Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

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ForDad
Posts: 82
Joined: Mon Feb 03, 2014 4:13 pm
Location: California

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby ForDad » Fri Jul 05, 2019 11:26 pm

Pyro70 wrote:FYI, I’m reposting from the MSS Facebook group. There are also two trials one can join to test this combo. Pembrolizumab should be equivalent to nivolumab and there is a trial in Southern California and Florida. There is also a trial recruiting in Florida for reg + Opdivo.

NCT03712943 (rego + nivolumab (Brand name Opdivo; anti PD-1))

NCT03657641 (rego + pembrolizumab (Brand name Keytruda (anti PD-1))

Interesting there is also this trial below that is completed, that I would love to see the results for:
NCT03081494 (rego + spartalizumab/PDR001 (experimental anti PD-1 by Novartis))


It’s great to hear of these clinical trials — I hope they yield promising results.

Our onc informed us that in one clinical trial involving regorafenib + nivolumab, the patients are randomly placed into one of two groups: 1) an investigational group that receives both regorafenib + nivolumab and 2) a control group that receives only regorafenib. I do not know if it is the same clinical trial as the one referenced above. In any case, please keep this in mind for anyone considering enrolling in a trial. It is possible for you to be placed in a control group and not even receive the meds you wanted to try.
Daughter to Dad age 67 @dx, Dec. 2013 (now 73)
Stage IV cecum, 4 liver mets, CEA 21.8
MSS, KRAS mutant (G13D), MLH1 mutant (V384D), and TP53 mutant (G245S)
1/14 FOLFOXIRI, 2x
2/14 FOLFOX, 1x
3/14 Right hemicolectomy, 2/38 nodes
4/14 FOLFOX, 4x
8/14 Liver resection
9/14 Liver tumor growth: microwave ablation
10/14 FOLFIRI, 6x
1/15 NED
2/16 8 to 10 lesions in lungs
3/16 Avastin + 5FU, 72x
4/19 Growth in lungs, lymph nodes. FOLFIRI + Avastin, 4x (CEA 12.4)
7/19 Started Stivarga + Opdivo

Pyro70
Posts: 135
Joined: Mon Jan 21, 2019 4:25 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Pyro70 » Sat Jul 06, 2019 6:16 am

ForDad wrote:
Pyro70 wrote:FYI, I’m reposting from the MSS Facebook group. There are also two trials one can join to test this combo. Pembrolizumab should be equivalent to nivolumab and there is a trial in Southern California and Florida. There is also a trial recruiting in Florida for reg + Opdivo.

NCT03712943 (rego + nivolumab (Brand name Opdivo; anti PD-1))

NCT03657641 (rego + pembrolizumab (Brand name Keytruda (anti PD-1))

Interesting there is also this trial below that is completed, that I would love to see the results for:
NCT03081494 (rego + spartalizumab/PDR001 (experimental anti PD-1 by Novartis))


It’s great to hear of these clinical trials — I hope they yield promising results.

Our onc informed us that in one clinical trial involving regorafenib + nivolumab, the patients are randomly placed into one of two groups: 1) an investigational group that receives both regorafenib + nivolumab and 2) a control group that receives only regorafenib. I do not know if it is the same clinical trial as the one referenced above. In any case, please keep this in mind for anyone considering enrolling in a trial. It is possible for you to be placed in a control group and not even receive the meds you wanted to try.


I agree that going the off label route can be better for the patient - insurance reimbursement or getting access to free drugs can be the biggest hurdle. However, for selfish reasons, I don’t like to discourage anyone from doing trials :). And I commend anyone going through trials because not only could they be helping themselves, but also they are helping to advance science.

I just checked the the trials above and none of them have a control arm. Maybe there is another trial I’m not aware of. I would love to see this combo tested in an RCT versus a control arm - it’s the only way to know with certainty that it works - and may be necessary for approval.

I should also note that trials are sometimes criticized for not being realistic because they are a much more controlled environment. Hence the results in trials tend to have better outcomes than in real-world situations. It’s much more unlikely that once enrolled in a trial a doctor would forget to follow up with a patient or not schedule the optimal appointment times. So there are also benefits to patients going through trials....
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

Pyro70
Posts: 135
Joined: Mon Jan 21, 2019 4:25 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Pyro70 » Sat Jul 06, 2019 8:59 am

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

simonseconddone
Posts: 1
Joined: Sun Jul 21, 2019 9:36 am

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby simonseconddone » Sun Jul 21, 2019 9:42 am

