Triple Negative Breast Cancer Clinical Trial
Official title:
A Phase 1/2, Multicentre, Open-Label Study of Modi-1 in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer
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 Modi-1 alone.
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. ;
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