Any body knows of Clinical trials for BRAF 600?

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violet9583
Posts: 7
Joined: Tue Feb 27, 2018 12:04 pm

Any body knows of Clinical trials for BRAF 600?

Postby violet9583 » Tue Aug 21, 2018 10:50 am

My wife had 8 rounds of FOLFOX + ERBUTAX and 4 rounds of FOLFIRI + ERBUTAX but the recent scans showed new tumors in the peritoneum. Oncologist wants her to stop Conventional Chemo and start with clinical trials. We live in DFW area. Does any one know of promising clinical trials for BRAF mutation for colon cancer?

NHMike
Posts: 2086
Joined: Fri Jul 21, 2017 3:43 am

Re: Any body knows of Clinical trials for BRAF 600?

Postby NHMike » Tue Aug 21, 2018 8:57 pm

This is a list of BRAF V600E trials at Mass General Hospital in Boston. There are other BRAF 600 variant trials on that page as well. The NCT numbers are listed so you can cross-reference those with any local hospitals.

BRAF V600E is a tough mutation.

http://targetedcancercare.massgeneral.o ... (c-1799T-A).aspx
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

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Tue Sep 18, 2018 6:11 pm

violet9583 wrote:My wife had 8 rounds of FOLFOX + ERBUTAX and 4 rounds of FOLFIRI + ERBUTAX but the recent scans showed new tumors in the peritoneum. Oncologist wants her to stop Conventional Chemo and start with clinical trials. We live in DFW area. Does any one know of promising clinical trials for BRAF mutation for colon cancer?


I’m going to be starting this phase 3 trial soon for braf v600e mutation:

https://clinicaltrials.gov/ct2/show/NCT02928224
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

NHMike
Posts: 2086
Joined: Fri Jul 21, 2017 3:43 am

Re: Any body knows of Clinical trials for BRAF 600?

Postby NHMike » Tue Sep 18, 2018 7:04 pm

Steph20021 wrote:
violet9583 wrote:My wife had 8 rounds of FOLFOX + ERBUTAX and 4 rounds of FOLFIRI + ERBUTAX but the recent scans showed new tumors in the peritoneum. Oncologist wants her to stop Conventional Chemo and start with clinical trials. We live in DFW area. Does any one know of promising clinical trials for BRAF mutation for colon cancer?


I’m going to be starting this phase 3 trial soon for braf v600e mutation:

https://clinicaltrials.gov/ct2/show/NCT02928224


Best wishes on the clinical trial. Please keep us informed on your progress.
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

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Tue Sep 18, 2018 8:45 pm

Thanks Mike. I will for sure check in often and keep you all posted.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Mon Nov 05, 2018 7:08 pm

I am finally starting the Beacon trial tomorrow. I got randomized into the doublet arm so I’ll be receiving the encorafenib (oral pill) and cetuximab (infusion) but not the binimetinib in the triplet arm. Oh well. Better than the control I guess, fingers crossed. I’ll let you know how it goes.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

NHMike
Posts: 2086
Joined: Fri Jul 21, 2017 3:43 am

Re: Any body knows of Clinical trials for BRAF 600?

Postby NHMike » Mon Nov 05, 2018 9:09 pm

You've been through a very tough time. I hope that this trial works for you.
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

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Wed Nov 07, 2018 2:50 pm

Beacon Trial update:
Started the trial yesterday (double arm-encorafenib And Cetuximab) and finished the infusion about 430pm and started vomiting with a killer migraine at 5:30pm. No premeds were given-is this normal? Called the oncall last night and got ondansetron late last night.
It was a terrible night and the migraine has been constant.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Wed Nov 07, 2018 2:53 pm

NHMike wrote:You've been through a very tough time. I hope that this trial works for you.

Thanks Mike. I really hope it helps too. It has been quite the journey these last 4.5+ years I have to say. There was a lot of human error which resulted in a delay of starting the beacon trial but I’m glad to finally have it underway.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Sat Nov 10, 2018 9:45 am

Beacon Trial Update:
CYCLE 1:
Night 1- lots of vomiting all night and a blinding migraine
Day 2-still a terrible migraine
Day 3-headache and body aches but I go to work; I believe I start to get a couple red welts and pimples on my face and going down my neck a bit
Day 4- body aches worsen to extremely painful arms and legs and hips and so I keep wanting to keep moving and shaking out my legs and arms but nothing helps, pins and needles behind my knees and elbows making it so I can’t walk (diagnosed with a bladder infection and I asked for a litre of saline to help my kidneys as I felt I was dehydrated but all my electeolytes came back normal. Given an antibiotic for bladder and naproxen for body aches).
My trial nurse told me to give the encorafenib a break for a couple of days to see if it’s the cause of the pins and needles and painful extremities. So I skipped the pills in day 4 and will today on day 5 too.

