Any thoughts on the mRNA vaccine trials for pancreatic cancer?

Posted by kjc12 @kjc12, Sep 22, 2023

I was wondering if anyone has information or opinions as to the pros and cons of being enrolled in Clinical trials for, hopefully,preventing the reoccurrence of Pancreatic cancer. My husband has just completed his Chemotherapy treatments and trying to navigate the future. Thank you for all your advice.

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Congratulations on the completion of the chemo treatments! I hope he's feeling well.

My husband's oncologist was really encouraging him to participate in this, but then we found out that because he had a splenectomy, he shouldn't do it because it was too dangerous.

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mRNA trial that I read about said no prior treatments. So, criteria is important. I haven’t researched extensively but the one I did read about - I was not a candidate.

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@lvtexas

mRNA trial that I read about said no prior treatments. So, criteria is important. I haven’t researched extensively but the one I did read about - I was not a candidate.

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Thank you for the info, much appreciated. I hope things are moving in a positive direction for you.

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Congratulations….wonderful to hear your husband finished treatments. How many treatments did he have and what follows complement of his treatments.
I am on my first “cycle “ and had 8 chemo treatments (every two weeks) so far and wonder if/when to expect there is a break or pause in time between periods of treatments.
Thank you!

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Thank you so much. My husband was scheduled to have 12 Folfirinox treatments after his Whipple surgery in Feb.,23. The treatments wreaked havoc on his body and extreme weight loss. Because of this he had a month off after treatment #7 in July. He resumed in August with the Oncologist’s decision that they would reduce the chemo concentration by 20% and then stop after Treatment #10 which was last Tuesday. He is scheduled for a new CT Scan and complete bloodwork including CA-19 levels on Oct 2 and we will meet on Oct 3 to review everything and hear what the plan is for moving forward. I will keep you posted with outcome of meeting. This journey is never ending and I wish you only positive things ahead. We are learning to take one step at a time, but it is very hard not to jump ahead. God bless you.

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Here is some further information:
- An mRNA vaccine to treat pancreatic cancer https://www.nih.gov/news-events/nih-research-matters/mrna-vaccine-treat-pancreatic-cancer

After results from a small phase 1 study, a phase 2 clinical trial has now opened to test the effectiveness of using an mRNA vaccine for pancreatic cancer.
- New mRNA Pancreatic Cancer Vaccine Trial Starts Next Phase https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out

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Details here: https://clinicaltrials.gov/study/NCT05968326

The "No prior treatments" part does not mean surgery. This is mainly for people who had PDAC tumors resected with clean margins in the last 6-12 weeks.

From the NCT link:

Inclusion Criteria:

Histologically confirmed diagnosis of PDAC
Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
Macroscopically complete (R0 or R1) resection of PDAC
Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to randomization
CA19-9 level measured within 14 days prior to randomization
Interval of between 6 and 12 weeks since resection of PDAC
Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
Adequate hematologic and end-organ function
Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 90 days after the final dose of autogene cevumeran, for 6 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab.
Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.

Exclusion Criteria:

Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
Pregnancy or breastfeeding
Active or history of autoimmune disease or immune deficiency

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I had been told (in consideration of a different study) that "No prior chemo" would not rule me out because all my Folfirinox was before surgery, which I came out of with clean margins and NED for 3 months. They treated my recurrence as if it were a new disease, but the study never materialized for me anyway.

However, this one does explicitly exclude "neoadjuvant" treatment (before surgery), so pretty narrow in scope. It's a possible win for the "surgery first" advocates.

Lots of subtle nuances in what the directors are looking for in any trial, so it's always good to ask and apply if appropriate. This one looks quite promising.

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Yes I found the criteria very specific but can meet some people’s situations

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@markymarkfl

Details here: https://clinicaltrials.gov/study/NCT05968326

The "No prior treatments" part does not mean surgery. This is mainly for people who had PDAC tumors resected with clean margins in the last 6-12 weeks.

From the NCT link:

Inclusion Criteria:

Histologically confirmed diagnosis of PDAC
Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
Macroscopically complete (R0 or R1) resection of PDAC
Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to randomization
CA19-9 level measured within 14 days prior to randomization
Interval of between 6 and 12 weeks since resection of PDAC
Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
Adequate hematologic and end-organ function
Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 90 days after the final dose of autogene cevumeran, for 6 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab.
Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.

Exclusion Criteria:

Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
Pregnancy or breastfeeding
Active or history of autoimmune disease or immune deficiency

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I had been told (in consideration of a different study) that "No prior chemo" would not rule me out because all my Folfirinox was before surgery, which I came out of with clean margins and NED for 3 months. They treated my recurrence as if it were a new disease, but the study never materialized for me anyway.

However, this one does explicitly exclude "neoadjuvant" treatment (before surgery), so pretty narrow in scope. It's a possible win for the "surgery first" advocates.

Lots of subtle nuances in what the directors are looking for in any trial, so it's always good to ask and apply if appropriate. This one looks quite promising.

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looks like i don't qualify ... they took out my spleen and gallbladder as part of the surgery. like you I was NED for about 3 months, then the beast reappeared in my liver. on the Gem regiment now.

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@markymarkfl

Details here: https://clinicaltrials.gov/study/NCT05968326

The "No prior treatments" part does not mean surgery. This is mainly for people who had PDAC tumors resected with clean margins in the last 6-12 weeks.

From the NCT link:

Inclusion Criteria:

Histologically confirmed diagnosis of PDAC
Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
Macroscopically complete (R0 or R1) resection of PDAC
Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to randomization
CA19-9 level measured within 14 days prior to randomization
Interval of between 6 and 12 weeks since resection of PDAC
Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
Adequate hematologic and end-organ function
Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 90 days after the final dose of autogene cevumeran, for 6 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab.
Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.

Exclusion Criteria:

Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
Pregnancy or breastfeeding
Active or history of autoimmune disease or immune deficiency

---

I had been told (in consideration of a different study) that "No prior chemo" would not rule me out because all my Folfirinox was before surgery, which I came out of with clean margins and NED for 3 months. They treated my recurrence as if it were a new disease, but the study never materialized for me anyway.

However, this one does explicitly exclude "neoadjuvant" treatment (before surgery), so pretty narrow in scope. It's a possible win for the "surgery first" advocates.

Lots of subtle nuances in what the directors are looking for in any trial, so it's always good to ask and apply if appropriate. This one looks quite promising.

Jump to this post

@markmarkfl
Our saga appears similar. We have decided I should have returned to chemo asap after surgery but did not and have recurrence. I have surgery on the 16th and then will return to a chemo regimen for awhile.

Did you do chemo post op prior to knowing of a recurrence?

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