Ficerafusp Alfa + Pembrolizumab for Head and Neck Cancer (FORTIFI-HN01 Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Bicara Therapeutics
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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).
Is the combination of Ficerafusp Alfa and Pembrolizumab safe for humans?
Pembrolizumab, used in treating head and neck cancer, generally has a manageable safety profile, with common side effects like diarrhea, thyroid issues, and skin rash, and rare severe lung inflammation. However, specific safety data for Ficerafusp Alfa in combination with Pembrolizumab is not provided in the available research.
124610What data supports the effectiveness of the drug Ficerafusp Alfa + Pembrolizumab for head and neck cancer?
Research shows that pembrolizumab, one of the drugs in the combination, is effective in treating head and neck cancer, especially in patients with high levels of PD-L1, a protein that helps cancer cells hide from the immune system.
135910What makes the drug Ficerafusp Alfa + Pembrolizumab unique for head and neck cancer?
Ficerafusp Alfa combined with Pembrolizumab is unique because it potentially offers a novel approach by combining two different mechanisms: Ficerafusp Alfa's specific action (details not provided) with Pembrolizumab's ability to block PD-1, a protein that helps cancer cells evade the immune system. This combination could enhance the immune system's ability to fight head and neck cancer compared to using Pembrolizumab alone.
157810Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications like corticosteroids or immunosuppressive drugs, you may need to stop them 7 days before starting the trial treatment.
Eligibility Criteria
This trial is for adults with PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who haven't been treated before. Participants must meet certain health standards but specific inclusion and exclusion criteria are not provided here.Inclusion Criteria
I am 18 years old or older.
My cancer is confirmed in the head or neck and has spread.
My cancer tests positive for PD-L1.
I am fully active or can carry out light work.
Exclusion Criteria
My condition can be treated with the goal of curing it.
I have been treated with anti-TGFβ therapy before.
I've had a bad reaction to certain cancer drugs before.
I have brain metastases or a history of cancer affecting my spinal cord or meninges.
I have active chronic hepatitis B and am not on antiviral therapy.
I have hepatitis C and haven't completed or responded to treatment.
I have waited the required time after my last investigational drug or study before joining this one.
I haven't taken high doses of steroids or immunosuppressants in the last week.
Participant Groups
The study tests the effectiveness of a new drug called Ficerafusp alfa, which targets EGFR and TGF-β, in combination with an existing cancer drug Pembrolizumab. It's compared to using Pembrolizumab with a placebo to see if there's any improvement.
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3 OBD ArmExperimental Treatment2 Interventions
ficerafusp alfa OBD + pembrolizumab 200 mg Q3W
Group II: Phase 2 Arm BExperimental Treatment2 Interventions
ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W
Group III: Phase 2 Arm AExperimental Treatment2 Interventions
ficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W)
Group IV: Phase 2 Arm CPlacebo Group2 Interventions
placebo QW + pembrolizumab 200 mg Q3W
Group V: Phase 3 Arm CPlacebo Group2 Interventions
placebo QW + pembrolizumab 200 mg Q3W
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Site#104Charleston, SC
Site#0126Nashville, TN
Site#0117Cincinnati, OH
Site#0104Charleston, SC
More Trial Locations
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Who is running the clinical trial?
Bicara TherapeuticsLead Sponsor
References
Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. [2022]Patients with recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options. We aimed to assess the safety, tolerability, and antitumour activity of pembrolizumab, a humanised anti-programmed death receptor 1 (PD-1) antibody, in patients with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck.
Pembrolizumab and its use in the treatment of recurrent or metastatic head and neck cancer. [2019]Until recently, palliative options for the treatment of platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have been cytotoxic chemotherapy and EGFR inhibitors. These agents offer limited efficacy with substantial toxicity. The development of novel immune checkpoint inhibitors has challenged the standard treatment. Pembrolizumab is a potent and highly selective humanized monoclonal antibody that blocks the interaction between PD-1, an immune checkpoint receptor and its ligands PD-L1 and -2. In August 2016, the US FDA approved the use of pembrolizumab in R/M HNSCC following disease progression on or after platinum-containing chemotherapy. This review highlights the pharmacology, therapeutic efficacy and tolerability data relevant to the use of pembrolizumab for the treatment of R/M HNSCC. Readers will gain greater insight into the HNSCC tumor microenvironment, available biomarkers, and learn about important clinical considerations associated with the use of pembrolizumab and similar immune checkpoint inhibitors.
Pembro Ups Survival in PD-L1-positive HNSCC. [2019]In a phase III trial, first-line treatment with single-agent pembrolizumab led to deep and durable responses among patients with head and neck tumors that expressed high levels of PD-L1.
Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. [2019]There are few effective treatment options for patients with recurrent or metastatic head-and-neck squamous cell carcinoma. Pembrolizumab showed antitumour activity and manageable toxicity in early-phase trials. We aimed to compare the efficacy and safety of pembrolizumab versus standard-of-care therapy for the treatment of head-and-neck squamous cell carcinoma.
Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. [2021]Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.
Safety evaluation of pembrolizumab for treating recurrent head and neck squamous cell carcinoma. [2022]Programmed death 1 (PD-1) blockade has changed the therapeutic landscape of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) with convincing overall response rates and overall survival benefits when compared to chemotherapy alone. The toxicity profile of pembrolizumab appears to be similar to that of other PD-1 or PD-L1 inhibitors, with frequent diarrhea, hypothyroidism or cutaneous rash cases, and rare cases of grade 3 to 5 pneumonitis.
Safety and Efficacy of Pembrolizumab With Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase IB Study. [2022]Pembrolizumab is a humanized monoclonal antibody that blocks interaction between programmed death receptor-1 (PD-1) and its ligands (PD-L1, PD-L2). Although pembrolizumab is approved for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), its role in the management of locally advanced (LA) disease is not defined. We report a phase IB study evaluating the safety and efficacy of adding pembrolizumab to cisplatin-based chemoradiotherapy in patients with LA HNSCC.
Programmed Death Ligand-1 Combined Positive Score Concordance and Interrater Reliability in Primary Tumors and Synchronous Lymph Node Metastases in Resected Cases of p16+ Oropharyngeal Squamous Cell Carcinoma. [2023]Pembrolizumab is used in patients with metastatic head and neck squamous cell carcinoma contingent upon the programmed death ligand-1 (PD-L1) combined positive score (CPS).
Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. [2023]Pembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048. Post hoc analysis of long-term efficacy and progression-free survival on next-line therapy (PFS2) is presented.
Safety outcomes of pembrolizumab with platinum agent chemotherapy combined with 5-fluorouracil or taxane derivative in head and neck cancer. [2023]For patients with metastatic head and neck squamous cell cancer (HNSCC), the outcomes of pembrolizumab in combination with a platinum agent and taxane as first-line therapy remain unknown. The purpose of this study is to characterize the impact of substituting the 5-fluorouracil (5-FU) backbone for a taxane in this chemoimmunotherapy regimen on safety/tolerability and survival outcomes.