The ModiFY trial has started! Whoop whoop!
This is a trial of a new vaccine sponsored by Scancell. The official title is “A phase 1/2 open-label study of Modi-1 in patients with breast, head and neck, ovarian or renal cancer”. The objective is to find out if the modi-1 treatment can be used safely. There are two arms, one for people taking modi-1 only, and another with it combined with a checkpoint inhibitor eg nivolumab. The treatment contains three peptides (small parts of a protein) designed to help the immune system destroy the cancer by generating more T-cells.
What I didn’t realise about trials, was that the numbers are limited. This study has c138 participants and when my name was put forward by my oncologist there was only one place remaining and three standby places.
Signing the form was only the beginning. This really is a venture into the unknown. At the next session (screening), a humongous amount of bloods (about 15 vials) was required, ECG, a physical exam, and checks on my co-ordination, knee reflexes, including the heel-to-toe walk in a straight line you see on the TV conducted by the police to establish whether you are under the influence of drugs or alcohol. Needless to say, the outcome was OK.
A couple of weeks later I got an appointment for a CT scan with an iodine oral contrast (gastrografin) sent in the post that I was to drink with ½ pint of orange juice an hour beforehand. New! Googling this suggested it might not taste very nice, but it was nothing and I managed to devour it with zero incident on my train journey in.
Another change was to move my treatment base into the teaching hospital where my oncology unit is. Trial protocol can’t accommodate splitting treatments in different places, and that includes bloods. I now have a treatment schedule up until September. It’s so much busier than before.
Trial week 1 started on Monday 5th June. Pre-screening comprised bloods and more chit chat. Today (Tues) it was the Real Thing, the Modi-1 injection. It actually comprises 4 injections, each containing different peptides and the injection takes some time, about a minute each site. It uses a different needle to a covid vaccine, designed to achieve entry under the skin at 45o. I was anxious it might be like a rhesus negative anti-D injection which is quite “thick” and painful. I need not have worried. It was just a bit uncomfortable. Immediately afterwards there was some throbbing and significant skin reaction at the injection sites. This subsided after about an hour. I was highly entertained by the floppy ruler branded “Scancell” to measure the skin reaction! 
I’ve still got two red blotches 5 hours later. The first two injection sites are hardly visible now to the naked eye. About 30 mins after the injections I felt very fatigued.
Being day 1 there was lots of waiting around. I arrived at 9:30am and the (frozen) drugs didn’t arrive until 11am. I had to wait for an hour afterwards to check for any adverse reactions. I cycled back to the station.
I’m still learning the new protocol and ambience at this day centre. It’s been very quiet so far. But there are USB charging sockets on the chair woo hoo, and I did note only one chair had a surrounding curtain so I’d better keep up my good form during treatment to maintain my privacy. The tea trolley was A1 for the NHS space with hot tomato soup at lunch.
I’m back next week for my nivolumab dose. Also, it is lovely that face masks are now no longer being worn. People have faces again and I can hear what they are saying lol.
