA North Chicago (Site # 133)

    Chicago, Illinois, 60064

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Cincinnati Cancer Institute (Site#0117)

    Cincinnati, Ohio, 45221

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University Hospitals Seidman Cancer Center (Site #0151)

    Cleveland, Ohio, 44106

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Cleveland Clinic (Site #0108)

    Cleveland, Ohio, 44195

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Duke University Health System (Site#0118)

    Durham, North Carolina, 27703

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Swedish Cancer Institute - North Campus Edmonds (Site # 0160)

    Edmonds, Washington, 98026

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hackensack Meridian Health (Site # 119)

    Hackensack, New Jersey, 07601

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • MD Anderson Cancer Center (Site#0102)

    Houston, Texas, 77005

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Iowa Hospitals & Clinics (Site#0140)

    Iowa City, Iowa, 52242

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mayo Clinic Florida (Site #0148)

    Jacksonville, Florida, 32224

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • UC San Diego Moores Cancer Center (Site #0107)

    La Jolla, California, 92093

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Kentucky, Markey Cancer Center (Site # 109)

    Lexington, Kentucky, 40536

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology (Site #0106)

    Los Angeles, California, 90095

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Norton Cancer Institute (Site#0111)

    Louisville, Kentucky, 40202

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • The University of Louisville, James Graham Brown Cancer Center (Site#0115)

    Louisville, Kentucky, 40202

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • William S. Middleton Memorial Veteran's Hospital (Site #0141)

    Madison, Wisconsin, 53705

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Wisconsin Hospital and Clinics (Site #0157)

    Madison, Wisconsin, 53792

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Site #0156

    Maplewood, Minnesota, 55109

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Advocate Aurora Research Institute (Site # 0153)

    Milwaukee, Wisconsin, 53233

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • SCRI-Oncology Partners (Site#0126)

    Nashville, Tennessee, 37203

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Vanderbilt-Ingram Cancer Center (Site #0116)

    Nashville, Tennessee, 37232

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mount Sinai (Site #0155)

    New York, New York, 10003

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Memorial Sloan Kettering Cancer Center (Site#0142)

    New York, New York, 10021

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • ChristianaCare Helen F. Graham Cancer Center and Research Institute (Site # 127)

    Newark, Delaware, 19713

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Rutgers- Cancer Institute (Site #0145)

    Newark, New Jersey, 07103

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Cancer Care Centers of Brevard (Site #0136)

    Palm Bay, Florida, 32901

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mayo Clinic Hospital (Site #0147)

    Phoenix, Arizona, 85054

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • UPMC Hillman Cancer Center (Site #0103)

    Pittsburgh, Pennsylvania, 15206

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • VA Pittsburgh Healthcare System (Site #0123)

    Pittsburgh, Pennsylvania, 15240

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Providence Portland Medical Center (Site #0113)

    Portland, Oregon, 97213

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Lifespan Cancer Institute (Site #0132)

    Providence, Rhode Island, 02903

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Virginia Commonwealth University (VCU) Massey Cancer Center (Site #0129)

    Richmond, Virginia, 23219

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Richmond Department of Veterans Affairs (Site #0138)

    Richmond, Virginia, 23249

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mayo Clinic Cancer Center - Rochester (Site #0146)

    Rochester, Minnesota, 55905

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • UC Davis (Site#0144)

    Sacramento, California, 95817

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of California San Francisco (Site #0130)

    San Francisco, California, 94143

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Swedish Cancer Institute (Site # 0159)

    Seattle, Washington, 98104

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Washington - Seattle Cancer Care Alliance (Site #0125)

    Seattle, Washington, 98109

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Washington University School of Medicine (Site #0114)

    St Louis, Missouri, 63110

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Stanford Cancer Institute (Site #0150)

    Stanford, California, 94305

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Moffit Cancer Center (Site #0105)

    Tampa, Florida, 33612

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Northwest Cancer Specialists, PC (Site#0120)

    Vancouver, Washington, 98684

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • SCRI- Texas Oncology- Central South (Site #0152)

