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

Posted: Fri Jul 05, 2019 11:26 pm
by ForDad
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.

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

Posted: Sat Jul 06, 2019 6:16 am
by Pyro70
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....

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

Posted: Sat Jul 06, 2019 8:59 am
by Pyro70

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

Posted: Sun Jul 21, 2019 9:42 am
by simonseconddone
Excuse me, Where is the mss facebook ? I want join it

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

Posted: Sun Jul 21, 2019 7:29 pm
by Pyro70
simonseconddone wrote:Excuse me, Where is the mss facebook ? I want join it


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

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

Posted: Tue Jul 23, 2019 3:13 pm
by tbt4snow
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.

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

Posted: Tue Jul 23, 2019 3:47 pm
by natelaugh
Hi Tina,

That is good. I hope it works for your. Immunotherapy is very expensive.
Nate.

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

Posted: Tue Jul 23, 2019 6:57 pm
by Rikimaroo
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?

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

Posted: Thu Jul 25, 2019 9:24 am
by Pyro70
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!

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

Posted: Thu Jul 25, 2019 11:54 am
by tbt4snow
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.

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

Posted: Sat Jul 27, 2019 2:09 pm
by Pyro70
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!

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

Posted: Wed Jul 31, 2019 9:04 am
by tbt4snow
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.

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

Posted: Wed Jul 31, 2019 6:42 pm
by ForDad
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.

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

Posted: Fri Aug 02, 2019 9:58 pm
by Pyro70
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

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

Posted: Sun Aug 11, 2019 11:49 am
by ForDad
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.