Anyone with Kras G12V or G12D, NIH trial needs you

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DH2Sleen
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Joined: Thu Jan 29, 2015 10:10 am

Anyone with Kras G12V or G12D, NIH trial needs you

Postby DH2Sleen » Wed Aug 22, 2018 7:07 am

So, Sleen and I were at NIH yesterday for follow-up. She is cancer free. That's right, cancer free. Three years after TIL treatment and no cancer.

But in our conversation with Dr. Yang, we found out that they are having virtually no applications for the engineered T-cell receptor trial for Kras G12V (trial #NCT03190941, https://clinicaltrials.gov/ct2/show/NCT03190941). He finds it quite astounding that, considering nearly 1/2 of all cancer is Kras, and 1/7 of the US population should match the HLA requirement, almost no applicants have matched in a year of seeking patients. He says that there are probably over 20,000 people who could be eligible. So he (unofficially) asked us to help spread the word (NIH can't officially solicit patients).

If you are Kras G12V (already recruiting) or G12D (unofficially looking for patients) call NIH to ask about the trial (866) 820-4505. They will send you a kit to test your HLA. You have no obligation or cost. But if you qualify, this could be a cure (my assessment, not theirs). The trial process is not easy, and it takes a month, so "healthy" Stage IV patients are the best candidates. It is basically the same process Sleen went through but without tumor harvest surgery. I think that this process is the best chance for a stage IV Kras patient to survive long-term.

And just to make sure you understand what could be the result, Sleen is back to her normal lifestyle, with no treatment whatsoever. We are so grateful for the opportunity she had to participate in this research, and we would hate for this Kras trial to be cancelled due to lack of participation. I think it has more potential to help with Kras cancer than any approved treatment.

I would be glad to discuss this trial with anyone thinking about it; either publicly or privately. Let's help get this groundbreaking research moving.
DW, Sleen dx 9/2013 @47yo: IIIc T4b N2b MX
09/2013 colectomy
10/2013 - 3/2014 FOLFOX
04/2014 - 6/2014 Rad to bladder
12/2014 +'ve for lung mets, MX becomes M1
03/2015 enter TIL trial @ NIH
07/01/15 Receive 148E9 cells to target K-ras G12D mutation
08/11/15 Reduction=18%, no new tumors
09/15/15 25%
10/20/15 27%; PET -> one hot met
11/24/15 30% all mets shrinking
01/26/16 46% but one suspicious met
03/24/16 46% but one growing
04/07/16 Lung lobectomy NED for the first time

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Jack&KatiesMommy
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Joined: Wed Dec 21, 2011 1:08 pm
Location: Columbus, OH

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby Jack&KatiesMommy » Wed Aug 22, 2018 9:46 am

Hello:
Thank you for sharing! Can you explain what you mean about no surgery required? I applied for this trial over a year ago and was told that I needed a solid tumor to harvest in order to participate. (At that time I only had malignant lymph nodes.) Is having a 1cm tumor that is easy to harvest still a requirement for participation?

Cynthia
Cynthia
Mommy to Jack (8) now (16) and Katie (4) now (12)
(My Most Precious Things)
Dx 8/11 Stage IV CRC (liver mets) CEA 2,600+
9/11 Folfiri 2/12: Failed Liver Resection
5/12 HAI pump/removed primary
4/13 Liver Resection
8/13-12/15 (10) RFAs lungs
5/17: Upper Left Lobe of lung resected.
02/18: 3 new lymph mets lung:
05/18: Keytruda (MSS w/Intermediate TMB): CEA: 66.4, 39.2, 23.8, 13, 3.5 1.8, 1.0, 2.8 3.9, 5.0, 5.6, 1.5, .8, .8, 1.1, 1.1
Clear CTs
CEA up to 4.5 Single Node lighting up (mildly)

NHMike
Posts: 2324
Joined: Fri Jul 21, 2017 3:43 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby NHMike » Wed Aug 22, 2018 10:30 am

I wish I had known about this last year as I was G12D.

