NCT07387198招募中2 期
Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab - A Randomized, Double-blind, Placebo-controlled, Non-comparative Phase II Study
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest14 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2026年5月29日最近更新:
干预措施
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
- 14
- 主要终点
- Nodal micrometastases-free rate
研究概览
简要总结
The study is a randomized, double blind, placebo-controlled, non-comparative phase II trial that investigates the efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment in patients with clinical stage I or II Merkel cell carcinoma who have have undergone primary tumour excision and are pending sentinel lymph node biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 primary tumor already removed and a planned sentinel lymph nodes biopsy still pending.
- •Patient has ECOG performance status 0-
- •Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
- •Absolute number of neutrophils ≥ 1.5 x 109/L
- •Platelets ≥ 75 x 109/L
- •Hemoglobin ≥ 9 g/dL
- •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)
- •AST (SGOT) and ALT (SGPT) ≤ 3x ULN
- •AP ≤ 2.5x ULN
- •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 (PT, sentinel lymph node biopsy).
排除标准
- •Patient has prior sentinel lymph node removal for the current MCC.
- •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.
- •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 p 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 β-HCG 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
研究组 & 干预措施
Arm A (Cemiplimab)
Experimental
2 cycles of Cemiplimab (350 mg, i.v., Q3W) followed by sentinel lymph node biopsy
干预措施: Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles (Drug)
Arm B (placebo)
Placebo Comparator
2 cycles of placebo followed by sentinel lymph node biopsy
干预措施: Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles. (Drug)
结局指标
主要结局
Nodal micrometastases-free rate
时间窗: up to 36 months
rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy
次要结局
- Recurrence-free survival(up to 66 months)
- Overall survival(up to 66 months)
- Disease specific survival(up to 66 months)
- Quality of life using FCRI-SF questionnaire(up to 66 months)
- Safety (AEs and SAEs)(up to 66 months)
- Quality of life using the mFACT-M questionnaire(up to 66 months)
研究者
研究点 (14)
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