Help with clinical trials (RMC-6236 and it's variations)
Hi everyone,
My husband who has stage 4 pancreatic cancer is approaching the end of his chemotherapy treatment and i'm trying to explore next step options / trials but the information can be really confusing and overwhelming in terms of inclusion criteria.
He was diagnosed stage 3 and had a whipple. Post whipple he started on Folfrinox and then switched to Irinotecan due to tolerance issues. 2 months later a pet scan revealed mets in his liver so the chemo was considered not effective and switched to Gem/ Abraxane which he responded wonderfully to. His latest scans that all the mets have dissapeared. We have 6 more chemotherapy sessions to go.
Can he get on any versions of the RAS inhibitor trials? Or has he had too many prior lines of chemo? I'd be delighted to hear from those of you that have been on the trials or if anyone can point me in the right direction that would be great.
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Hi, the ongoing clinical trial of the RAS inhibitor RMC-6236 includes a requirement for participants to have been previously treated with one prior line of therapy based on 5-fluorouracil (5-FU) or gemcitabine, as well as a certain time interval after surgery. My husband is currently on cycle 12 of the RMC-6236 trial (almost 8 months) and his tumor remains stable. He is stage IV, has not had surgery, and completed 12 cycles of FOLFIRINOX and SBRT before starting the clinical trial.
Currently, several other trials for KRAS mutations are open, and in my opinion, it’s best to discuss these options directly with your oncologist and also contact the Pancreatic Cancer Action Network, which can assist with recommendations for further trial searches based on your husband’s overall condition, prior treatment history, and tumor mutation profile. Their contact number is (877) 297-1862.
Links to their website and the RMC-6236 trial are below:
https://pancan.org/facing-pancreatic-cancer/patient-services/contact-us/
https://www.clinicaltrials.gov/study/NCT06625320.
I hope this helps a bit as you continue to look for the right options.
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1 ReactionMy wife has had the same treatment as your husband. Can you direct me to any of the RMC-6235 trials that you find that are looking for subjects please.
Hi, I’m Ginger. My husband was just given approx 6 months to live, possibly 9-12 with more Chemo and clinical trial ( if he qualifies) his ONLY Pet Scan was done Nov 1st and showed mets to his liver as well. I believe that anything is possible and refuse to accept that he might not have much longer. I researched some trials and as you stated, they are so confusing as most of what I read is in “med-speak,” as I call it.
I hope and pray your husband continues to do well, you are not alone! You can message me anytime, if you want to talk, or a shoulder to cry on.
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2 Reactions@keepingoptimistic RMC-6236 (typo in your response?)
@gingerjt i was told similar news 11/2021. Stage 4, etc etc
Attitude, hope, and health are most important. Im not cured but i am still here and living my life. Doctors give us the worse case scenarios.
Be your own advocate and always, always get multiple opinions! Lastly, lean onbtge Lord. He us with us always.
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3 ReactionsI meant RMC-6236. Sorry
Thank you so much everyone for all of your answers. I will update as soon as i have any further news on whether there are any trials he can join as i believe there are others that can benefit from this knowledge as well. This is a wonderful community and thank you all so much for being here.
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1 ReactionJust for background info, "RAS" includes at least 3 subtypes (HRAS, NRAS, and KRAS), with KRAS being the most common in PDAC. In trial descriptions, you might see the descriptor "pan-RAS" which means it applies to more than one of these.
Each of those can be refined further; examples for KRAS include G12C, G12D, G12V, G13C, etc. In trial descriptions, you might see the descriptor G12X which means it applies to more than one of these.
You might also see descriptors "RAS(ON)" , "RAS(OFF)", or "RAS-ON" and "RAS-OFF" which describes drugs providing unique mechanisms of action relevant to very specific tumor mutations.
Also, if you're doing a search at clinicaltrials.gov, cancer.gov, or another site, you might not find pancreatic cancer listed as one of the diseases being targeted in a trial. Sometimes that's because the researchers are specifically not targeting PDAC. But in other cases, you may see "solid tumor" as one of the diseases or requirements. PDAC patients usually meet this criteria but often overlook it in their search.
Regarding previous lines of treatment: That is unique to every study. I tried getting into one of the RevMed Phase-1 trials combining RMC-6236 (pan RAS) combined with RMC-9805 (G12D) but didn't qualify because I'd already had too many lines of treatment. Some of the research teams are very specific about the market they're trying to get approval for, and such limitations sometimes ease that burden for them.
I wound up in a Phase-1 trial called MOONRAY of a new KRAS G12D inhibitor oral drug from Eli Lilly. Still too early to tell if it's working for me. Aside from vomiting, indigestion, and fatigue, the side effects are minor and manageable. This is a common trait of drugs with narrower targets than pan-RAS drugs.
Once you find an appropriate trial, there's still a lot of luck required to get accepted for one. One research nurse told me a LOT of it is being in the right place at the right time. I would add that sometimes "who you know" is also a factor. Applying (calling or emailing) blindly has not worked for me. I got both the RevMed consideration and the MOONRAY acceptance based on referrals from one of my many medical oncologists.
But as a general idea of what's out there, Click the link for my 37 search results from
https://clinicaltrials.gov/search
which searched just for the terms "KRAS G12D" and Status = Recruiting.
Sorry for the length, but I hope this is pan-Helpful. 😉
Cheers and good health,
--mm
P.S. The last paragraph in this blurb: https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-presents-updated-data-rmc-6236-monotherapy includes a few more interesting comments and insights about RevMed and their KRAS targeting drugs.
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3 Reactions@keepingoptimistic , I think you're reply was specifically for @ekaptur. In the meantime, here are some RMC-6236 related trials I found on clinical Trials.gov
- Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS https://clinicaltrials.gov/study/NCT05379985
See all https://clinicaltrials.gov/search
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1 ReactionI am so confused and scared. My husbands liver mets ( which had a great initial response and dissapeared on Gem/Abrax combo came back in less than 8 weeks) So it seems like the only way forward is to try clinical trials but the information on the clinicaltrials.gov page seems to be out of date. I called Revolution Medicine today and most of the trials that are listed as recruiting are closed. I don't know how to move forward? Do i just frantically call around every potential listing? Do we just wait until we maybe (?) get into a trial while his liver mets keep growing? This is even harder to navigate from here in Turkey with the time difference. Please let me know of your experiences.