A Phase 1/2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Scancell Ltd
- 入组人数
- 168
- 试验地点
- 16
- 主要终点
- Incidence of clinical and laboratory adverse events (AEs)
研究概览
简要总结
The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced/unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC).
Modi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.
详细描述
This is an open-label, parallel arm, Phase 1/2 study to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine in patients with advanced TNBC, advanced/unresectable SCCHN, HGSOC, or RCC.
Modi-1 Moditope vaccines, consist of a combination of specific peptides conjugated to a toll-like receptor ligand 1/2 adjuvant, designed to enhance immune responses against peptides commonly expressed or upregulated by cancer cells. Thus, improving immune recognition of these cancers and potentially increasing response rates in patients with advanced solid tumours.
The aim of this study is to investigate preliminary efficacy of Modi-1 Moditope, in an open labelled clinical trial, in participants with TNBC, SCCHN, RCC and HGSOC, powered to demonstrate that Modi-1 Moditope have potent anti-tumour activity.
In this trial, Modi-1 Moditope will be administered, either as monotherapy or in combination with a CPI (as standard of care).
In addition, an exploratory, randomised cohort will be included to assess the impact of Modi-1 Moditope (with or without pembrolizumab) in participants with SCCHN scheduled for resection surgery with curative intent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC
Modi-1 Moditope Monotherapy
干预措施: Modi-1 Moditope (Biological)
Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC
Modi-1 Moditope Monotherapy
干预措施: MicronJet600™ microneedle device (NanoPass) (Device)
Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors
Modi-1 Moditope + Standard of Care Checkpoint Inhibitors
干预措施: Modi-1 Moditope (Biological)
Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors
Modi-1 Moditope + Standard of Care Checkpoint Inhibitors
干预措施: MicronJet600™ microneedle device (NanoPass) (Device)
Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort)
Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab
干预措施: Modi-1 Moditope (Biological)
Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort)
Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab
干预措施: Pembrolizumab (Biological)
Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort)
Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab
干预措施: MicronJet600™ microneedle device (NanoPass) (Device)
结局指标
主要结局
Incidence of clinical and laboratory adverse events (AEs)
时间窗: For the duration of the study (12 weeks after the final dose of study treatment)
To measure the incidence of AEs of Modi-1 Moditope (as monotherapy and in combination with a CPI (e.g., pembrolizumab or nivolumab provided as standard of care) when administered intradermally
Cellular immune response to Modi-1 Moditope on IFNγ ELISpot assay
时间窗: For the duration of the study (12 weeks after the final dose of study treatment)
(i) the mean peptide-specific ELISpot response minus two standard deviations is greater than the mean pre-treatment peptide-specific response plus one standard deviation (of this mean); and (ii) the ELISpot response is more than 50 spots per million peripheral blood mononuclear cells.
次要结局
- Imaging Response using RECIST 1.1 and iRECIST to Modi-1 Moditope in the non-neoadjuvant setting(For the duration of the study (12 weeks after the final dose of study treatment))
- Overall survival(For the duration of the study (12 weeks after the final dose of study treatment))
- Progression-free survival in patients vaccinated with Modi-1 Moditope(For the duration of the study (12 weeks after the final dose of study treatment))
- Pathological response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab(For the duration of the study (6 weeks after resection surgery))
- Celluar immune response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab(For the duration of the study (6 weeks after resection surgery))