Regorafenib + Nivolumab - Immunotherapy might work in MSS CRC

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ForDad
Posts: 80
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 Will start Stivarga + Opdivo

Pyro70
Posts: 118
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: 118
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: 118
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


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