Phase II study of ficerafusp alfa in combination with nivolumab in patients with platinum-refractory head and neck squamous cell carcinoma who progressed within 6 months of multimodality therapy for locally advanced disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-03-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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.

Secondary objectives 5

1. To compare the duration of response between two arms.
2. To compare the progression free survival (PFS) between two arms.
3. To compare the overall survival (OS) between two arms
4. To evaluate and compare treatment compliance between arms
5. To evaluate and compare adverse events experienced by patients in both arms of treatment using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Conditions and MedDRA coding

head and neck squamous cell carcinoma

Regulatory references

Plan to share IPD

Yes

IPD plan description

The study will be conducted in Europe with GORTEC as sponsor. Pseudonymized participant data may be shared with the owner of the product ficerasup alfa.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient is >18 years, ≤75 years of age on the day the ICF is signed.
2. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
3. Histologically or cytologically confirmed squamous cell carcinoma of head and neck (HNSCC). Eligible primary tumor locations are oral cavity, larynx hypopharynx, or oropharynx (OPSCC).
4. 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 : The pProgression is not assessed as per RECIST. and Any of the following that will be considered as a progression any of the following items : o A positive biopsy 3 months after the end of radiotherapy given with curative intent o Appearance of any new lesion (exe.g.: metastases or lymph nodes) o Any increase in tumor size o Any persisting tumor (confirmed with a biopsy) not amenable to salvage surgery
5. For OPSCC patients, a pathological report determination of human papillomavirus (HPV) status by p16 expression must be p16 negative
6. 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 12

1. 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).
2. Subjects having received prior systemic treatment for metastatic or recurrent disease
3. Subjects having received prior treatment with anti-EGFR antibody.
4. Subjects having received prior treatment with anti-TGF-β therapy.
5. Subjects 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)
6. Patient who 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 or at least 4 weeks if half live of the agent received is not known before enrollment.
7. 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
8. 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
9. 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.
10. History of (non-infectious) pneumonitis/ interstitial lung disease or has current pneumonitis/ Interstitial lung disease.
11. 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.
12. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 4

1. Duration of objective response (DOR) is defined as the time (months) between first occurrence of CR or PR to disease progression or death, whichever comes first. Only those patients with confirmed objective responses of CR or PR will be included in this analysis. Censoring rules for patients who do not experience progression (PD) or death will be described in the SAP
2. Progression-free survival (PFS) is defined as the time (months) from randomization (or start of treatment in the run-in phase) to the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first. Censoring rules for patients who do not experience PD or death will be described in the SAP
3. Overall survival (OS) is defined as the time (months) between randomization (or start of treatment in the run-in phase) and death of any cause or date of last FU for patients alive
4. Incidence and severity of adverse events, serious adverse events and laboratory abnormalities as graded by the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCI-CTCAE) v 5.0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Groupe Oncologie Radiotherapie Tete Cou

Sponsor organisation

Groupe Oncologie Radiotherapie Tete Cou

Address

4 B Rue Emile Zola

City

Tours

Postcode

37000

Country

France

Scientific contact point

Organisation

Groupe Oncologie Radiotherapie Tete Cou

Contact name

Dr Caroline EVEN

Public contact point

Organisation

Groupe Oncologie Radiotherapie Tete Cou

Contact name

Laura SINIGAGLIA

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications