Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
- Conditions
- Triple Negative Breast CancerRenal Cell CancerSquamous Cell Carcinoma of the Head and NeckHigh Grade Ovarian Serous Adenocarcinoma
- Interventions
- Biological: Modi-1 ModitopeDevice: MicronJet600™ microneedle device (NanoPass)
- Registration Number
- NCT05329532
- Lead Sponsor
- Scancell Ltd
- Brief Summary
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.
- Detailed Description
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.
Modi-1 Moditope will be administered intradermally using the MicronJet600™ microneedle device referred to as NanoPass.
The study aims to enrol 168 (138 in non-neoadjuvant cohorts and 30 in the exploratory neoadjuvant SCCHN cohort) individuals across multiple UK collaborating clinical centres.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 168
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC Modi-1 Moditope Modi-1 Moditope Monotherapy Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort) Modi-1 Moditope Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC MicronJet600™ microneedle device (NanoPass) Modi-1 Moditope Monotherapy Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors Modi-1 Moditope Modi-1 Moditope + Standard of Care Checkpoint Inhibitors Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort) MicronJet600™ microneedle device (NanoPass) Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors MicronJet600™ microneedle device (NanoPass) Modi-1 Moditope + Standard of Care Checkpoint Inhibitors Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort) Pembrolizumab Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab
- Primary Outcome Measures
Name Time Method Incidence of clinical and laboratory adverse events (AEs) 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 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.
- Secondary Outcome Measures
Name Time Method 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) To measure imaging response of Modi-1 Moditope in non-neoadjuvant cohorts, as monotherapy in patients with TNBC, advanced/unresectable HPV-negative SCCHN, HGSOC, or RCC and in combination with CPI therapy (e.g., pembrolizumab, nivolumab, Ipilimumab)
Overall survival For the duration of the study (12 weeks after the final dose of study treatment) The overall survival will measured in patients vaccinated with Modi-1 Moditope either as monotherapy or in combination with checkpoint inhibitors in the target population.
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) The progression-free survival will measured in patients vaccinated with Modi-1 Moditope either as monotherapy or in combination with checkpoint inhibitors in the target population.
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) Pathological response will be measured in tumour tissue of patients vaccinated with Modi-1 Moditope monotherapy or Modi-1 Moditope + Pembrolizumab in patients with SCCHN undergoing planned resection
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) Immune cells will be profiled and measured in tumour tissue of patients vaccinated with Modi-1 Moditope monotherapy or Modi-1 Moditope + Pembrolizumab in patients with SCCHN undergoing planned resection
Trial Locations
- Locations (16)
Royal Surrey NHS Foundation
🇬🇧Guildford, Default, United Kingdom
Mount Vernon
🇬🇧London, Default, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals
🇬🇧Cambridge, United Kingdom
Torbay and South Devon NHS Foundation Trust
🇬🇧Torquay, United Kingdom
Brighton and Sussex University Hospital
🇬🇧Brighton, Default, United Kingdom
Velindre Cancer Centre
🇬🇧Cardiff, Default, United Kingdom
Edinburgh Cancer Centre (NHS Lothian)
🇬🇧Edinburgh, Default, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, Default, United Kingdom
University College London Hospital NHS Foundation Trust
🇬🇧London, Default, United Kingdom
Scroll for more (6 remaining)Royal Surrey NHS Foundation🇬🇧Guildford, Default, United KingdomJoe ThorntonContactinfo@scancell.co.uk