2025-522091-84-00招募中2 期
NeoMatryx - Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 inhibitor Cemiplimab – A randomized, double-blind, placebo-controlled, non-comparative Phase II study
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH13 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2026年1月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 13
- 主要终点
- Nodal micrometastases-free rate defined as the rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy
研究概览
简要总结
The primary objective is to evaluate the immediate efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment prior to sentinel lymph node biopsy in patients with clinical stage I or II Merkel cell carcinoma (MCC).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient has signed informed written consent.
- •Patients is 18 years and older at time of signing of written informed consent.
- •Patient has diagnosis of Merkel cell carcinoma in clinical stage II, or in stage I with minimum diameter of 1 cm, with the primary tumor already removed and a planned sentinel lymph node biopsy still pending.
- •Patient has ECOG performance status 0-
- •Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters. a. Absolute number of neutrophils ≥ 1.5 x 109 /L b. Platelets ≥ 75 x 109 /L c. Hemoglobin ≥ 9 g/dL d. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial’s medical expert) e. AST (SGOT) and ALT (SGPT) ≤ 3x ULN f. AP ≤ 2.5x ULN g. Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
- •Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy.
- •Patient must be willing to allow translational work-up of tissue samples (primary tumor, sentinel lymph node biopsy).
排除标准
- •Patient has prior sentinel lymph node removal for the current MCC.
- •Patient has Active infection requiring systemic therapy, including uncontrolled HIV, HBV and HCV infection or diagnosis of immunodeficiency. NOTE: Patients are eligible if: • Patients have controlled HIV infection with CD4 counts is > 350 cells/µL and viral load is undetectable [HIV RNA PCR]. Patients with controlled HIV infection must be monitored per local standards during the trial. • Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undetectable serum viral load [HBV DNA PCR]. Patients with controlled infection must undergo periodic monitoring of HBV DNA and must remain on anti-viral therapy for at least 6 months after last dose of Cemiplimab • Patients positive for HCV antibody have controlled HCV infection with undetectable viral load [HCV RNA PCR]
- •Patent received vaccination with any live vaccine (e.g., intranasal flu vaccine) within 4 weeks before the first dose of Cemiplimab or planned vaccination with live vaccine during the trial.
- •Female patients, who are pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment.
- •Patient has evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment- related complications or may affect the interpretation of study results.
- •Patient has known substance abuse or other psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
- •Patient is legally incapacitated or has limited legal capacity.
- •Patients received prior treatment with immunotherapy (such as PD-1/PD-L1 or CTL4) or any other systemic anti-tumor (MCC) therapy (incl. investigational therapies)
- •Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or not.
- •Patient had prior organ transplantation including allogenic stem-cell transplantation.
- •Patient receives immunosuppressive concomitant medication, EXCEPT for the following: i. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra- articular injection). ii. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent. iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- •Patient has known hypersensitivity to any component of the Cemiplimab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein.
- •Patient has active autoimmune or inflammatory disorders
- •Patient has history of interstitial lung disease
- •Patient has active infection requiring systemic therapy.
结局指标
主要结局
Nodal micrometastases-free rate defined as the rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy
Nodal micrometastases-free rate defined as the rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy
次要结局
- Recurrence-free survival (RFS) defined as time from randomization until date of to the date of the first of the following events: i. MCC progression or ii. MCC recurrence or iii. MCC-related death (DSS)
- Overall survival (OS), defined as time from randomization until date of death from any cause
- Disease specific survival (DSS), defined as time from randomization until date of MCC-related death
- Quality of life (QoL) using FACT-M questionnaire: (i) FCRI-SF questionnaire (ii) mFACT-M questionnaire
- Descriptive comparison of neoadjuvant Cemiplimab with placebo treatment prior to sentinel lymph node biopsy regarding: nodal micrometastases-free rate, RFS, OS, DSS, QoL
- Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5
- Descriptive comparison of safety between neoadjuvant Cemiplimab and placebo treatment prior to sentinel lymph node biopsy
- Correlation of identified biomarker with clinical outcome, i.e., nodal metastases-free rate, RFS, OS
研究者
Clinical Trial Project Manager
Scientific
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
研究点 (13)
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