Ask For Foundation One Test, and Keytruda?

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meatie
Posts: 408
Joined: Wed Aug 20, 2014 8:13 am
Location: San Jose, CA

Ask For Foundation One Test, and Keytruda?

Postby meatie » Fri Aug 02, 2019 9:24 pm

For those of you that are on Keytruda (pembrolizumab), and met the mutation burden threshold after taking the Foundation One Test, are you technically on a "clincal trial" while being treated with Keytruda?

My mother is currently on Stivarga, which seems to be keeping most of the mets under control. But a new lymph node met popped up on a scan in july, and stivarga does not seem to work for that one node. The staff at our clinic hinted at clinical trials at UCSF, but didn't mention anything about Foundation One Test or Keytruda, as our onc is on vacation. We won't get the see the onc until late August.

I need some suggestions on what I will discuss with our onc at the next appointment. How do I go about mentioning to the onc about the Foundation One Test for mutation burden, if the onc himself does not suggesting trying Keytruda?

Meatie
Mother DX @59 8/14
cln+lvr res 9/14, stage 4
FOLOX+Avs 12-rd 10/14 to 4/15
Reoccurrence, KRAS mutant 11/15
Folfiri 18-rds 11/15-8/16
FOLFIRI with Ramicirumab 28-rds 8/17-9/18
Regorafenib 10/18-10/19
Lonsurf 10/19 onward

Rock_Robster
Posts: 399
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: Ask For Foundation One Test, and Keytruda?

Postby Rock_Robster » Fri Aug 02, 2019 11:47 pm

Hi Meaty,

I’m not on Keytruda, but I simply asked my oncologist whether he could order TMB testing on my retained biopsy, to see whether I might be a candidate for immunotherapy. He said he would be happy to do if but I’d have to pay for it out-of-pocket, as neither public nor private health funds in Australia cover this level of testing yet.

If your mum is already on Stivarga, there are some fascinating new results released at ASCO this year combining this drug with Keytruda to elicit a response in even MSS/low-TMB patients. You may hence also want to ask your onc about the results from the REGONIVO trial. Given both drugs are already approved for CRC you could potentially access them now outside of a trial, although I don’t know about funding for the Keytruda (e.g. it’s not funded for MSS here yet).

Good luck,
Rob
Male 37; Melbourne, Australia
10/2018 Dx 3.5cm RC adenocarcinoma, 12cm from AV
Mod diff, EMVI+ LVI+ PNI-
3 LN; 4 liver mets
pT3pN1aM1a; Stage IVa. MSS, NRAS (G13R)
CEA: Oct-18= 12; Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0
11/18 - FOLFOX x 6
3/19 - Liver resection
4-5/19 - 25 x pelvic radiation; complete met. response
07/19 - ULAR (robot), temp ileo, 1/27 LN
08/19 - Missed liver spot
08-11/19 - FOLFOX x 1, FOLFOXIRI x 1, FOLFIRI x 5
12/19 - Planned liver resection #2 & (01/20) stoma reversal

User avatar
meatie
Posts: 408
Joined: Wed Aug 20, 2014 8:13 am
Location: San Jose, CA

Re: Ask For Foundation One Test, and Keytruda?

Postby meatie » Sat Aug 03, 2019 11:32 am

So, the next time we see the onc, I should just directly ask about Foundation one testing?
Mother DX @59 8/14
cln+lvr res 9/14, stage 4
FOLOX+Avs 12-rd 10/14 to 4/15
Reoccurrence, KRAS mutant 11/15
Folfiri 18-rds 11/15-8/16
FOLFIRI with Ramicirumab 28-rds 8/17-9/18
Regorafenib 10/18-10/19
Lonsurf 10/19 onward

Rock_Robster
Posts: 399
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: Ask For Foundation One Test, and Keytruda?

Postby Rock_Robster » Sat Aug 03, 2019 10:04 pm

meatie wrote:So, the next time we see the onc, I should just directly ask about Foundation one testing?

