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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
11/05/2025

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
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
Secondary ID [1] 0 0
2024-519654-37-00
Secondary ID [2] 0 0
BCA101X301
Universal Trial Number (UTN)
Trial acronym
FORTIFI-HN01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Head and Neck Squamous Cell Carcinoma 0 0
Recurrent Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
Timepoint [1] 0 0
Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
Primary outcome [2] 0 0
Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
Timepoint [2] 0 0
Approximately 1 year.
Primary outcome [3] 0 0
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
Timepoint [3] 0 0
Approximately 2 years.
Primary outcome [4] 0 0
Phase 3 - Overall Survival (OS)
Timepoint [4] 0 0
Approximately 3 years.
Secondary outcome [1] 0 0
Phase 2 - Duration of Response (DOR) per RECIST 1.1 by BICR.
Timepoint [1] 0 0
Approximately 1 year.
Secondary outcome [2] 0 0
Phase 3 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
Timepoint [2] 0 0
Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
Secondary outcome [3] 0 0
Phase 3 - Progression-free survival (PFS) per RECIST 1.1 by BICR.
Timepoint [3] 0 0
Approximately 3 years.
Secondary outcome [4] 0 0
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
Timepoint [4] 0 0
Approximately 3 years.
Secondary outcome [5] 0 0
Phase 3 - Duration of Response (DOR) per RECIST 1.1 by BICR.
Timepoint [5] 0 0
Approximately 3 years.
Secondary outcome [6] 0 0
Phase 3 - Clinical Benefit Rate (CBR) per RECIST 1.1 by BICR.
Timepoint [6] 0 0
Approximately 3 years.
Secondary outcome [7] 0 0
Phase 3 - ORR, per RECIST 1.1 by investigator's assessment.
Timepoint [7] 0 0
Approximately 3 years.
Secondary outcome [8] 0 0
Phase 3 - DOR, per RECIST 1.1 by investigator's assessment.
Timepoint [8] 0 0
Approximately 3 years.
Secondary outcome [9] 0 0
Phase 3 - PFS, per RECIST 1.1 by investigator's assessment.
Timepoint [9] 0 0
Approximately 3 years.
Secondary outcome [10] 0 0
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)
Timepoint [10] 0 0
Approximately 3 years.
Secondary outcome [11] 0 0
Phase 3 - Time to deterioration (TTD) in pain measured by the EORTC HN 35 (items 31-34) pain domain.
Timepoint [11] 0 0
Approximately 3 years.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2029
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site#0304 - Waratah
Recruitment hospital [2] 0 0
Site#0307 - Tugun
Recruitment hospital [3] 0 0
Site#0301 - North Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4224 - Tugun
Recruitment postcode(s) [3] 0 0
3051 - North Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bicara Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carrie Smith, Senior Director, Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
1-617-468-4219
Fax 0 0
Email 0 0
[email protected]
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