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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06788990
Registration number
NCT06788990
Ethics application status
Date submitted
10/01/2025
Date registered
23/01/2025
Date last updated
30/05/2025
Titles & IDs
Public title
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
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Scientific 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
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Secondary ID [1]
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2024-519654-37-00
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Secondary ID [2]
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BCA101X301
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Universal Trial Number (UTN)
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Trial acronym
FORTIFI-HN01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Head and Neck Squamous Cell Carcinoma
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Recurrent Head and Neck Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ficerafusp alfa
Treatment: Drugs - Pembrolizumab (KEYTRUDA®)
Treatment: Drugs - Placebo
Experimental: Phase 2 Arm A - ficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W)
Experimental: Phase 2 Arm B - ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W
Placebo comparator: Phase 2 Arm C - placebo QW + pembrolizumab 200 mg Q3W
Experimental: Phase 3 OBD Arm - ficerafusp alfa OBD + pembrolizumab 200 mg Q3W
Placebo comparator: Phase 3 Arm C - placebo QW + pembrolizumab 200 mg Q3W
Treatment: Drugs: Ficerafusp alfa
Investigational
Treatment: Drugs: Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Treatment: Drugs: Placebo
Placebo Control
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
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Assessment method [1]
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To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
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Timepoint [1]
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Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
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Primary outcome [2]
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Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
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Assessment method [2]
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ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
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Timepoint [2]
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Approximately 1 year.
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Primary outcome [3]
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Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
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Assessment method [3]
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ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
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Timepoint [3]
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Approximately 2 years.
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Primary outcome [4]
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Phase 3 - Overall Survival (OS)
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Assessment method [4]
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OS: Defined as the time from the randomization to death due to any cause.
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Timepoint [4]
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Approximately 3 years.
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Secondary outcome [1]
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Phase 2 - Duration of Response (DOR) per RECIST 1.1 by BICR.
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately 1 year.
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Secondary outcome [2]
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Phase 3 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
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Assessment method [2]
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To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
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Timepoint [2]
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Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
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Secondary outcome [3]
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Phase 3 - Progression-free survival (PFS) per RECIST 1.1 by BICR.
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Assessment method [3]
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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.
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Timepoint [3]
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Approximately 3 years.
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Secondary outcome [4]
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Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
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Assessment method [4]
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ORR: Defined as confirmed CR + PR per RECIST 1.1 by BICR. (FAS).
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Timepoint [4]
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Approximately 3 years.
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Secondary outcome [5]
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Phase 3 - Duration of Response (DOR) per RECIST 1.1 by BICR.
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Assessment method [5]
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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.
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Timepoint [5]
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Approximately 3 years.
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Secondary outcome [6]
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Phase 3 - Clinical Benefit Rate (CBR) per RECIST 1.1 by BICR.
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Assessment method [6]
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Clinical Benefit Rate: For subject who demonstrated CR + PR + SD\>6 months per RECIST 1.1 by BICR.
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Timepoint [6]
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Approximately 3 years.
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Secondary outcome [7]
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Phase 3 - ORR, per RECIST 1.1 by investigator's assessment.
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Assessment method [7]
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ORR, per RECIST 1.1 as determined by investigator's assessment.
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Timepoint [7]
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Approximately 3 years.
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Secondary outcome [8]
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Phase 3 - DOR, per RECIST 1.1 by investigator's assessment.
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Assessment method [8]
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DOR, per RECIST 1.1 as determined by investigator's assessment.
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Timepoint [8]
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Approximately 3 years.
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Secondary outcome [9]
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Phase 3 - PFS, per RECIST 1.1 by investigator's assessment.
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Assessment method [9]
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PFS, per RECIST 1.1 as determined by investigator's assessment.
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Timepoint [9]
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Approximately 3 years.
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Secondary outcome [10]
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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)
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Assessment method [10]
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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.
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Timepoint [10]
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Approximately 3 years.
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Secondary outcome [11]
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Phase 3 - Time to deterioration (TTD) in pain measured by the EORTC HN 35 (items 31-34) pain domain.
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Assessment method [11]
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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.
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Timepoint [11]
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Approximately 3 years.
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Eligibility
Key inclusion criteria
* 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 (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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Disease suitable for local therapy administered with curative intent.
* Prior treatment with anti-TGFß 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.
Other Inclusion/Exclusion criteria may apply as defined in the protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2029
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Actual
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Sample size
Target
650
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Site#0304 - Waratah
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Recruitment hospital [2]
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Site#0307 - Tugun
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Recruitment hospital [3]
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Site#0301 - North Melbourne
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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4224 - Tugun
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Recruitment postcode(s) [3]
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3051 - North Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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Colorado
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Delaware
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United States of America
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Florida
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United States of America
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Iowa
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Kentucky
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Massachusetts
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New Jersey
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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State/province [17]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bicara Therapeutics
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-ß). 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).
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Trial website
https://clinicaltrials.gov/study/NCT06788990
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Fax
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Email
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Contact person for public queries
Name
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Carrie Smith, Senior Director, Clinical Operations
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Address
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Phone
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1-617-468-4219
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06788990
Download to PDF