RecruitingPhase 2Phase 3NCT06788990

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 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

Sponsor

Bicara Therapeutics

Enrollment

650 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding ficerafusp alfa (BCA101) — a drug that targets two pathways the cancer uses to evade the immune system — to the standard immunotherapy drug pembrolizumab improves outcomes in people with recurrent or metastatic head and neck squamous cell cancer (a cancer in the mouth, throat, or voice box) that has a certain immune marker. **You may be eligible if...** - You are 18 years or older - You have head and neck squamous cell cancer in the oral cavity, throat (hypopharynx, larynx, or oropharynx), confirmed by tissue test - Your cancer is recurrent (came back) or has spread to other parts of the body (metastatic), and you have not yet received treatment for this stage - Your tumor tests positive for a marker called PD-L1 (CPS score of 1 or higher) - If your cancer is in the tonsil or base of tongue area (oropharynx), it must be HPV-negative - You have measurable disease on a scan **You may NOT be eligible if...** - Your cancer is in the sinuses (paranasal sinuses) or nasopharynx - You have had prior systemic treatment for recurrent or metastatic disease - You completed prior treatment for earlier-stage disease less than 6 months ago - Your tumor does not have PD-L1 expression (CPS below 1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFicerafusp alfa

Investigational

DRUGPembrolizumab (KEYTRUDA®)

Immunotherapy agent used in combination with investigational agent

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06788990

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