2024-519593-39-00尚未招募3 期
SWE-NEO: Swedish NeoAdjuvant Trial Comparing anti-PD-1 Monotherapy to Combined anti-CTLA-4/anti-PD-1 blockade in Resectable Stage III Melanoma
Karolinska University Hospital3 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年5月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Event-free survival (EFS), defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, or death from any cause (treatment-related, melanoma related or any other).
研究概览
简要总结
To study event-free survival (EFS) in patients with resectable stage III melanoma, receiving two different neoadjuvant immune checkpoint inhibitor (ICI) regimens, combined anti-CTLA-4/anti-PD-1 blockade or anti-PD-1 monotherapy.
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
- 是
入选标准
- •Participants must be at least 18 years of age.
- •No prior targeted therapy targeting BRAF and/or MEK.
- •Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •World Health Organization (WHO) Performance Status 0 or
- •Patients must have a. Histologically or cytologically confirmed Stage III melanoma. In the case of in-transit metastases (with or without lymph node metastases)‚ ≤3 resectable in-transit metastases are allowed. b. Patients with cutaneous, acral, or unknown primary melanomas are eligible for enrollment. c. Resectable tumors are defined as having no significant vascular, neural or bony involvement. Only patients where a complete surgical resection with tumor-free margins can safely be achieved are defined as resectable.
- •Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female patients of childbearing potential must be willing to use a highly effective method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Highly effective methods of contraception include one or more of the following: a. male partner who is sterile (vasectomised) prior to the female study subject’s entry into the study and is the sole sexual partner for the female subject; b. hormonal (oral, intravaginal, transdermal, implantable or injectable) c. an intrauterine hormone-releasing system (IUS) d. an intrauterine device (IUD) with a documented failure rate of < 1%.
- •Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. A unique female sexual partner must postmenopausal, permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception.
- •No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.
- •No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1.
排除标准
- •Unresectable melanoma
- •Uveal/ocular or mucosal melanoma
- •Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy (including operation), or interfere with the interpretation of study results
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Women who are pregnant or breastfeeding.
- •Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
结局指标
主要结局
Event-free survival (EFS), defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, or death from any cause (treatment-related, melanoma related or any other).
Event-free survival (EFS), defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, or death from any cause (treatment-related, melanoma related or any other).
次要结局
- Relapse-free survival (RFS), defined as time between date of surgery and date of melanoma recurrence, treatment-related death or melanoma-related death, whichever occurs first.
- Distant metastasis-free survival (DMFS), defined as time between date of randomization and date of first distant metastasis, treatment-related death or melanoma-related death, whichever occurs first.
- Overall survival (OS), defined as time between date of randomization and date of death.
- Major pathological response (MPR) (≤10% viable tumor cells), difference in MPR between combined ICI and monotherapy, central review of all surgical specimens by three expert melanoma pathologists.
- Correlation of pathologic response in each arm to RFS, DMFS, and OS.
- Correlation of radiological and clinical response evaluation to RFS, DMFS, and OS.
- Proportion of patients having surgery according to plan (within 10 weeks from first neoadjuvant course).
- Surgical complication rates according to Clavien-Dindo surgical classification.
- Frequency and duration of all grade and grade 3-5 treatment-related adverse events (AEs) according to CTCAE 5.0.
研究者
Hildur Helgadpttir
Scientific
Karolinska University Hospital
研究点 (3)
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