2023-510558-18-00招募中2 期
Randomized Phase 2 trial of induction treatment of anti-PD-1 pucotenlimab and EGFR-ADC MRG003 or EGFR-ADC alone followed by chemoradiotherapy in locally advanced head and neck squamous cell carcinoma (LA-SCCHN).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 18
- 主要终点
- Best objective response rate evaluated by the investigators with head and neck radiological imaging according to RECIST version 1.1 criteria at the end of induction phase of EGFR-ADC MRG003 + anti-PD-1 Pucotenlimab or EGFR-ADC MRG003 alone (21 ± 7 days after the Day 1 of last cycle of induction treatment). Objective response (OR) includes complete and partial response
研究概览
简要总结
To compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti-PD-1 Pucotenlimab versus EGFR-ADC alone before chemoradiotherapy.
入排标准
- 年龄范围
- 18-64 years 至 —（Old, Adult）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, ≤ 75 years
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Histologically confirmed diagnosis in previously untreated LA-SCCHN patients suitable for definitive CRT : Stage III, IVA or IVB for oral cavity, hypopharynx, larynx or oropharynx (p16 negative) according to the American Joint Committee on Cancer [AJCC]/TNM Staging System, 8th Ed.) Or Irrespective of tobacco consumption: T3-T4/N1-N3 p16 positive oropharyngeal squamous cell carcinoma (OPSCC) (p16 protein overexpression assessed by immunohistochemistry). Or Only if tobacco consumption ≥ 20 pack - years: T1-T2/N1-N3 or T3-T4/N0 p16 positive OPSCC.
- •Evaluable tumor burden assessed by H&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1
- •Patients eligible to cisplatin-based chemotherapy
- •No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCI-CTCAE v.5).
- •Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization: a. Polynuclear neutrophils >1.5 x 109/L b. Platelets > 100 x 109/L c. Hemoglobin > 9.0 g/dL d. ALAT/ASAT< 3.0 x ULN e. Total bilirubin < 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL) f. Glomerular filtration rate ≥ 50 mL/min/1.73m² (using the CKD-EPI creatinine formula [see Appendix 4])
- •No prior treatment with chemotherapy, immunotherapy and targeted therapy for H&N cancer, radiotherapy or surgery in the head and neck region.
排除标准
- •Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
- •Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment.
- •History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ non-muscular invasive bladder, cervix, uterine and/or prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum/anus.
- •Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction < 50%.
- •Other active infections (viral and/or bacterial and/or mycotic) requiring systemic treatment at the day before randomization
- •Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support).
- •Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis
结局指标
主要结局
Best objective response rate evaluated by the investigators with head and neck radiological imaging according to RECIST version 1.1 criteria at the end of induction phase of EGFR-ADC MRG003 + anti-PD-1 Pucotenlimab or EGFR-ADC MRG003 alone (21 ± 7 days after the Day 1 of last cycle of induction treatment). Objective response (OR) includes complete and partial response
Best objective response rate evaluated by the investigators with head and neck radiological imaging according to RECIST version 1.1 criteria at the end of induction phase of EGFR-ADC MRG003 + anti-PD-1 Pucotenlimab or EGFR-ADC MRG003 alone (21 ± 7 days after the Day 1 of last cycle of induction treatment). Objective response (OR) includes complete and partial response
次要结局
- • Overall survival (OS) defined as the time between randomization and death from any cause or date of the last follow-up for patients alive.
- • Progression-free survival (PFS) as the time from randomization to the first progression (locoregional/metastatic progression after induction, CRT or adjuvant treatment) or death from any cause, or the date of the last follow-up for patients who did not have progression or death.
- • Failure-free survival (FFS) as the time from randomization to the first of the following events: locoregional /metastatic progression after the completion of CRT or failure to receive CRT; or death from any cause or the date of the last follow-up for patients who did not have these events.
- • Compliance: for radiotherapy, total tumor dose, total number of fractions, total duration and major deviations will be reported and for anti-PD-1 + EGFR-ADC and cisplatin, number of cycles/injection, total dose, total duration of the treatment and dose intensity, and relative dose intensity (i.e. ratio of the dose received by the planned total dose). Whatever the treatment, treatment interruption, reduction and discontinuation and their reasons will be reported.
- • 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 from the randomization to one month after the end of the adjuvant treatment
研究者
Dr Yungan TAO
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (18)
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