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Clinical Trial - Modi-1 in Renal Cancer (The ModiFY study)

Mmum
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Hi Folks

This trial is currently underway and will be opening again for more candidates in some locations in due course.  I've been provided the info as I tick the boxes.  

The purpose of the study is to find out if new treatment Modi-1 can be used safely for breast, H&N, ovarian or renal cancer and benefit these types of cancer.  Modi-1 is designed to help your immune system attack and destroy cancer cells.

Brief Summary: "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)."

Just sharing as a heads-up, to meet others considering it, or on it.  I haven't done the background reading yet but I'm likely to go for it.  

  • Hi  

    I'm not on this trial but I noticed that your post hadn't had any replies yet. I searched the group for previous posts mentioning 'Modi-1' and 'ModiFY' but drew a blank I'm afraid.

    Do keep us up to date with how you get on

    x

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  • in reply to latchbrook

    I will and thank you

  • If you research the whole system not a particular thread you will find some on it under head and neck. One I recall had no options left and so far has seen a 55% reduction in their tumour so far. Rumour says a number have gone from progressive to stable (so far) in other cancers. The company involved is Scancell so they may have updates on the trial for anyone to check. I'll look them up

  • Here it is, I hope that helps

    https://www.scancell.co.uk/Data/Sites/1/media/publications/rns/modify-efficacy-data-final-20.02.23.pdf

    To date, 23 patients have been vaccinated with Modi-1 and all have had skin reactions at the injection sites consistent with a delayed-type hypersensitivity (DTH) reaction indicative of a T cell response. So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study. As no dose limiting toxicities were observed in the monotherapy dose escalation cohorts, patients continue to be enrolled into both the ongoing monotherapy expansion cohorts and the CPI combination dose escalation cohorts during H1 2023.

  • Here is the person that has been posting all about Modi and the one that has seen a 55% reduction so far when nothing else could help her. She signs off as Trish.

    community.macmillan.org.uk/.../activities

  • in reply to wellywalker

    Just back from the introductory meeting with oncology about this.  Consent forms signed and there's a place reserved for me subject to final checks at their end.  Exciting!

  • What is the criteria for box ticking?

  • in reply to Rojan

    The criteria for the trial are:

    1/ Cancer type in the hit list (breast, H&N, RCC, ovary) think it's more granular than that top level list, but you get the idea.

    2a/ Cancer type not eligible for immune checkpoint inhibitor 

    OR

    2b/ Cancer being treated with immune checkpoint inhibitor (PD-1) eg nivolumab AND there is an ongoing response. 

    Link here.

  • in reply to Mmum

    Hello Mumm

    as usual, thank you for sharing this. Is this a one-off vaccine, or is it a course of treatment which will augment Nivo infusions - sorry that it's such a basic question, but I can't quite get my head around it. Thanks, 

    Bodger 23 (my new alias)

  • in reply to Bodger23

    Hiya - it's a 2 year treatment, with the vaccine being given 10 times; on day 1, and then weeks 4, 7, 13, 25 and after that every 12 weeks.  It runs alongside nivolumab or pembro or whatever checkpoint inhibitor is being used.  It's a course, exactly as you describe above. 

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