    Waco, Texas, 676712

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University of Kansas Medical Center Research Institute, Inc. (Site #0149)

    Westwood, Kansas, 66205

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in United States

Brazil20 sites, 20 recruiting

  • Hospital de Amor de Barretos - Fundação Pio XII (Site # 2413)

    Barretos, 14784-400

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centro de Tratamento Oncologico (Site # 2421)

    Belém, 66063495

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • CIONC-Centro Integrado de Oncologia de Curitiba (Site # 2404)

    Curitiba, 80810-050

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará (Site # 2414)

    Fortaleza, 60430235

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Oncosite - Centro de Pesquisa Clinica e Oncologia (Site # 2402)

    Ijuí, 98700-000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fundação Doutor Amaral Carvalho (Site # 2411)

    Jaú, 17210-120

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Liga Norte-Rio-Grandense Contra o Câncer (Site # 2422)

    Natal, 59062-000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital de Clínicas de Passo Fundo (Site # 2419)

    Passo Fundo, 99010-260

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Nossa Senhora da Conceicao (Site # 2403)

    Porto Alegre, 91350-200

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Grupo Oncoclínicas (Site # 2412)

    Rio de Janeiro, 22250-905

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • AFECC Hospital Santa Rita de Cassia (Site # 2420)

    Santa Cecília, Vitoria ES, 29043-260

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Ana Nery (Site # 2415)

    Santa Cruz do Sul, 96835-100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Oncoclinicas do Brasil Serviços Médicos S.A - Oncocentro BH (Site # 2401)

    Santa Lúcia, 30360680

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centro de Oncologia do ABC - Unidade Santo Andre (Site # 2410)

    São Caetano do Sul, 09541-270

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centro Integrado de Pesquisa do Hospital de Base de São José do Rio Preto/FUNFAR (Site # 2406)

    São José do Rio Preto, 15090-000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Instituto do Cancer do Estado de Sao Paulo (ICESP) (Site # 2417)

    São Paulo, 01246-000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • A. C. Camargo Cancer Center (Site # 2409)

    São Paulo, 01509-900

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • IBCC Núcleo de Pesquisa e Ensino (Site # 2405)

    São Paulo, 04014-002

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Oncoclínicas - SP (Site # 2416)

    São Paulo, 04543

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Santa Marcelina (Site # 2418)

    São Paulo, 08270-120

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Brazil

Italy18 sites, 18 recruiting

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi (Site #0904)

    Bologna, 40138

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • ARNAS G. Brotzu (Site # 913)

    Cagliari, 09121

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi (Site #0911)

    Florence, 50134

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Ospedale San Raffaele (Site #0907)

    Milan, 20132

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori (Site #0901)

    Milan, 20133

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • ASST Santi Paolo e Carlo, Ospedale San Paolo Polo Universitario (Site #0905)

    Milan, 20142

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda (Site # 0912)

    Milan, 20162

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale (Site #0915)

    Naples, 80131

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • UOC Oncoematologia AOU - University Luigi Vanvitelli (Site # 0916)

    Naples, 80131

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • IOV - Istituto Oncologico Veneto IRCCS (Site # 0910)

    Padova, 35128

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Policlinico P. Giaccone di Palermo (Site #0908)

    Palermo, 90127

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo (Site # 0903)

    Pavia, 27100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana (Site # 0909)

    Pisa, 56126

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I (Site #0917)

    Rome, 00161

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fondazione Policlinico Universitario - Agostino Gemelli (Site #0918)

    Rome, 00168

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fatebenefratelli Isola Tiberina, Gemelli Isola (Site #0906)

    Rome, 00186

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Humanitas Mirasole S.p.A (Site # 0919)

    Rozzano, 20089

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • A.O.U. Senese Policlinico Santa Maria alle Scotte (Site # 0902)

    Siena, 53100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Italy

Germany15 sites, 15 recruiting

  • Universitaetsklinikum Aachen AOeR (Site #0710)

    Aachen, 52074

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Charite - Campus Benjamin Franklin (Site # 0701)

    Berlin, 12200

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Vivantes Klinikum Neukoelln (Site # 0714)