Genomic tumor testing isn’t standard of care so most don’t know their mutation.
6/17: ER rectal bleeding; Colonoscopy
7/17: 3B rectal. T3N1bM0. 5.2 4.5 4.3 cm. Lymphs: 6 x 4 mm, 8 x 6, 5 x 5
7/17-9/17: Xeloda radiation
7/5: CEA 2.7; 8/16: 1.9; 11/30: 0.6; 12/20 1.4; 1/10 1.8; 1/31 2.2; 2/28 2.6; 4/10 2.8; 5/1 2.8; 5/29 3.2; 7/13 4.5; 8/9 2.8, 2/12 1.2
MSS, KRAS G12D
10/17: 2.7 2.2 1.6 cm (-90%). Lymphs: 3 x 3 mm (-62.5%), 4 x 3 (-75%), 5 x 3 (-40%). 5.1 CM from AV
10/17: LAR, Temp Ileostomy, Path Complete Response
CapeOx (8) 12/17-6/18
7/18: Reversal, Port Removal
2/19: Clean CT

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DH2Sleen
Posts: 80
Joined: Thu Jan 29, 2015 10:10 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby DH2Sleen » Wed Aug 22, 2018 10:59 am

Jack&KatiesMommy wrote:Hello:
Thank you for sharing! Can you explain what you mean about no surgery required? I applied for this trial over a year ago and was told that I needed a solid tumor to harvest in order to participate. (At that time I only had malignant lymph nodes.) Is having a 1cm tumor that is easy to harvest still a requirement for participation?

Cynthia

You are right that the normal TIL trial requires a tumor harvest. But if someone is Kras G12V with HLA:11.01, then they already have a treatment which only requires the apheresis (about 4 hour process) and the chemo-prep, cell infusion, and recovery. Since they already know the mutation and compatibility, they do not require a tumor harvest.
DW, Sleen dx 9/2013 @47yo: IIIc T4b N2b MX
09/2013 colectomy
10/2013 - 3/2014 FOLFOX
04/2014 - 6/2014 Rad to bladder
12/2014 +'ve for lung mets, MX becomes M1
03/2015 enter TIL trial @ NIH
07/01/15 Receive 148E9 cells to target K-ras G12D mutation
08/11/15 Reduction=18%, no new tumors
09/15/15 25%
10/20/15 27%; PET -> one hot met
11/24/15 30% all mets shrinking
01/26/16 46% but one suspicious met
03/24/16 46% but one growing
04/07/16 Lung lobectomy NED for the first time

Brearmstrong
Posts: 87
Joined: Sun Mar 26, 2017 3:24 pm
Location: CT

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby Brearmstrong » Wed Aug 22, 2018 12:05 pm

This sounds wonderful. I'm currently stage IV NED (well just had a CT scan this morning so we shall see) and I'm G12D. I will give them a call. Thank you for letting us know!
45 F Jan 17 2 sons
tumor appendix/colon
Muc Adeno 4cm
mod diff G2 T4aN2
nodes 8/50
CEA 4.6 after surgery <.05
KRAS G12D MSS
FOLFOX Apr-sep 17
Clean CT Jul 2017 lung 4mm, clean CT oct 17, CEA 3.4, nov 17 8.1. May 18 2.3,1.0,1.3, 1.3, 1.0, 2.3, 2.2, 2.1,2.2,1.6
Oct 2017 clean CT
Nov 17 PET para aortic nodes Stage IV
Folfori w/avastin Dec 17 CEA 7.1
May 18- surgery to remove nodes- 5 positive xeloda continues
Aug 18-CT NED Clear CT's Nov 18, Feb 19, May 19, Aug 19,Nov19

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Jack&KatiesMommy
Posts: 597
Joined: Wed Dec 21, 2011 1:08 pm
Location: Columbus, OH

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby Jack&KatiesMommy » Wed Aug 22, 2018 12:26 pm

DH2Sleen wrote:
Jack&KatiesMommy wrote:Hello:
Thank you for sharing! Can you explain what you mean about no surgery required? I applied for this trial over a year ago and was told that I needed a solid tumor to harvest in order to participate. (At that time I only had malignant lymph nodes.) Is having a 1cm tumor that is easy to harvest still a requirement for participation?

Cynthia

You are right that the normal TIL trial requires a tumor harvest. But if someone is Kras G12V with HLA:11.01, then they already have a treatment which only requires the apheresis (about 4 hour process) and the chemo-prep, cell infusion, and recovery. Since they already know the mutation and compatibility, they do not require a tumor harvest.


