NCT05309421进行中（未招募）2 期
An Open Label, Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Checkpoint Inhibitor Treatment naïve Adults With Unresectable or Metastatic Melanoma
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Change in the best overall response (BOR)
研究概览
简要总结
The purpose of this single arm, multi-national clinical trial in patients with metastatic or unresectable melanoma is to evaluate the BOR and compare it to historical data on patients on anti-PD1 treatment with pembrolizumab alone.
详细描述
Patients will initiate treatment with pembrolizumab at the start of the trial and receive up to 18 treatment cycles (approximately 2 years). Immunization with the EVX-01 will be initiated at Week 12. In total, 10 doses of EVX-01 will be administered intramuscularly, with 6 doses given two weeks apart and 4 booster doses at later time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Be at least 18 years of age on day of signing informed consent.
- •Histologically confirmed, and not amenable to local therapy, metastatic or unresectable melanoma Stage III or Stage IV, as per AJCC 8th ed. staging system.
- •Patient may not have a diagnosis of uveal or ocular melanoma.
- •Patients must be treatment naïve to checkpoint inhibitor (CPI) therapy
- •Patients must have testing for a BRAF mutation prior to study entry.
- •Note: Patients with BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy as first-line systemic therapy and be eligible for this study as second line treatment. At the discretion of the investigator, patients with BRAF V600E mutant melanoma who have NOT received a BRAF inhibitor are also eligible for this study as first line treatment if they meet the following additional criteria:
- •i. LDH < local ULN, ii. No clinically significant tumor related symptoms in the judgment of the investigator, and iii. Absence of rapidly progressing metastatic melanoma in the judgment of the investigator
- •Have measurable disease per RECIST 1.1 as assessed by the local site investigator within 4 weeks prior to the first visit. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Patients must be willing and able to provide fresh or frozen tumor tissue from an unresectable or metastatic site of disease for neoepitope and biomarker analyses. If a sufficient amount of tumor tissue from an unresectable or metastatic site is not available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue. In addition, participants may provide additional biopsy at the time of discontinuation due to progression.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- •Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
- •Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- •Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.
研究组 & 干预措施
EVX-01 in combination with pembrolizumab
Experimental
EVX-01 is administered im. Pembrolizumab is administered according to label
干预措施: EVX-01 (Drug)
EVX-01 in combination with pembrolizumab
Experimental
EVX-01 is administered im. Pembrolizumab is administered according to label
干预措施: Pembrolizumab 25 MG/ML (Drug)
结局指标
主要结局
Change in the best overall response (BOR)
时间窗: Measurements at Baseline through study completion (up to 102 weeks)
Composite of a BOR of complete response (CR) or PR for patients with SD at the time of first EVX-01 administration and a BOR of CR for patients with PR at the time of first EVX-01 administration, within 2 years of treatment with pembrolizumab, as per RECIST 1.1 criteria
次要结局
- Change in overall response rate(Measurements at Baseline through study completion (up to 102 weeks))
- Change in progression free survival (PFS)(Measurements at Baseline through study completion (up to 102 weeks))
- Change in overall survival (OS)(Measurements at Baseline through study completion (up to 102 weeks))
- Number, type and severity of adverse events (AEs) and serious adverse events (SAEs)(Measurements at Baseline through study completion (up to 102 weeks))
- Immunologic response induced by EVX-01(Measurements at Baseline through study completion (up to 102 weeks))
- Percentage of patients in which EVX-01 is generated, produced, and administered(From tumor biopsy sampling to first dose of EVX-01 (up to 16 weeks))
研究者
研究点 (4)
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相关资讯
Evaxion's Personalized Cancer Vaccine EVX-01 Shows Promise in Phase 2 Melanoma Trial- Evaxion Biotech's EVX-01, combined with pembrolizumab, demonstrated a 69% Overall Response Rate in advanced melanoma patients in a Phase 2 trial.
- The trial showed tumor reduction in 15 out of 16 patients, highlighting the potential of EVX-01 as a melanoma treatment.
- 79% of EVX-01's vaccine targets triggered a targeted immune response, validating Evaxion's AI-Immunology™ platform.
- A positive correlation was observed between the AI platform's predictions and neoantigen immune response (p=0.00013), confirming its predictive capabilities.last yearEvaxion's Personalized Cancer Vaccine EVX-01 Shows Promise in Melanoma Phase 2 Trial- Evaxion Biotech reports a 69% Overall Response Rate (ORR) in its Phase 2 trial of EVX-01 combined with pembrolizumab for advanced melanoma.
- The interim analysis showed that 11 out of 16 patients experienced objective clinical responses, with 15 patients exhibiting tumor reduction.
- The complete one-year dataset will be presented at the ESMO Congress, followed by a webinar featuring key opinion leader Professor Georgina V. Long.
- EVX-01, designed using Evaxion's AI-Immunology™ platform, is tailored to individual patient's tumor profiles, potentially enhancing treatment efficacy.2 years ago