    Berlin, 12351

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Staedtisches Klinikum Braunschweig gGmbH (Site # 0709)

    Braunschweig, 38114

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Klinikum Chemnitz gGmbH (Site # 0705)

    Chemnitz, 09116

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt (Site #0707)

    Dresden, 01067

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden (Site # 0711)

    Dresden, 01307

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Heinrich-Heine-Universitaet Duesseldorf (Site #0706)

    Düsseldorf, 40225

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Universitaetsklinikum Essen (Site # 0716)

    Essen, 45147

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Universitaetsmedizin Goettingen (Site # 0708)

    Göttingen, 37075

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Medizinische Hochschule Hannover (Site # 0718)

    Hanover, 30625

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Vincentius-Diakonissen-Kliniken gAG/St. Vincentius-Kliniken (Site #0717)

    Karlsruhe, 76137

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Technische Universität München School of Medicine (Site # 0715)

    München, 81675

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Klinikum Stuttgart-Katharinenhospital (Site # 0703)

    Stuttgart, 70174

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Universitaetsklinikum Ulm (Site # 0702)

    Ulm, 89075

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Germany

United Kingdom15 sites, 15 recruiting

  • Aberdeen Royal Infirmary (Site #0504)

    Aberdeen, AB25 2ZN

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University Hospitals Birmingham (Queen Elizabeth Hospital) (Site #0512)

    Birmingham, B15 2TH

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Cambridge University Hospitals (Site #0513)

    Cambridge, CB2 0QQ

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Beatson West of Scotland Cancer Centre (Site # 0510)

    Glasgow, G12 0YN

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • St James University Hospital Leeds (Site #0511)

    Leeds, LS9 7TF

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Clatterbridge Cancer Center NHS Foundation (Site #0507)

    Liverpool, L7 8YA

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Royal Marsden Hospital - Chelsea (Site #0505)

    London, SW3 6JJ

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University College London Hospital (Site #0502)

    London, WC1E 6AG

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • The Christie Hospital (Site #0508)

    Manchester, M20 4BX

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mount Vernon Cancer Centre (Site #0506)

    Middlesex, HA6 2RN

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Newcastle University (Site # 509)

    Newcastle upon Tyne, NE7 7DN

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Nottingham University Hospitals City Campus (Site #0503)

    Nottingham, NG5 1PB

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Churchill Hospital (Site #0515)

    Oxford, OX3 7LE

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Queen Alexandra Hospital (Site # 0514)

    Portsmouth, PO6 3LY

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Royal Marsden Hospital- London (Site # 0501)

    Sutton, SM2 5PT

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in United Kingdom

France11 sites, 11 recruiting

  • CHU Amiens - Hopital Sud (Site #0809)

    Amiens, 80480

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • CHU de Bordeaux (Site # 0812)

    Bordeaux, 33075

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centre Oscar Lambret (Site # 0804)

    Lille, 59000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centre Hospitalier de la Croix Rousse (Site #0810)

    Lyon, 69004

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Institut Curie - site de Paris (Site # 0813)

    Paris, 75005

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • CRLCC Eugene Marquis (Site #0805)

    Rennes, 35042

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Les Hopitaux Prives Rennais - Saint-Gregoire (Site #0807)

    Saint-Grégoire, 35760

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centre Regional Lutte Contre Le Cancer - PAUL STRAUSS (Site #0808)

    Strasbourg, 67200

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • IUCT-Oncopole (Site # 0811)

    Toulouse, 31059

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • ICL - Alexis Vautrin (Site #0806)

    Vandœuvre-lès-Nancy, 54519

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Institut Gustave Roussy (Site #0801)

    Villejuif, 94805

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in France

Spain11 sites, 11 recruiting

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol (Site # 1311)

    Badalona, 8916

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Universitari Vall d'Hebron (Site #1301)

    Barcelona, 08035

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Clinic de Barcelona (Site #1305)

    Barcelona, 08036

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital de la Santa Creu I Sant Pau Site #1304

    Barcelona, 08041

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Institut Catala d'Oncologia (Site # 1302)