AHHH! Well, I am G12A...so I would still need a tumor that could be harvested..a.t least at this point. I'll keep watching for updates in case I need it in the future...and hopefully this treatment can help others out there with the G12V or G12D mutation!
Cynthia
Mommy to Jack (8) now (16) and Katie (4) now (12)
(My Most Precious Things)
Dx 8/11 Stage IV CRC (liver mets) CEA 2,600+
9/11 Folfiri 2/12: Failed Liver Resection
5/12 HAI pump/removed primary
4/13 Liver Resection
8/13-12/15 (10) RFAs lungs
5/17: Upper Left Lobe of lung resected.
02/18: 3 new lymph mets lung:
05/18: Keytruda (MSS w/Intermediate TMB): CEA: 66.4, 39.2, 23.8, 13, 3.5 1.8, 1.0, 2.8 3.9, 5.0, 5.6, 1.5, .8, .8, 1.1, 1.1
Clear CTs
CEA up to 4.5 Single Node lighting up (mildly)

sdino
Posts: 72
Joined: Tue Mar 28, 2017 5:32 pm

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby sdino » Wed Aug 22, 2018 1:11 pm

Hi JacknKatieMom - I would still reach out to NCI/NIH and get the ball rolling with inquires and get your name in front of them.
Caregiver for Wife 54 yrs old
DX:11/16-CC sigmoid colon
Lung Mets: Bilateral ranging 4mm-2.3CM
MSS, KRAS-G12D; TP53
Xeloda+Avastin 11/16 to 1/8/17
CT Scans: 5/17 colon & lung met shrinkage,11/17 to 7/19 slight progression
iTCR TIL Trial NCT03412877 4/19 to 5/19 Off trial, - Sept. 2019 doing Original TIL trial NCT01174121
CEA:16-11/16; 0.6-5/17; 5.1-9/18; 5.4-10/18; 26.9-7/19

boxhill
Posts: 392
Joined: Fri Apr 06, 2018 11:40 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby boxhill » Wed Aug 22, 2018 1:16 pm

I'm G12D, but currently have no detectable masses.

It seems that they want people with solid tumors so that they can evaluate the effectiveness. Or am I reading it wrong?
F, 64 at DX CRC Stage IV
3/17/18 blockage, r hemi
11 of 25 nodes,5 mesentery nodes
5mm liver met out
pT3 pN2b pM1
BRAF wild, KRAS G12D
dMMR, MSI-H
5/4/18 FOLFOX
Neulasta 6/28
7/9/18 CT NED
11/20/18 CT NED. Enlarged spleen.
12/20/18 Liver MRI 5mm liver met? and 2 lymph nodes in porta hepatis
12/31/18 Keytruda
6/5/19 Triphasic CT LN and spleen normal, Liver node stable
6/28/19 Pause Keytruda, predisone for joint pain
7/31/19 Restart Keytruda
9/10/19 CT stable

mhf1986
Posts: 158
Joined: Sat Mar 11, 2017 8:30 pm
Location: near DC

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby mhf1986 » Wed Aug 22, 2018 8:18 pm

How does one get tested for the particular mutations? I've read on this board about the Foundation One testing for the Keytruda trials...is that the same thing?

DH did have some testing done but I don't know if it went this far in detail. Our original oncologist didn't seem hopeful about anything so we left him and went to Hopkins.

We are about 15 miles north of NIH...I drive by there most every day to get to my office.

Thanks, M
Caregiver to DH, dx @ 50, mets to liver/lungs, MSS, wild
9/16 CEA 114, blockage, left hemi, perm. colostomy
11/16 port in, FOLFOX + Avastin
6/17 CEA 15, 5FU + A only due to neuropathy
11/17 CEA 38, CAPOX + A
1/18 CAPOX = hi bilirubin/bad hfs, back to FOLFOX + A
5/18 growth; Vectibex + 75% Irinotecan
7/18 CEA 23, shrinkage
10/18 CEA 28, growth of 2 liver tumors/shrinkage of few and lung nodes
11/18 Lonsurf, looking at spheres, proton, trials
11/19/18 Peace

NHMike
Posts: 2324
Joined: Fri Jul 21, 2017 3:43 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby NHMike » Wed Aug 22, 2018 9:13 pm

mhf1986 wrote:How does one get tested for the particular mutations? I've read on this board about the Foundation One testing for the Keytruda trials...is that the same thing?

DH did have some testing done but I don't know if it went this far in detail. Our original oncologist didn't seem hopeful about anything so we left him and went to Hopkins.

