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Contact Information:

Robert Miller +441865582690
info@scancell.co.uk


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Be Part of Research - Trial Details - Modi-1 in Breast, Head and Neck, Ovarian, or Renal Cancer
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Modi-1 in Breast, Head and Neck, Ovarian, or Renal Cancer

Recruiting

Open to: ALL

Age: 18.0 - N/A

Brighton Bristol Cardiff Edinburgh London London London Manchester Newcastle Nottingham Preston Sheffield Sutton Liverpool

Medical Conditions

Triple Negative Breast Neoplasms
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Kidney Neoplasms
Cystadenocarcinoma, Serous

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2022 Apr 2026

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Modi-1/Modi-1v administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass).

Intervention Arm Group : Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; combination);Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; monotherapy);Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC;

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks.

Intervention Arm Group : Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; combination);

Intervention Type : DEVICE
Intervention Description : Intradermal injection device

Intervention Arm Group : Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; combination);Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; monotherapy);Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Brighton and Sussex University Hospital
    Brighton
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  • University Hospitals Bristol and Weston NHS Foundation Trust
    Bristol
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  • Velindre Cancer Centre
    Cardiff
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  • Edinburgh Cancer Centre (NHS Lothian)
    Edinburgh
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  • Guy's and St Thomas' NHS Foundation Trust
    London
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  • Imperial College Healthcare NHS Trust
    London
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  • University College London Hospital NHS Foundation Trust
    London
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  • Christie NHS Foundation Trust
    Manchester
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  • Newcastle Hospitals NHS Foundation Trust
    Newcastle
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  • Nottingham University Hospitals Cancer Centre
    Nottingham
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  • Lancashire Teaching Hospitals NHS Foundation Trust
    Preston
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  • Sheffield Teaching Hospital NHS Foundation Trust
    Sheffield
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  • The Royal Marsden NHS Foundation Trust
    Sutton
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  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Liverpool
    CH63 4JY

Robert Miller +441865582690
info@scancell.co.uk



The study is sponsored by Scancell Ltd



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Read full details for Trial ID: NCT05329532
Last updated 18 November 2022

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