    Barcelona, 08908

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Clinica Universidad de Navarra- Madrid (Site #1310)

    Madrid, 28027

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Universitario 12 De Octubre (Site #1303)

    Madrid, 28041

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Clinica Universidad de Navarra (Site #1306)

    Pamplona, 31008

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Universitario Marques de Valdecilla (HUMV) (Site #1309)

    Santander, 39008

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Clinico Universitario de Valencia (Site #1307)

    Valencia, 46010

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital General Universitario de Valencia (Site #1308)

    Valencia, 46014

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Spain

Australia8 sites, 8 recruiting

  • Chris O'Brien Lifehouse (Site#0302)

    Camperdown, New South Wales, 2050

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Austin Health (Site #0303)

    Heidelberg, Victoria, 3084

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Nepean Hospital (Site #0306)

    Kingswood, New South Wales, 2747

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fiona Stanley Hospital (Site#0308)

    Murdoch, Western Australia, 6150

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Peter Macallum Cancer Centre (Site#0301)

    North Melbourne, Victoria, 3051

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Gold Coast University Hospital (Site #0305)

    Southport, Queensland, 4215

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • John Flynn Private Hospital (Site#0307)

    Tugun, Queensland, 4224

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Calvary Mater Newcastle (Site#0304)

    Waratah, New South Wales, 2298

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Australia

Portugal8 sites, 8 recruiting

  • Centro Clínico Académico de Braga (Site #1506)

    Braga, 4710-243

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (Site #1503)

    Coimbra

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Instituto Português de Oncologia Lisboa (Site #1508)

    Lisbon, 1099-023

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centro Hospitalar Algarve (Site #1501)

    Portimão, 8500-338

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE (Site #1505)

    Porto, 4200-072

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centro Hospitalar Universitario de Sao Joao (Site #1507)

    Porto, 4200-319

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Unidade Local de Saude de Matosinhos, E.P.E. - Hospital Pedro Hispano (Site #1502)

    Senhora da Hora, 4464-509

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E. (Site # 1504)

    Vila Nova de Gaia, 4434-502

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Portugal

Poland7 sites, 7 recruiting

  • UNIWERSYTECKIE CENTRUM KLINICZNE (Site #1401)

    Gdansk, 80-214

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie (Site # 1405)

    Gliwice, 44-102

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Pratia Onkologia Katowice (Site #1403)

    Katowice, 40-519

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Przychodnia Lekarska Komed (Site #1407)

    Konin, 62-500

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Szpital Specjalistyczny im. L.Rydygiera w Krakowie (Site #1404)

    Krakow, 31-826

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Mazowiecki Szpital Wojewódzki im. sw. Jana Pawla II w Siedlcach Sp. z o.o. (Site #1402)

    Siedlce, 08-110

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curiee - Panstwowy Instytut (Site #1406)

    Warsaw, 02-781

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Poland

South Korea7 sites, 7 recruiting

  • Kosin University Gospel Hospital (Site # 2707)

    Busan, 49267

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • National Cancer Center (Site # 2704)

    Goyang-si, 10408

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Chonnam National University Hwasun Hospital (Site # 2705)

    Hwasun, 58128

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Seoul National University Bundang Hospital (Site # 2706)

    Seongnam, 13620

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Seoul National University Hospital (Site # 2701)

    Seoul, 3080

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • SEVERANCE HOSPITAL, YONSEI UNIVERSITY (Site # 2702)

    Seoul, 3722

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Samsung Medical Center (Site # 2703)

    Seoul, 6351

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in South Korea

Belgium6 sites, 6 recruiting

  • AZ St-Jan Brugge Oostende av (Campus Sint-Jan) (Site #1007)

    Bruges, 8000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • CHU Ambroise Paré (Site #1005)

    Mons, 7000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • CHU UCL Namur, Site Ste. Elisabeth (Site #1002)

    Namur, 5000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • CHU UCL Namur, Site Mont-Godinne (Site #1003)

    Namur, 5530

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Vitaz (Site #1001)