We are about 15 miles north of NIH...I drive by there most every day to get to my office.

Thanks, M


I'd guess that any top hospital does them or can send it out. Mass General did mine informally. I don't know whether or not they just do it for their own patients or if they have a service to do it generally.

One of my coworkers with cancer went to Dana Farber and they did it for him and found a drug that controls his mutation.

I asked my local oncologist and he kind of ignored me. In the vast amount of cases right now, knowing it isn't going to help. The thing is what if you are one of the cases where it helps - or at least informs the oncologist that you have a very aggressive mutation?
6/17: ER rectal bleeding; Colonoscopy
7/17: 3B rectal. T3N1bM0. 5.2 4.5 4.3 cm. Lymphs: 6 x 4 mm, 8 x 6, 5 x 5
7/17-9/17: Xeloda radiation
7/5: CEA 2.7; 8/16: 1.9; 11/30: 0.6; 12/20 1.4; 1/10 1.8; 1/31 2.2; 2/28 2.6; 4/10 2.8; 5/1 2.8; 5/29 3.2; 7/13 4.5; 8/9 2.8, 2/12 1.2
MSS, KRAS G12D
10/17: 2.7 2.2 1.6 cm (-90%). Lymphs: 3 x 3 mm (-62.5%), 4 x 3 (-75%), 5 x 3 (-40%). 5.1 CM from AV
10/17: LAR, Temp Ileostomy, Path Complete Response
CapeOx (8) 12/17-6/18
7/18: Reversal, Port Removal
2/19: Clean CT

DebZ
Posts: 83
Joined: Fri Nov 14, 2014 9:01 pm
Facebook Username: Bulc

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby DebZ » Wed Aug 22, 2018 9:19 pm

I was getting pre-screened for the trial, but my low platelets exclude me. Hoping to get them up and try again.
48 @ diagnosis Sept 2014
MSS; Kras mutant G12D
Oct 2014: right hemicolectomy
Dec 2014-May 2015: Folfox
June 2015: clean scans
Sept 2015: scans reveal ovarian mass and liver met; Folfiri
Jan 2016: liver wedge resection and hysterectomy
April 2016: multiple lung mets; Folfiri+Avastin
June 2017: lung mets growing; switch to Folfox+Avastin
Jan-April 2018: dropped oxali; CEA rising
May 2018: back on Folfox+Avastin, add pulse steroid treatment to get platelet count up (continuously in 50s)

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DH2Sleen
Posts: 80
Joined: Thu Jan 29, 2015 10:10 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby DH2Sleen » Thu Aug 23, 2018 6:19 am

boxhill wrote:I'm G12D, but currently have no detectable masses.

It seems that they want people with solid tumors so that they can evaluate the effectiveness. Or am I reading it wrong?

I think you are right about that. The use RECIST criteria to evaluate effectiveness, so they need four to six tumors to remain after treatment to watch them for response. But they may have other trials for people who are NED. It never hurts to call.
DW, Sleen dx 9/2013 @47yo: IIIc T4b N2b MX
09/2013 colectomy
10/2013 - 3/2014 FOLFOX
04/2014 - 6/2014 Rad to bladder
12/2014 +'ve for lung mets, MX becomes M1
03/2015 enter TIL trial @ NIH
07/01/15 Receive 148E9 cells to target K-ras G12D mutation
08/11/15 Reduction=18%, no new tumors
09/15/15 25%
10/20/15 27%; PET -> one hot met
11/24/15 30% all mets shrinking
01/26/16 46% but one suspicious met
03/24/16 46% but one growing
04/07/16 Lung lobectomy NED for the first time

NHMike
Posts: 2324
Joined: Fri Jul 21, 2017 3:43 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby NHMike » Thu Aug 23, 2018 8:51 am

DH2Sleen wrote:I think you are right about that. The use RECIST criteria to evaluate effectiveness, so they need four to six tumors to remain after treatment to watch them for response. But they may have other trials for people who are NED. It never hurts to call.


What would be the purpose for people who are NED? Is this to harvest cells that might be usable for treating other people?