Excuse me, Where is the mss facebook ? I want join it

Pyro70
Posts: 135
Joined: Mon Jan 21, 2019 4:25 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Pyro70 » Sun Jul 21, 2019 7:29 pm

simonseconddone wrote:Excuse me, Where is the mss facebook ? I want join it


You can join by registering at:
https://colontown.org/
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

tbt4snow
Posts: 24
Joined: Sat Oct 27, 2018 3:16 pm
Facebook Username: Tina tran

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby tbt4snow » Tue Jul 23, 2019 3:13 pm

Hi,
I just received a letter from Bristol-Myers Squibb approving my application for free Opdivo (Nivoumab). Huge relieve. I applied it directly to the company and the response time is very quick. After they received completed application, the response time is 24 hours. If the application needs to be sent to Patient assistance Foundation, it will take another three to five business days. My onc advised me that I will be having one more folfox+oxi session (#5) then will switch to Regorafenib + Nivolumab.
I will provide update once I'm on the new regime.
Best wishes.
Tina.
DX: CC stage 4/w ovaries & omentum mets in 12/17 49/F
High grade pT3N1bM1b sigmoid Adenocarcinoma colon
MSS-h TMB=16, NRAS-mutant
Lymph nodes: 1/2 left colic; 3/8 regional
12/2017: Exploratory laparotomy & resect of sigmoid & ovaries
Folfox/avastin 12 sessions from 1/8-6/18. 6/18 CEA 2.1
1/19: CT shows peri mets;
CEA: 12/18 5.1, 1/7/19 7.9; 1/15/19 9.1; 1/30/19: 10.6
4/3/2019 CRS/HIPEC after 4 Folfiry sessions...

natelaugh
Posts: 52
Joined: Wed Apr 03, 2019 11:40 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby natelaugh » Tue Jul 23, 2019 3:47 pm

Hi Tina,

That is good. I hope it works for your. Immunotherapy is very expensive.
Nate.
Caregiver to 80M
DX:CC,RC,desc
11/2018 rightPain
1/19/19 scopy,path
1/23 CTscan
2/19 surgery
2/26-2/28 NGTube
2/28-3/14 TPN bc ileus
3/2 2nd surgeryCloseOpenWound
3/4-3/28 woundVac
size: 6cm Adenocarcinoma
grade Poorly
Stage IIIC T3N2aMx
PositiveLymph:5of28
BaselineCEA:68
LVI:Y
PNI:N
Surgical margins:clear
MSI:MMR (MLH1, MSH2, MSH6, PMS2) Intact nuclear expression
Lynch status:N
Laparascopic, partial colectomy
CEA:3/28/19 2.8
Chemo:4/16/19-9/17/19 5FU,12cycles,every 14days,leucoverin,zofran,Dexamethasone

Rikimaroo
Posts: 238
Joined: Tue Dec 20, 2016 8:48 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Rikimaroo » Tue Jul 23, 2019 6:57 pm

What side effects are there with this trial. I understand I also qualify for this trial but wanted to know if there are any sides effects. Did you feel anything while you are doing it?
RC T3N1M0
MSS - NRAS Mutation
Chemo Rad, CCR - W&W 5/2017
Recurrence 11/2017
CT Scan 11/2017 Liver Met 5.5cm Stable, Stage IV
Port Scheduled for 12/2017, folfox - avastin 12/2017
Blood Clot in Neck 1/2018, stop avastin, continue FolFox
LAR/Liver Resect 4/2018
Chemo Finish 8/2018
Reversal 10/18
CEA - 12/16 26.1, 1/17 32.2, 3/17 6.6, 11/17 500.5, 12/17 638.5, 1/3/18 424.8, 1/16/18 163.5, 1/31/18 62.2, 2/18 21.1, 3/18 14, 4/18 .8, 10/18 1.2, 12/18 3.2, 2/8 11.4, 3/6 22

Pyro70
Posts: 135
Joined: Mon Jan 21, 2019 4:25 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Pyro70 » Thu Jul 25, 2019 9:24 am

tbt4snow wrote:Hi,
I just received a letter from Bristol-Myers Squibb approving my application for free Opdivo (Nivoumab). Huge relieve. I applied it directly to the company and the response time is very quick. After they received completed application, the response time is 24 hours. If the application needs to be sent to Patient assistance Foundation, it will take another three to five business days. My onc advised me that I will be having one more folfox+oxi session (#5) then will switch to Regorafenib + Nivolumab.
I will provide update once I'm on the new regime.
Best wishes.
Tina.


Tina, thank you so much for keeping us updated. It’s good to know that BMS is paying for this in some cases. Could you give us more details on what is required for the application? Is approval for free drug access based on the patient’s financial resources/ability to pay? Are there other criteria they base the approval on?