Yes that would be my starting point. If TMB is specifically what you’re after, then maybe ask about this - some places can also test for this (other than Foundation One) so they may be able to organise this for you.

Of course you may still end up needing to organise it yourself, but I presume you would still need your onc’s help with access to biopsies etc?
Male 37; Melbourne, Australia
10/2018 Dx 3.5cm RC adenocarcinoma, 12cm from AV
Mod diff, EMVI+ LVI+ PNI-
3 LN; 4 liver mets
pT3pN1aM1a; Stage IVa. MSS, NRAS (G13R)
CEA: Oct-18= 12; Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0
11/18 - FOLFOX x 6
3/19 - Liver resection
4-5/19 - 25 x pelvic radiation; complete met. response
07/19 - ULAR (robot), temp ileo, 1/27 LN
08/19 - Missed liver spot
08-11/19 - FOLFOX x 1, FOLFOXIRI x 1, FOLFIRI x 5
12/19 - Planned liver resection #2 & (01/20) stoma reversal

Pyro70
Posts: 155
Joined: Mon Jan 21, 2019 4:25 pm

Re: Ask For Foundation One Test, and Keytruda?

Postby Pyro70 » Sun Aug 04, 2019 7:09 pm

Echoing Rob, if you start Keytruda I would strongly consider staying on regorafenib based on the Regonivo results.
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

User avatar
meatie
Posts: 408
Joined: Wed Aug 20, 2014 8:13 am
Location: San Jose, CA

Re: Ask For Foundation One Test, and Keytruda?

Postby meatie » Fri Aug 09, 2019 8:08 pm

Pyro70 wrote:Echoing Rob, if you start Keytruda I would strongly consider staying on regorafenib based on the Regonivo results.


Is there a similar trial that uses Ketruda in place of opdivo?
Mother DX @59 8/14
cln+lvr res 9/14, stage 4
FOLOX+Avs 12-rd 10/14 to 4/15
Reoccurrence, KRAS mutant 11/15
Folfiri 18-rds 11/15-8/16
FOLFIRI with Ramicirumab 28-rds 8/17-9/18
Regorafenib 10/18-10/19
Lonsurf 10/19 onward

Rock_Robster
Posts: 399
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: Ask For Foundation One Test, and Keytruda?

Postby Rock_Robster » Fri Aug 09, 2019 8:54 pm

Meatie are you looking for a trial to participate in, or for results?
Male 37; Melbourne, Australia
10/2018 Dx 3.5cm RC adenocarcinoma, 12cm from AV
Mod diff, EMVI+ LVI+ PNI-
3 LN; 4 liver mets
pT3pN1aM1a; Stage IVa. MSS, NRAS (G13R)
CEA: Oct-18= 12; Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0
11/18 - FOLFOX x 6
3/19 - Liver resection
4-5/19 - 25 x pelvic radiation; complete met. response
07/19 - ULAR (robot), temp ileo, 1/27 LN
08/19 - Missed liver spot
08-11/19 - FOLFOX x 1, FOLFOXIRI x 1, FOLFIRI x 5
12/19 - Planned liver resection #2 & (01/20) stoma reversal

Rock_Robster
Posts: 399
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: Ask For Foundation One Test, and Keytruda?

Postby Rock_Robster » Fri Aug 09, 2019 9:15 pm

And apologies - you’re correct and my earlier post should associate Opdivo with REGONIVO, not Keytruda. Both are PD-1 inhibitors though of course.
Male 37; Melbourne, Australia
10/2018 Dx 3.5cm RC adenocarcinoma, 12cm from AV
Mod diff, EMVI+ LVI+ PNI-
3 LN; 4 liver mets
pT3pN1aM1a; Stage IVa. MSS, NRAS (G13R)
CEA: Oct-18= 12; Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0
11/18 - FOLFOX x 6
3/19 - Liver resection
4-5/19 - 25 x pelvic radiation; complete met. response
07/19 - ULAR (robot), temp ileo, 1/27 LN
08/19 - Missed liver spot
08-11/19 - FOLFOX x 1, FOLFOXIRI x 1, FOLFIRI x 5
12/19 - Planned liver resection #2 & (01/20) stoma reversal

User avatar
meatie
Posts: 408
Joined: Wed Aug 20, 2014 8:13 am
Location: San Jose, CA

Re: Ask For Foundation One Test, and Keytruda?

