The Colon Club

Cynthia,

Thank you for creating this thread, which led me an opportunity to take Keytruda off label.

I visited my Onc.'a office last week. He told me because it would take a week or so to complete the paper work with my insurance company I would have an infusion of Keytruda this Thur.

Also, my onc. told my TMB was 12 instead of 10.24. The hospital did the gene analysis in house instead of sending the tissue sample to Foundation One. I guess the lab made a correction? The tissue sample from my liver biopsy done 4 years ago was used for the analysis.

Further, based on the info from Foundation One and online literature, I believe that my current TMB could actually be around 15 because I have gone through 2 lines of targeted chemos since my liver biopsy.

Hi Cynthia ,
I have been following your story and able to share it with my friend who is having treatment for stage 4 lung cancer . She is responding really well to Keytruda .

I thought you might be interested to know there is a clinical trial now open here for Immuotherapy with MSS patients !! How good is that !
Take care,
Stu

Boswind and all,

Have you figured out if there is any correlation between the number of somatic variants/mutations listed and TMB? I noticed that Cynthia listed the 12 variants and her TMB is 12. I know gremline variants (those from your parents) don’t count toward TMB since the immune system likely doesn’t react to them being abnormal. I’m also aware that there isn’t a single standard of how to measure TMB and each company does it differently.

I had a NGS performed by Tempus. It says my TMB is only 3.4. However, I have 21 somatic variants so I’m wondering if Tempus’s TMB is an apples-to-apples comparison to Foundation One.

Really? ??....a new clinical trial for mss? ?
In which country? ?..this is a great news ...new hope ...I would be really grateful if you could give me more info....
Thank you for sharing! !

Always ...walk on!!

The UK which really is a surprise as we are way behind with accessing it for MSI patients yet here is this clinical trial!! I know someone going on it too who has failed first and second line chemo . Quite exciting !!
Stu

Wow..that's great! !!!!!...I'm Italian but I live in Manchester uk and I'm treated at the Christie hospital but I'm also in touch with Italian doctors. .but no one told me anything about it although I did ask....

Thanks again! !!!

Let me check but I think Christie’s is one of the trial locations !!!

I love this group!!!. .you guys are so amazing. ..always ready to help....
Thanks so much! !!!

Cynthia,
I just wanted to thank you for sharing your post and experiences here. My wife is MSS and has had confirmed recurrence and we are currently waiting on genetic testing results on her most recent biopsy. This forum is a wonderful resource because of participants like yourself. Thank you for sharing hope and current trends. We learn so much from each other here. Thanks again!
WS

If you search clinicaltrials.gov with terms such as "TMB", “tumor mutation burden”, “tumor mutational burden”, “tumor mutation load”, or “tumor mutational load”, you will see quite a few TMB-H clinical trials that are on-going or to start. Unfortunately, there is only one trial in the US that we may be eligible for (but not yet to recruit):
--
A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy
in Participants With Advanced or Metastatic Solid Tumors of TMB-H
Phase 2
NCT03668119
Not yet recruiting in the US
--
I found the countries that have the most TMB-H clinical trials include Italy and China.

You can look into the TAPUR trial for Keytruda. It is sponsored by ASCO and open almost everywhere with new cohorts. Google TAPUR and ASCO. However, be careful with immunotherapies; they can exclude you from a lot of trials if you fail but make you eligible for a few others. However, the scale is heavier towards exclusion. I have 13 TMB and appear to have failed keytruda as a
monotherapy. I have had 3 infusions and my CEA continues to rise and tumors continue to increase 50% month-over-month.

bdoyle wrote:You can look into the TAPUR trial for Keytruda. It is sponsored by ASCO and open almost everywhere with new cohorts. Google TAPUR and ASCO. However, be careful with immunotherapies; they can exclude you from a lot of trials if you fail but make you eligible for a few others. However, the scale is heavier towards exclusion. I have 13 TMB and appear to have failed keytruda as a
monotherapy. I have had 3 infusions and my CEA continues to rise and tumors continue to increase 50% month-over-month.

I’m sorry to hear keytruda hasn’t achieved the desired response. I’m not sure if you are aware, but a minority of patients have a delayed response to immunotherapy:

https://www.onclive.com/publications/on ... -responses

bdoyle wrote:You can look into the TAPUR trial for Keytruda. It is sponsored by ASCO and open almost everywhere with new cohorts. Google TAPUR and ASCO. However, be careful with immunotherapies; they can exclude you from a lot of trials if you fail but make you eligible for a few others. However, the scale is heavier towards exclusion. I have 13 TMB and appear to have failed keytruda as a
monotherapy. I have had 3 infusions and my CEA continues to rise and tumors continue to increase 50% month-over-month.

That’s around 9 weeks? I’ve read it can take 12, are you going to continue through the 12 weeks are look for something else?

Hi ,
Manchester is one of five locations . It’s open to May 2019 . It’s quite a small trial . Phase1 I think but Phaze 2 maybe in the pipeline .

Maybe only allowing people who have not had success with chemo to enter . Not sure though .

Take care ,

Stu

Thanks stu for the info!!
I'll ask to my onc about it. ...

Grazieeee

Always walk on