2025-521437-88-00招募中2 期
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)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 121
- 试验地点
- 13
- 主要终点
- 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
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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 : 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
- •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.
排除标准
- •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).
- •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.
- •Subjects having received prior systemic treatment for metastatic or recurrent disease
- •Subjects having received prior treatment with anti-EGFR antibody.
- •Subjects having received prior treatment with anti-TGF-β therapy.
- •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)
- •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.
- •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.
研究组 & 干预措施
Ficerafusp Alfa
Test
干预措施: Ficerafusp Alfa (Drug)
OPDIVO 10 mg/mL concentrate for solution for infusion.
Comparator
干预措施: OPDIVO 10 mg/mL concentrate for solution for infusion. (Drug)
结局指标
主要结局
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
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
次要结局
- 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
- 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
- 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
- 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
研究者
Dr Caroline EVEN
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (13)
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