FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
NCT ID: NCT06788990
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
650 participants
INTERVENTIONAL
2025-01-28
2029-07-31
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase 2 Arm A
ficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W)
Ficerafusp alfa
Investigational
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Phase 2 Arm B
ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W
Ficerafusp alfa
Investigational
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Phase 2 Arm C
placebo QW + pembrolizumab 200 mg Q3W
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Placebo
Placebo Control
Phase 3 OBD Arm
ficerafusp alfa OBD + pembrolizumab 200 mg Q3W
Ficerafusp alfa
Investigational
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Phase 3 Arm C
placebo QW + pembrolizumab 200 mg Q3W
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Placebo
Placebo Control
Interventions
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Ficerafusp alfa
Investigational
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Placebo
Placebo Control
Eligibility Criteria
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Inclusion Criteria
* 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 (by PD-L1 IHC 22C3 pharmDx assay).
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Bicara Therapeutics
INDUSTRY
Responsible Party
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Locations
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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 #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 #0146
Rochester, Minnesota, United States
Site #0119
Hackensack, New Jersey, 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#0134
Charlottesville, Virginia, United States
Site #0129
Richmond, Virginia, United States
Site #0125
Seattle, Washington, United States
Site#0120
Vancouver, Washington, United States
Site #0141
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 #0202
Vancouver, British Columbia, Canada
Site #0203
Montreal, Quebec, Canada
Site #0401
Christchurch, , New Zealand
Site#0402
Rotorua, , New Zealand
Site #1506
Braga, , Portugal
Site #0504
Aberdeen, , United Kingdom
Site #0505
London, , United Kingdom
Site # 0501
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-519654-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
BCA101X301
Identifier Type: -
Identifier Source: org_study_id