Informations générales (source: ClinicalTrials.gov)
A Phase II Study of Ficerafusp Alfa (BCA 101) in Combination With Nivolumab in Platinum Refractory Head and Neck Squamous Cell Carcinoma Patients Who Progressed Within 6 Months After Multimodal Treatment for Locally Advanced Disease ( BICARA)
Interventional
Phase 2
Groupe Oncologie Radiotherapie Tete et Cou (Voir sur ClinicalTrials)
mars 2026
décembre 2030
06 octobre 2026
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 18/08/2026 13:10:02 | Contacter | ||
Critères
Tous
- 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).
- Local, regional or metastatic progression within 6 months after the last dose of
platinum in a multimodal strategy for locally advanced stage, not amenable to
salvage surgery in case of local or regional progression.
Specification regarding inclusion criterion no. 05 : Progression is not assessed as per
RECIST. Any of the following will be considered as progression:
- A positive biopsy 3 months after the end of radiotherapy given with curative intent
- Appearance of any new lesion (e.g.: metastases or lymph nodes)
- Any increase in tumor size
- Any persisting tumor (confirmed with a biopsy) not amenable to salvage surgery
- For OPSCC patients, a pathological report determination of human papillomavirus
(HPV) status by p16 expression must be p16 negative -Measurable tumor lesion(s)
assessed by H&N-computed tomography scan (CT-scan) or magnetic resonance imaging
(MRI), based on RECIST v 1.1 (see Appendix 3). Tumor lesions situated in a
previously irradiated area are considered measurable if progression has been
demonstrated.
Exclusion Criteria:
- 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.
- Patients having received prior therapy with anti-PD1, anti-PD-L1 (or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint
pathways).
- Known to be diagnosed and/or treated for any other additional malignancy within 2
years prior to registration/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 defined as follows: Stage T1 up to
T2a with a Gleason score ≤6 and prostatic specific antigen <10 ng/mL either treated
with definitive intent or untreated in active surveillance that has been stable for
the past year prior to registration/randomization. Other exceptions may be
considered with the Sponsor's consultation. The time requirement for no malignancy
for 2 years does not apply to the cancer for which a patient is enrolled in the
study.
- Any of the following <6 months before starting study treatment: ST-elevation
myocardial infarction, severe/unstable angina, uncontrolled cardiac ventricular
arrythmia, coronary/peripheral artery bypass graft or stent, cerebrovascular
accident/stroke less than 6 months prior to enrollment or NYHA Class III/IV
congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically
stable can enroll if they are on a stable dose of anticoagulants for at least 3
months.
- Serious systemic infection (bacterial, viral, or fungal) within 4 weeks before first
dose of study treatment, or active systemic infection requiring either
hospitalization or parenteral anti-infective therapy within 2 weeks before first
dose of study treatment.
- History of (non-infectious) pneumonitis/ interstitial lung disease or has current
pneumonitis/ Interstitial lung disease.
- Active central nervous system (CNS) metastases or carcinomatous meningitis. Known
active central nervous system metastases, history of spinal cord compression from
tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease
are excluded. Patients with a history of treated central nervous system metastases
(by surgery or radiation therapy) may be eligible if central nervous system
metastases have been stable for at least 4 weeks, i.e., without evidence of
progression by repeat imaging and without requirement of steroid treatment for at
least 14 days prior to first dose of study treatment.
- History of uncontrolled seizures, CNS disorders or psychiatric disability judged by
the investigator to be clinically significant, precluding informed consent, or
interfering with compliance.