2025-523633-25-00招募中2 期
A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- To describe the proportion of patients who do not require surgery at one year in the intention-to-treat (ITT) population.
研究概览
简要总结
To evaluate the ability of upfront cemiplimab to spare the need for local therapies (e.g., surgery) in patients with difficult-to-treat locally advanced cutaneous squamous cell carcinoma (LA cSCC).
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
- •Male or female ≥ 18 years of age (or based on the country legal age limit for adults) on day of signing the Informed Consent Form (ICF)
- •Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential.
- •Adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 X 109/L, Hemoglobin ≥9 g/dL, Platelets ≥100 x 109/L, Serum magnesium, sodium, corrected total calcium, phosphate, and potassium within normal ranges (or corrected with supplements or appropriate treatment). If these electrolyte ranges are not within normal range despite corrective treatment, then the Sponsor should be consulted to confirm eligibility. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN (unless due to known Gilbert’s syndrome, who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN); in cases of liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed, unless due to known Gilbert’s syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed. Serum creatinine ≤1.5 x ULN or creatinine clearance ≥60 mL/min calculated according to the Cockroft and Gault formula or Modification of Diet in Renal Disease (MDRD) formula for patients aged >65 years. Serum albumin ≥3 g/dL. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 x ULN unless patient is receiving anticoagulant therapy and in therapeutic range of intended used anticoagulant. Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT)≤1.5 x ULN unless patient is receiving anticoagulant therapy and is in therapeutic range of intended used anticoagulant.
- •Signed and dated IEC-approved Informed Consent.
- •Histologic diagnosis of cutaneous squamous cell carcinoma.
- •AJCC stage (8th edition) II (≥ 3 cm largest diameter) - III - IV (M0)
- •Undergone multidisciplinary evaluation and discussion (attendance of ENT/general/plastic surgeon, radiation oncologist and medical oncologist is mandatory) to confirm the following criteria: deemed difficult to surgically treat due to high chances of micro and macroscopic residual disease (R1 & R2 resection) or disfiguring surgery; deemed difficult to treat with radical radiotherapy due to low chances of complete response (e.g. High GTV) or high risk of severe acute or late adverse events (e.g. chondronecrosis); eligible to cemiplimab monotherapy as per Summary of Product Characteristics (SmPC, annex A) for the treatment of adult patients with locally advanced cutaneous squamous cell carcinoma (LA cSCC) who are not candidates for curative surgery or curative radiotherapy.
- •Patient’s refusal of surgical intervention and definitive radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Have measurable disease based on iPERCIST criteria.
- •Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must have a negative serum pregnancy test at screening and must not be breastfeeding.
排除标准
- •Previous radiotherapy for cutaneous squamous cell carcinoma in the region affected by the current malignancy.
- •Concomitant immunosuppressive treatment other than physiological steroid dose (i.e. prednisone 10 mg daily or equivalent).
- •Autoimmune disease; cases with limited cutaneous psoriasis should be discussed by the multidisciplinary team to evaluate possible exemption.
- •Has a known history of active TB (Bacillus Tuberculosis).
- •Current or concomitant enrollment in another therapeutic clinical trial.
- •Has previously received an organ transplant.
- •Has previously received bone marrow transplantation.
- •Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu Mist®) are live attenuated vaccines, and are not allowed.
- •Metastatic disease (every T, every N, M1 according the AJCC 8th edition).
- •Cardiac, pulmonary, infective, neurological disease or any other medical condition that could interfere with treatment according to the treating physician.
- •Previous diagnosis of other malignant neoplasm in the last 3 years (in situ cervical cancer or completely excised basocellular/squamous cell skin cancer are always admitted).
- •History of active primary immunodeficiency, known HIV, active HBV or HCV infection
- •Psychiatric disorder or known substance abuse; person with limitation of freedom (i.e. jailed person).
研究组 & 干预措施
LIBTAYO 350 mg concentrate for solution for infusion.
Test
干预措施: LIBTAYO 350 mg concentrate for solution for infusion. (Drug)
结局指标
主要结局
To describe the proportion of patients who do not require surgery at one year in the intention-to-treat (ITT) population.
To describe the proportion of patients who do not require surgery at one year in the intention-to-treat (ITT) population.
次要结局
- a) Event free survival (EFS). EFS is defined as time from diagnosis until progression, relapse, unplanned re-treatment after initial immunotherapy, or death as a result of any cause. b) Relapse-free survival (RFS). c) Overall survival (OS).
- a) Objective response rate per iPERCIST criteria. b) Proportion of confirmed pCR via biopsy or surgery.
- 3a) NCI-PRO-CTCAE outcome (a selection of them, specifically built according to most frequent symptoms in cSCC patients) at baseline, at the end of upfront cemiplimab treatment, 3 months after the end of treatment in the whole patient court and evaluation of differences among responder vs non-responder patients and among locally treated vs non locally treated patients.
- 3b) Decision regret scale score at the end of upfront cemiplimab treatment, 1 year after the end of treatment in the whole patient court and evaluation of differences among responder vs non-responder patients and among locally treated vs non locally treated patients.
研究者
Paolo Bossi
Scientific
Fondazione GONO Plus
研究点 (10)
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