This is a multicenter study comprising two phases: a run-in phase, including only patients receiving ficerafusp alfa and nivolumab, and a randomized phase, which corresponds to a randomized, open-label, phase II comparative study.
The primary objective is to compare the objective response rate (ORR) of patients with platinum refractory HNSCC with progressive disease within the 6 months after multimodal curative treatment treated with ficerafusp alfa (BCA 101) and nivolumab versus nivolumab alone.
There is a strong medical justification for combining ficerafusp alfa with nivolumab (anti-PD-1) to provide additional clinical benefit to patients with platinum-refractory HNSCC who are progressing within 6 months of multimodal treatment for locally advanced disease.
In the Run-in phase, patients will receive the following treatment regimens according to the study intervention plan:
Combination of Ficerafusp alfa + Nivolumab
* Ficerafusp alfa 1500 mg every week * Nivolumab 240 mg every 2 weeks
In the randomized trial:
* ARM A Combination of Ficerafusp alfa + Nivolumab Ficerafusp alfa 1500 mg every week Nivolumab 240 mg every 2 weeks * ARM B Nivolumab monotherapy Nivolumab 240 mg every 2 weeks
Patient or legally authorized representative, if applicable, has signed and dated informed consent form (ICF) indicating that the patient (or legally authorized representative, if applicable) has been informed of all the pertinent aspects of the study prior to enrollment and the patient must be willing to comply with all study procedures for the duration of the study.
Patient is >18 years, ≤75 years of age on the day the ICF is signed.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (see Appendix 1).
Histologically or cytologically confirmed squamous cell carcinoma of head and neck (HNSCC). Eligible primary tumor locations are oral cavity, larynx hypopharynx, or oropharynx (OPSCC).
Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity or salivary gland, thyroid or parathyroid gland pathologies, skin, squamous cell carcinoma of unknown primary or non-squamous histologies (e.g., mucosal melanoma).
Patients having received prior systemic treatment for metastatic or recurrent disease.
Patients having received prior treatment with anti-EGFR antibody.
Patients having received prior treatment with anti-TGF-β therapy.
Parallel
Ficerafusp alfa
DrugFicerafusp alfais a bifunctional recombinant fusion protein consisting of a chimeric anti-EGFR mAb and human TGFβRII-ECD
Nivolumab
DrugNivolumab is a monoclonal antibody that binds to and blocks the programmed cell death 1 receptor. It is used to treat certain cancers.
Objective response rate (ORR)
the objective response rate (ORR) which is defined as the proportion of patients with a confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by the investigator according to RECIST criteria 1.1.
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Groupe Oncologie Radiotherapie Tete et Cou
Lead sponsor
Bicara Therapeutics
Collaborator