CYCLE 2: Went so smoothly!! No nausea, vomit or migraine at all. The acne-like rash still on my face and has gotten slightly worse.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Sat Dec 08, 2018 6:54 pm

The trial continues to go smoothly. The only side effects I have are drowsiness/fatigue which could be caused by my pain pump actually and receiving more medicine than I actually need as my pain has gone way down. I use only one bolus a week and before about 3 a day. The rash is still only on my face and the medicated lotion keeps the redness down and the itchy away. My cea dropped at least 3.5 with the first two cycles. It wasn’t taken right when I started but a month before which is why I say at least 3.5 down after two cycles/two weeks.
My first scan is on December 18th and I can’t wait because all signs to me point to this trial working at shrinking my cancer. I’ll keep you posted with my results.
I’m curious if like chemo this stuff (encorafenib pills and the infusion of erbitux) could potentially work until a point and the stop working? I am guessing yes since in the safety study only 10% had complete response.
I can’t wait for my scan!!! Two more weeks!
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

NHMike
Posts: 2086
Joined: Fri Jul 21, 2017 3:43 am

Re: Any body knows of Clinical trials for BRAF 600?

Postby NHMike » Sat Dec 08, 2018 8:10 pm

Steph20021 wrote:The trial continues to go smoothly. The only side effects I have are drowsiness/fatigue which could be caused by my pain pump actually and receiving more medicine than I actually need as my pain has gone way down. I use only one bolus a week and before about 3 a day. The rash is still only on my face and the medicated lotion keeps the redness down and the itchy away. My cea dropped at least 3.5 with the first two cycles. It wasn’t taken right when I started but a month before which is why I say at least 3.5 down after two cycles/two weeks.
My first scan is on December 18th and I can’t wait because all signs to me point to this trial working at shrinking my cancer. I’ll keep you posted with my results.
I’m curious if like chemo this stuff (encorafenib pills and the infusion of erbitux) could potentially work until a point and the stop working? I am guessing yes since in the safety study only 10% had complete response.
I can’t wait for my scan!!! Two more weeks!


This is great news.

Yes, cancer can mutate to get around chemo but that doesn't mean that it will necessarily happen in your case. I have a co-worker that it did happen to but his doctors expected the mutation and had another drug for the other mutation. His tumor shrank about 50% and is stable there which means that he has to continue taking the drug to prevent the tumor from growing. He has been taking it for 1.5 years and is doing fine on it - he works full-time. And hopefully there is a full cure down the road or it becomes possible to remove it with surgery.
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

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Wed Dec 26, 2018 9:37 am

I am still waiting to see the report from my first CT since starting the Beacon trial but I wanted to share some news. A reminder that I’m in the arm of trial with cetuximab and encorafenib.
On November 20 my CEA was 15.9 and on December 24 (after 5 cycles) it was down to 5.1!!! I haven’t been this low since after my surgeries!
My nurse said she can’t show me the report yet but that the largest tumour has shown a small bit of shrinkage as has the one in my abdomen wall that used to cause pain, everything else is stable. No new spots and no growth.
I’ll post once I’ve seen the report myself.

Also they removed two moles that had changed and sent them to biopsy as this trial does cause skin toxicity and benign squamous cell carcinoma.
Last edited by Steph20021 on Wed Dec 26, 2018 9:50 am, edited 2 times in total.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

NHMike
Posts: 2086
Joined: Fri Jul 21, 2017 3:43 am

Re: Any body knows of Clinical trials for BRAF 600?

Postby NHMike » Wed Dec 26, 2018 9:41 am

Steph20021 wrote:I am still waiting to see the report from my first CT since starting the Beacon trial but I wanted to share some news. A reminder that I’m in the arm of trial with ceruximab and encorafenib.
On November 20 my CEA was 15.9 and on December 24 (after 5 cycles) it was down to 5.1!!! I haven’t been this low since after my surgeries!
My nurse said she can’t show me the report yet but that the largest rumour has shown a small bit of shrinkage as has the one in my abdomen wall that used to cause pain, everything else is stable. No new spots and no growth.
I’ll post once I’ve seen the report myself.

Also they removed two moles that had changed and sent them to biopsy as this trial does cause skin toxicity and benign squamous cell carcinoma.


That's a pretty big drop and almost back to normal. Hope that the progress continues.
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

Steph20021
Posts: 553
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Any body knows of Clinical trials for BRAF 600?

Postby Steph20021 » Wed Dec 26, 2018 9:49 am

NHMike, I am thrilled, but yes I hope the shrinkage continues because with folfox and folfiri I only saw shrinkage with my first scan and from that point on they only kept me stable. I am really hoping this isn’t the same.
I’d love to hear from someone who was in my arm of the study and had lasting positive results.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab


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