Postby meatie » Fri Aug 09, 2019 9:16 pm

Rock_Robster wrote:Meatie are you looking for a trial to participate in, or for results?


We would like to participate in a trial.
Mother DX @59 8/14
cln+lvr res 9/14, stage 4
FOLOX+Avs 12-rd 10/14 to 4/15
Reoccurrence, KRAS mutant 11/15
Folfiri 18-rds 11/15-8/16
FOLFIRI with Ramicirumab 28-rds 8/17-9/18
Regorafenib 10/18-10/19
Lonsurf 10/19 onward

Rock_Robster
Posts: 399
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: Ask For Foundation One Test, and Keytruda?

Postby Rock_Robster » Fri Aug 09, 2019 9:23 pm

meatie wrote:
Rock_Robster wrote:Meatie are you looking for a trial to participate in, or for results?


We would like to participate in a trial.

No problem. Below is a link to a Phase I/II trial that is yet to start recruiting in 3 centres...
https://clinicaltrials.gov/ct2/show/NCT03657641

I’ll post more if I can dig anything up.

I’d also comment that as both drugs are already approved for CRC you should be able to access them outside of a trial, although I don’t know how funding would work for the Keytruda.
Male 37; Melbourne, Australia
10/2018 Dx 3.5cm RC adenocarcinoma, 12cm from AV
Mod diff, EMVI+ LVI+ PNI-
3 LN; 4 liver mets
pT3pN1aM1a; Stage IVa. MSS, NRAS (G13R)
CEA: Oct-18= 12; Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0
11/18 - FOLFOX x 6
3/19 - Liver resection
4-5/19 - 25 x pelvic radiation; complete met. response
07/19 - ULAR (robot), temp ileo, 1/27 LN
08/19 - Missed liver spot
08-11/19 - FOLFOX x 1, FOLFOXIRI x 1, FOLFIRI x 5
12/19 - Planned liver resection #2 & (01/20) stoma reversal

Rock_Robster
Posts: 399
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: Ask For Foundation One Test, and Keytruda?

Postby Rock_Robster » Fri Aug 09, 2019 9:32 pm

I haven’t found anything further for that exact drug combo, but there are some other trials using Stivarga and other PD-1 inhibitors (i.e. other than Keytruda and Opdivo). Just let me know if this is interesting.
Male 37; Melbourne, Australia
10/2018 Dx 3.5cm RC adenocarcinoma, 12cm from AV
Mod diff, EMVI+ LVI+ PNI-
3 LN; 4 liver mets
pT3pN1aM1a; Stage IVa. MSS, NRAS (G13R)
CEA: Oct-18= 12; Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0
11/18 - FOLFOX x 6
3/19 - Liver resection
4-5/19 - 25 x pelvic radiation; complete met. response
07/19 - ULAR (robot), temp ileo, 1/27 LN
08/19 - Missed liver spot
08-11/19 - FOLFOX x 1, FOLFOXIRI x 1, FOLFIRI x 5
12/19 - Planned liver resection #2 & (01/20) stoma reversal

Pyro70
Posts: 155
Joined: Mon Jan 21, 2019 4:25 pm

Re: Ask For Foundation One Test, and Keytruda?

Postby Pyro70 » Mon Aug 12, 2019 7:00 pm

meatie wrote:
Pyro70 wrote:Echoing Rob, if you start Keytruda I would strongly consider staying on regorafenib based on the Regonivo results.


Is there a similar trial that uses Ketruda in place of opdivo?


Hi Meatie,

Yes Merck is trying Keytruda with regorafenib in the trial NCT03657641. As i mentioned, in theory Pembrolizumab (Keytruda) and Nivolumab should be interchangeable, but as of now there is no data for the Regorafenib + Pembrolizumab combo.
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak


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