Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT05329532
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.
Study:
NCT05329532
Study Brief:
Protocol Section:
NCT05329532