    Sint-Niklaas, 9100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • ZAS Augustinus (Site #1006)

    Wilrijk, 2610

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Belgium

Argentina5 sites, 5 recruiting

  • CEMIC (Site # 2301)

    Buenos Aires, C1190

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • ICM Center (Site # 2306)

    Buenos Aires, C1425

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Universitario Austral (Site # 2303)

    Pilar, B1629ODT

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Sanatorio de la Mujer (Site # 2305)

    Rosario, CP2000

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Provincial del Centenario (Site # 2302)

    Santa Fe, S2002KDT

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Argentina

Malaysia5 sites, 5 recruiting

  • Mount Miriam Cancer Hospital (Site # 2802)

    George Town, 11200

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Kuala Lumpur (Site # 2803)

    Kuala Lumpur, 50586

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University Malaya Medical centre (Site # 2805)

    Kuala Lumpur, 59100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Sarawak General Hospital (Site # 2801)

    Kuching, 93200

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hospital Pulau Pinang (Site # 2804)

    Pulau Pinang, 10450

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Malaysia

Thailand5 sites, 5 recruiting

  • Phramongkutklao Hospital (Site # 2505)

    Bangkok, 10400

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Rajavithi Hospital (Site # 2504)

    Bangkok, 10400

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital (Site # 2506)

    Chiang Mai, 50200

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Vajira Hospital (Site # 2503)

    Dusit, 10300

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Songklanagarind Hospital (Site # 2502)

    Hat Yai, 90110

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Thailand

Turkey (Türkiye)5 sites, 5 recruiting

  • Hacettepe University Medical Faculty (Site # 1201)

    Ankara, 6100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Memorial Ankara Hospital (Site # 1202)

    Ankara, 6520

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Memorial Antalya Hastanesi (Site # 1204)

    Antalya, 7020

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty (Site # 1203)

    Istanbul, 34098

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Dokuz Eylul University Medical School (Site # 1206)

    Izmir, 35330

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Turkey (Türkiye)

Israel4 sites, 4 recruiting

  • Soroka Medical Center (Site # 1901)

    Beersheba, 84101

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hadassah Medical Center (Site # 1903)

    Jerusalem, 9112001

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Rabin Medical Center (Site # 1904)

    Petah Tikva, 49100

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Sourasky Medical Center (Site # 1902)

    Tel Aviv, 6423906

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Israel

Taiwan4 sites, 4 recruiting

  • Changhua Christian Medical Foundation Changhua Christian Hospital (Site # 2602)

    Changhua, 50006

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (Site # 2601)

    Kaohsiung City, 807

    Principal Investigator, 617-468-421, FORTIFI_inquiries@bicara.com

    Recruiting

  • China Medical University Hospital (CMUH) (Site # 2603)

    Taichung, 40447

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • National Taiwan University Hospital (Site # 2604)

    Taipei, 10002

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Taiwan

Canada3 sites, 3 recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame (Site #0203)

    Montreal, Quebec, H2X 0C1

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Sunnybrook Health Sciences Centre (Site # 0204)

    Toronto, M4N 3M5

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • BC Cancer - Vancouver (Site #0202)

    Vancouver, British Columbia, V5Z 4E6

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Canada

Ireland3 sites, 3 recruiting

  • Cork University Hospital - Consultants Private Clinic (Site # 0603)

    Cork, T12 DC4A

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Trinity College Dublin (TCD) - St. James's Hospital (SJH) (Site #0602)

    Dublin, D08 NHY1

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Beaumont Hospital (Site #0601)

    Dublin, D09 V2N0

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Ireland

Switzerland3 sites, 3 recruiting

  • HFR Fribourg Kantonsspital Fribourg (Site # 1803)

    Fribourg, 1752

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Hopitaux Universitaires de Geneve (Site # 1802)

    Geneva, 1205

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Centre Hospitalier Universitaire Vaudois (CHUV) (Site # 1801)

    Lausanne, 1011

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Switzerland

Austria2 sites, 2 recruiting

  • Hematology and Medical Oncology, Paracelsus Medical University (Site #1602)

