The main objectives of this study are to assess the safety, tolerability, immunological
activity, and preliminary efficacy of the Modi-1/Modi-1v vaccine, both as monotherapy and in
combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab (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 will also be investigated in the neoadjuvant setting for patients with SCCHN
undergoing curative intent surgical resection in combination with pembrolizumab versus the
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/Modi-1v vaccine in patients
with advanced TNBC, advanced/unresectable SCCHN, HGSOC, or RCC.
The study proposes a trial of novel Modi-1/Modi-1v 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 vaccine(s), in an open
labelled clinical trial, in participants with TNBC, SCCHN, RCC and HGSOC, powered to
demonstrate that Modi-1 vaccines have potent anti-tumour activity.
In this trial, Modi-1/Modi-1v 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 (with or without pembrolizumab) in participants with SCCHN scheduled for resection
surgery with curative intent.
Modi-1/Modi-1v will be administered intradermally using the MicronJet600™ microneedle device
referred to as NanoPass.
The study aims to enrol 144 (114 in non-neoadjuvant cohorts and 30 in the exploratory
neoadjuvant SCCHN cohort) individuals across multiple UK collaborating clinical centres.
Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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