Many thanks!
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

tbt4snow
Posts: 24
Joined: Sat Oct 27, 2018 3:16 pm
Facebook Username: Tina tran

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby tbt4snow » Thu Jul 25, 2019 11:54 am

Hi,
I'm on LTD. I have state health insurance plan. They didn't ask for my tax info, only my health insurance info. It looks like the process go must faster if patient applies directly rather than through doctor's office. Obviously, onc will have to fill out all the info but you can follow up with BMS to know where your application stands and if your doctor has submit all required paper work.
Hope this help.
Tina.
DX: CC stage 4/w ovaries & omentum mets in 12/17 49/F
High grade pT3N1bM1b sigmoid Adenocarcinoma colon
MSS-h TMB=16, NRAS-mutant
Lymph nodes: 1/2 left colic; 3/8 regional
12/2017: Exploratory laparotomy & resect of sigmoid & ovaries
Folfox/avastin 12 sessions from 1/8-6/18. 6/18 CEA 2.1
1/19: CT shows peri mets;
CEA: 12/18 5.1, 1/7/19 7.9; 1/15/19 9.1; 1/30/19: 10.6
4/3/2019 CRS/HIPEC after 4 Folfiry sessions...

Pyro70
Posts: 135
Joined: Mon Jan 21, 2019 4:25 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Pyro70 » Sat Jul 27, 2019 2:09 pm

tbt4snow wrote:Hi,
I'm on LTD. I have state health insurance plan. They didn't ask for my tax info, only my health insurance info. It looks like the process go must faster if patient applies directly rather than through doctor's office. Obviously, onc will have to fill out all the info but you can follow up with BMS to know where your application stands and if your doctor has submit all required paper work.
Hope this help.
Tina.



Thanks a lot for this info. A basic question, how did you get the application In the first place? Did you find it on BMS’s website? Also, if BMS supplies the drug for free, to my understanding there is still the cost of administering the drug. I guess insurance won’t pay for that either. Are you paying out of pocket or is your doctor’s office covering the cost? Sorry for these detailed questions, I think it’s helpful to know though for those of us that are considering this combo.

I’m also helping to track patient results to this combo for the Tom’s MSS clinical trials FB group. If you don’t mind sharing your own results and I’ll include them in the data.

Thanks!
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

tbt4snow
Posts: 24
Joined: Sat Oct 27, 2018 3:16 pm
Facebook Username: Tina tran

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby tbt4snow » Wed Jul 31, 2019 9:04 am

Hi,
The application is from BMS. Here is the link for it:
http://www.bmspaf.org/Documents/OncologyApplication.pdf
I'm not sure about the fee for administering the drug at hospital. I will ask my onc next time I see him. It might vary based on your insurance policy. Before I get approve for the drug, I ask BMS about the cost of the drug and they said it is set by the hospital. So I asked my onc and he said it would cost about $150K/year for Nivolumab if we have to pay out of pocket.
I will update how it goes once I'm on this new combo.
Tina.
DX: CC stage 4/w ovaries & omentum mets in 12/17 49/F
High grade pT3N1bM1b sigmoid Adenocarcinoma colon
MSS-h TMB=16, NRAS-mutant
Lymph nodes: 1/2 left colic; 3/8 regional
12/2017: Exploratory laparotomy & resect of sigmoid & ovaries
Folfox/avastin 12 sessions from 1/8-6/18. 6/18 CEA 2.1
1/19: CT shows peri mets;
CEA: 12/18 5.1, 1/7/19 7.9; 1/15/19 9.1; 1/30/19: 10.6
4/3/2019 CRS/HIPEC after 4 Folfiry sessions...

ForDad
Posts: 82
Joined: Mon Feb 03, 2014 4:13 pm
Location: California

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby ForDad » Wed Jul 31, 2019 6:42 pm

My dad started Stivarga and Opdivo on July 19. He takes 2 Stivarga pills (80mg) per day, and receives his Opdivo infusion once every 2 weeks. The infusion lasts about 30 minutes. After 3 weeks of Stivarga, he will take 1 week break, and then get back on Stivarga for 3 weeks, etc.

The side effects so far have included fatigue, muscle aches, and occasional diarrhea. He also had nausea for about a day, but that went away with Ondansetron. He has not yet had any hand-and-foot syndrome. My dad says that this regimen is much more tolerable compared to FOLFIRI and FOLFOX. He also has very good appetite, and I’m hoping that he will be able to gain back some of the weight that he lost during FOLFIRI.

We were approved for free Opdivo through the end of 2019. Our oncologist filled out all the paperwork, and I am not sure what happens in 2020… I assume we will need to re-apply.