    Salzburg, 5020

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Medical University Vienna (Site #1601)

    Vienna, 1090

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Austria

Czechia2 sites, 2 recruiting

  • Fakultni Nemocnice Hradec Kralove (FNHK) (Site # 2101)

    Hradec Králové, 500 03

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Fakultni nemocnice Motol a Homolka (Site #2102)

    Prague, 15006

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Czechia

Greece2 sites, 2 recruiting

  • U.G.H. ATTIKON - General Hospital of West Attica "H AGIA VARVARA" (Site # 1701)

    Athens, 12461

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • University General Hospital of Larissa (Site # 1702)

    Larissa, 41110

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Greece

India2 sites, 2 recruiting

  • Meenakshi Mission Hospital & Research Centre (Site # 3003)

    Madurai, 625107

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Nirmal Hospital (Site # 3002)

    Sūrat, 395004

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in India

New Zealand2 sites, 2 recruiting

  • Christchurch Hospital NZ (Site #0401)

    Christchurch, 8011

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • Rotorua Hospital (Site#0402)

    Rotorua, 3010

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in New Zealand

Singapore2 sites, 2 recruiting

  • Tan Tock Seng Hospital (Site # 2902)

    Novena, 308433

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

  • National Cancer Centre Singapore (Site # 2901)

    Singapore, 168583

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Singapore

Japan1 site, 1 recruiting

  • Cancer Institute Hospital of JFCR (Site # 3107)

    Kōtoku, 135-8550

    Principal Investigator, 617-468-4219, FORTIFI_inquiries@bicara.com

    Recruiting

Other trials in Japan

About this study

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

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).

Read the detailed description

The mechanism of action of ficerafusp alfa involves dual targeting of two cancer targets, EGFR and TGF-β, which are known to drive solid tumor growth and metastasis.

Phase 2 of the study will identify an optimal biologic dose (OBD) supported by the safety, tolerability, PK, PD, and efficacy data of ficerafusp alfa. In this part, eligible subjects will be randomized to one of three treatment arms at a 1:1:1 ratio:

  • Arm A: ficerafusp alfa 1500 mg once weekly (QW) + pembrolizumab 200 mg every three weeks (Q3W).
  • Arm B: ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W.
  • Arm C (control): placebo QW + pembrolizumab 200 mg Q3W.

The primary objective for the phase 3 portion is to compare the efficacy in subjects treated with ficerafusp alfa at the selected OBD in combination with pembrolizumab versus placebo with pembrolizumab. Eligible subjects will be randomized 2:1 in the treatment versus control arm during the phase 3 portion.

Being tested
Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), Placebo
Keywords
Phase 2/3, Ficerafusp alfa, BCA101, Recurrent Head and Neck Squamous Cell Carcinoma (R HNSCC), Metastatic Head and Neck Squamous Cell Carcinoma (M HNSCC), Pembrolizumab, EGFR, TGF-beta, HNSCC, PD-L1+, Head and Neck cancer, Oral Cavity, Oropharynx, Larynx, Hypopharynx
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Camurati-Engelmann Syndrome, Head and Neck Neoplasms, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ficerafusp alfaDrug

    Investigational

  • Pembrolizumab (KEYTRUDA®)Drug

    Immunotherapy agent used in combination with investigational agent

  • PlaceboDrug

    Placebo Control

Study groups in NCT06788990
Study groupRoleWhat they receive
Phase 2 Arm AExperimentalficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W)
Receives: Drug: Ficerafusp alfa; Drug: Pembrolizumab (KEYTRUDA®)
Phase 2 Arm BExperimentalficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W
Receives: Drug: Ficerafusp alfa; Drug: Pembrolizumab (KEYTRUDA®)
Phase 2 Arm CPlacebo comparatorplacebo QW + pembrolizumab 200 mg Q3W
Receives: Drug: Pembrolizumab (KEYTRUDA®); Drug: Placebo
Phase 3 OBD ArmExperimentalficerafusp alfa OBD + pembrolizumab 200 mg Q3W
Receives: Drug: Ficerafusp alfa; Drug: Pembrolizumab (KEYTRUDA®)
Phase 3 Arm CPlacebo comparatorplacebo QW + pembrolizumab 200 mg Q3W
Receives: Drug: Pembrolizumab (KEYTRUDA®); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.

