This is something I believe strongly in - so I'm cross-posting it across my multiple social media outlets:
Here is a personal opinion CLINICAL TRIALS 101 post from my >20 years of being an oncology drug discovery scientist – intentionally just focused on the “big picture” questions.
When should one start "thinking about" clinical trials?
I believe you should start *monitoring* clinical trials immediately after receiving a currently incurable Stage IV diagnosis (if you want to be especially proactive even sooner). Note there is a difference between monitoring and applying… but once you hear that currently incurable diagnosis, you know in your treatment plan that chemo will only work for so long. How long? Depends on the patient… Could be 8 months, could be 8 years – but the point is that when your chemo options start dwindling (at the latest), you want to already have an idea of what is out there and some trial options in mind. Trials take a while to set up logistically and it is better to not have to be trying to figure them out in a panicked/rushed situation. Also: if there is a scientific breakthrough – you want to know about it in order to consider switching over sooner, rather than later!
When should one consider *applying* for clinical trials?
That is a very patient specific, personal medical decision. In general patients (for logical reason) are applying earlier and earlier than they used to. The reason? Immunotherapies and their “potential” – they changed everything. Back in the days when a clinical trial was looking at a “new chemo” there really wasn’t an incentive or logical reason to doing a clinical trial before all standard of care chemo options were exhausted. Why try an unproven chemo when you could just do a proven chemo instead? NOW… the world is completely different. Now you are not comparing two chemos – now you are comparing a known chemo with an experimental agent with “the chance” of VERY durable long term response. Maybe only a low chance, but a real CHANCE. In fact, you DON’T want to wait too long to apply for a clinical trial because your body will be weaker which logically may decrease the odds of an immunotherapy from working and in fact… trials will not take you if you are too weak or have too advanced disease/poor health. When you hear oncologists talk about waiting until you exhaust all options, they are obviously very old fashioned and have not kept up with recent clinical trials. Clinical trial design actually reflects this – although most trials require you be resistant to at least one form of standard of care chemo (e.g. FOLFOX) it often is only 1-2 lines, nowhere close to all lines chemo needing to be exhausted. We even have a few immunotherapy trials which do not require resistance to any standard of care chemo prior to trial.
Are there immunotherapy trials for MSS-CRC?
When you hear an oncologist say that “immunotherapy doesn’t work for MSS-CRC” or that “there are no trials”. In the first case they are only referring to the fact that there are no FDA approved immunotherapies for MSS-CRC. There have been immunotherapy responses in MSS-CRC. Yes, MSS-CRC is in fact tough to treat with immunotherapies but for the people it has worked in so far, I am guessing that they were probably glad they tried... In terms of no trials being available for MSS-CRC patient enrollment – this is factually false. I have been maintaining a curated list of immunotherapy trials that are open to MSS-CRC patient enrollment for over a year now (it started out as my personal list --- stay tuned for a PENDING ANNOUNCEMENT). Are there immunotherapy trials open to MSS-CRC patients? I have a list of over 50 of them!
Will most clinical trials fail?
Yes. Most fail. But my personal opinion (being currently incurable Stage IV MSS-CRC myself): I would rather do trial(s) and try for that small chance versus simply accepting where standard of care chemo ends. We all know where it ends. In contrast, I think I would rather take a chance on a trial, even if its chances are low, like Sleen did (as you all read about in the NY Times a few weeks ago) or as StephenWinsToday did in our MSI-high CRC population.
You’re free to agree or disagree... but those are my “big picture” thoughts and personal opinions based upon a lot of years in drug discovery research (and being a currently incurable MSS-CRC patient myself).
No matter what path you decide to follow, wishing you all the best, -DK37