I am keeping my fingers crossed that this will be an effective treatment for my dad as well as everyone else who goes on it.
Daughter to Dad age 67 @dx, Dec. 2013 (now 73)
Stage IV cecum, 4 liver mets, CEA 21.8
MSS, KRAS mutant (G13D), MLH1 mutant (V384D), and TP53 mutant (G245S)
1/14 FOLFOXIRI, 2x
2/14 FOLFOX, 1x
3/14 Right hemicolectomy, 2/38 nodes
4/14 FOLFOX, 4x
8/14 Liver resection
9/14 Liver tumor growth: microwave ablation
10/14 FOLFIRI, 6x
1/15 NED
2/16 8 to 10 lesions in lungs
3/16 Avastin + 5FU, 72x
4/19 Growth in lungs, lymph nodes. FOLFIRI + Avastin, 4x (CEA 12.4)
7/19 Started Stivarga + Opdivo

Pyro70
Posts: 135
Joined: Mon Jan 21, 2019 4:25 pm

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby Pyro70 » Fri Aug 02, 2019 9:58 pm

ForDad wrote:My dad started Stivarga and Opdivo on July 19. He takes 2 Stivarga pills (80mg) per day, and receives his Opdivo infusion once every 2 weeks. The infusion lasts about 30 minutes. After 3 weeks of Stivarga, he will take 1 week break, and then get back on Stivarga for 3 weeks, etc.

The side effects so far have included fatigue, muscle aches, and occasional diarrhea. He also had nausea for about a day, but that went away with Ondansetron. He has not yet had any hand-and-foot syndrome. My dad says that this regimen is much more tolerable compared to FOLFIRI and FOLFOX. He also has very good appetite, and I’m hoping that he will be able to gain back some of the weight that he lost during FOLFIRI.

We were approved for free Opdivo through the end of 2019. Our oncologist filled out all the paperwork, and I am not sure what happens in 2020… I assume we will need to re-apply.

I am keeping my fingers crossed that this will be an effective treatment for my dad as well as everyone else who goes on it.


Thank you for this post. It’s encouraging to hear that this regimen is more tolerable than FOLFOX or FOLFIRI. I’m helping to track a number of patients responses to this regimen for the MSS Facebook group. Hopefully you won’t mind sharing future updates on efficacy and side effects so that I can include you in the results as well. I plan to share the results here as well in a few months, once patients have their first scans.

Was the approval for Opdivo from BMS or your insurance? Do you mind also sharing what kind of insurance your dad has?

Best of luck with future scans! Also did your dad’s oncologist suggest this approach or did you have to push for it?

Many thanks!
Ben
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

ForDad
Posts: 82
Joined: Mon Feb 03, 2014 4:13 pm
Location: California

Re: Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

Postby ForDad » Sun Aug 11, 2019 11:49 am

Pyro70 wrote:Thank you for this post. It’s encouraging to hear that this regimen is more tolerable than FOLFOX or FOLFIRI. I’m helping to track a number of patients responses to this regimen for the MSS Facebook group. Hopefully you won’t mind sharing future updates on efficacy and side effects so that I can include you in the results as well. I plan to share the results here as well in a few months, once patients have their first scans.

Was the approval for Opdivo from BMS or your insurance? Do you mind also sharing what kind of insurance your dad has?

Best of luck with future scans! Also did your dad’s oncologist suggest this approach or did you have to push for it?

Many thanks!
Ben


Apologies for the slow reply, Ben. To answer your questions:

1) The approval for Opdivo came directly from BMS. My dad has Medicare and Medicaid.
2) Our oncologist recommended this approach. We did not bring it up with him.

Week 3 side effects: The fatigue is worse, and my dad also has quite a few mouth sores. (He also had mouth sores from FOLFIRI). My dad says that eating food feels like eating sand (gritty). His appetite isn't great but he is eating nonetheless. His voice is also soft and hoarse.

I will continue to update.
Daughter to Dad age 67 @dx, Dec. 2013 (now 73)
Stage IV cecum, 4 liver mets, CEA 21.8
MSS, KRAS mutant (G13D), MLH1 mutant (V384D), and TP53 mutant (G245S)
1/14 FOLFOXIRI, 2x
2/14 FOLFOX, 1x
3/14 Right hemicolectomy, 2/38 nodes
4/14 FOLFOX, 4x
8/14 Liver resection
9/14 Liver tumor growth: microwave ablation
10/14 FOLFIRI, 6x
1/15 NED
2/16 8 to 10 lesions in lungs
3/16 Avastin + 5FU, 72x
4/19 Growth in lungs, lymph nodes. FOLFIRI + Avastin, 4x (CEA 12.4)
7/19 Started Stivarga + Opdivo


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