Do they have a way to get your Alleles? Also, do they take C*8:02 along with A*11:01?
6/17: ER rectal bleeding; Colonoscopy
7/17: 3B rectal. T3N1bM0. 5.2 4.5 4.3 cm. Lymphs: 6 x 4 mm, 8 x 6, 5 x 5
7/17-9/17: Xeloda radiation
7/5: CEA 2.7; 8/16: 1.9; 11/30: 0.6; 12/20 1.4; 1/10 1.8; 1/31 2.2; 2/28 2.6; 4/10 2.8; 5/1 2.8; 5/29 3.2; 7/13 4.5; 8/9 2.8, 2/12 1.2
MSS, KRAS G12D
10/17: 2.7 2.2 1.6 cm (-90%). Lymphs: 3 x 3 mm (-62.5%), 4 x 3 (-75%), 5 x 3 (-40%). 5.1 CM from AV
10/17: LAR, Temp Ileostomy, Path Complete Response
CapeOx (8) 12/17-6/18
7/18: Reversal, Port Removal
2/19: Clean CT

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DH2Sleen
Posts: 80
Joined: Thu Jan 29, 2015 10:10 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby DH2Sleen » Thu Aug 23, 2018 9:29 am

NHMike wrote:What would be the purpose for people who are NED? Is this to harvest cells that might be usable for treating other people?

Do they have a way to get your Alleles? Also, do they take C*8:02 along with A*11:01?

So many questions...

I don't know all of the NIH trials, but I think they have some trials in which they are looking at preventing recurrence, so those would be for NED patients.

The only allele they admit to having ready is A*11:01. But as you note, they could easily put together an engineered TCR for sleen's mutation-HLA combination. They just are not publicizing it.

My point is answering Boxhill's question is that everyone should consider working with NIH and let the experts slot them into the trial that is right for their condition.
DW, Sleen dx 9/2013 @47yo: IIIc T4b N2b MX
09/2013 colectomy
10/2013 - 3/2014 FOLFOX
04/2014 - 6/2014 Rad to bladder
12/2014 +'ve for lung mets, MX becomes M1
03/2015 enter TIL trial @ NIH
07/01/15 Receive 148E9 cells to target K-ras G12D mutation
08/11/15 Reduction=18%, no new tumors
09/15/15 25%
10/20/15 27%; PET -> one hot met
11/24/15 30% all mets shrinking
01/26/16 46% but one suspicious met
03/24/16 46% but one growing
04/07/16 Lung lobectomy NED for the first time

NHMike
Posts: 2324
Joined: Fri Jul 21, 2017 3:43 am

Re: Anyone with Kras G12V or G12D, NIH trial needs you

Postby NHMike » Thu Aug 23, 2018 9:41 am

DH2Sleen wrote:
NHMike wrote:What would be the purpose for people who are NED? Is this to harvest cells that might be usable for treating other people?

Do they have a way to get your Alleles? Also, do they take C*8:02 along with A*11:01?

So many questions...

I don't know all of the NIH trials, but I think they have some trials in which they are looking at preventing recurrence, so those would be for NED patients.

The only allele they admit to having ready is A*11:01. But as you note, they could easily put together an engineered TCR for sleen's mutation-HLA combination. They just are not publicizing it.

My point is answering Boxhill's question is that everyone should consider working with NIH and let the experts slot them into the trial that is right for their condition.


I will think about it after I survive reversal. I'm not in any kind of shape for traveling these days.

The reason I ask about C*08:02 is that the odds for A*11:01 are not that good in general but C*08:02 is around 30% for Asians.
6/17: ER rectal bleeding; Colonoscopy
7/17: 3B rectal. T3N1bM0. 5.2 4.5 4.3 cm. Lymphs: 6 x 4 mm, 8 x 6, 5 x 5
7/17-9/17: Xeloda radiation
7/5: CEA 2.7; 8/16: 1.9; 11/30: 0.6; 12/20 1.4; 1/10 1.8; 1/31 2.2; 2/28 2.6; 4/10 2.8; 5/1 2.8; 5/29 3.2; 7/13 4.5; 8/9 2.8, 2/12 1.2
MSS, KRAS G12D
10/17: 2.7 2.2 1.6 cm (-90%). Lymphs: 3 x 3 mm (-62.5%), 4 x 3 (-75%), 5 x 3 (-40%). 5.1 CM from AV
10/17: LAR, Temp Ileostomy, Path Complete Response
CapeOx (8) 12/17-6/18
7/18: Reversal, Port Removal
2/19: Clean CT


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