    To assess safety and tolerability of ficerafusp alfa with pembrolizumab.

    Measured: Up to 30 days post end of treatment for TEAEs (90 days for SAEs).

  2. Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)

    ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.

    Measured: Approximately 1 year.

  3. Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.

    ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.

    Measured: Approximately 2 years.

  4. Phase 3 - Overall Survival (OS)

    OS: Defined as the time from the randomization to death due to any cause.

    Measured: Approximately 3 years.

Secondary outcomes (11)

  1. Phase 2 - Duration of Response (DOR) per RECIST 1.1 by BICR.

    DOR: For subjects who demonstrated CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first, per RECIST 1.1 by BICR.

    Measured: Approximately 1 year.

  2. Phase 3 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.

    To assess safety and tolerability of ficerafusp alfa with pembrolizumab.

    Measured: Up to 30 days post end of treatment for TEAEs (90 days for SAEs).

  3. Phase 3 - Progression-free survival (PFS) per RECIST 1.1 by BICR.

    PFS: Defined as the time from randomization to the first documented PD per RECIST 1.1 as determined by BICR or death due to any cause, whichever occurs first.

    Measured: Approximately 3 years.

  4. Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.

    ORR: Defined as confirmed CR + PR per RECIST 1.1 by BICR. (FAS).

    Measured: Approximately 3 years.

  5. Phase 3 - Duration of Response (DOR) per RECIST 1.1 by BICR.

    DOR: For subjects who demonstrated CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first per RECIST 1.1 by BICR.

    Measured: Approximately 3 years.

  6. Phase 3 - Clinical Benefit Rate (CBR) per RECIST 1.1 by BICR.

    Clinical Benefit Rate: For subject who demonstrated CR + PR + SD>6 months per RECIST 1.1 by BICR.

    Measured: Approximately 3 years.

  7. Phase 3 - ORR, per RECIST 1.1 by investigator's assessment.

    ORR, per RECIST 1.1 as determined by investigator's assessment.

    Measured: Approximately 3 years.

  8. Phase 3 - DOR, per RECIST 1.1 by investigator's assessment.

    DOR, per RECIST 1.1 as determined by investigator's assessment.

    Measured: Approximately 3 years.

  9. Phase 3 - PFS, per RECIST 1.1 by investigator's assessment.

    PFS, per RECIST 1.1 as determined by investigator's assessment.

    Measured: Approximately 3 years.

  10. Phase 3 - 14. Time to deterioration (TTD) in global health status measured by the EORTC QLQ C30 items for global health status and quality of life scale (item 29/30)

    To evaluate TTD in global health status/quality of life in subjects treated with ficerafusp alfa in combination with pembrolizumab versus placebo plus pembrolizumab.

    TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in QoL using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function.

    Measured: Approximately 3 years.

  11. Phase 3 - Time to deterioration (TTD) in pain measured by the EORTC HN 35 (items 31-34) pain domain.

    To evaluate TTD in pain in subjects treated with ficerafusp alfa in combination with pembrolizumab versus placebo plus pembrolizumab.

    TTD defined as the time from first dose (baseline) to change in pain score by 10-point from baseline, using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core Head and Neck Module (EORTC HN35). A higher score indicates a higher level of symptom burden.

    Measured: Approximately 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start28 Jan 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06788990
Sponsor's protocol ID
BCA101X301
Other IDs
2024-519654-37-00
Acronym
FORTIFI-HN01
Status last verified
Oct 2026
First submitted
10 Jan 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ficerafusp alfa and Pembrolizumab (KEYTRUDA®) in people with Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by Bicara Therapeutics at 231 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in United States, Brazil, Italy, Germany, United Kingdom and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Affairs (1-617-468-4219, FORTIFI_inquiries@bicara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation. (time frame: Up to 30 days post end of treatment for TEAEs (90 days for SAEs).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06788990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in