› Forums › General Melanoma Community › Is anyone itaking CDX-011 (glembatumumab vedotin) in a clinical trial?
- This topic has 36 replies, 4 voices, and was last updated 7 years, 11 months ago by
gostan.
- Post
-
- January 12, 2016 at 12:41 pm
I may be starting a clinical trial using glembatumumab – vedotum. I was wondering if anyone had any experience with this drug? Side effects/ opinion. I'm braf negative. The oncologist is also trying to see if she ca get my insurance to pay for MEK Inhibitor. Any opinions the MEK inhibitor?
thanks,
scot
- Replies
-
-
- January 12, 2016 at 1:48 pm
Is that a Duke trial Scot?
You've probably seen this but I pulled this off the Celldex website:
Melanomas Expressing gpNMB
More than 85% of patients with metastatic melanoma express gpNMB, making it an attractive target for study of glembatumumab vedotin. In 2010, data from a Phase 2 study of glembatumumab vedotin were presented at the American Society of Clinical Oncology Annual Meeting which demonstrated significant activity in advanced melanoma patients. In the study, the primary activity endpoint of overall response rate (ORR) was achieved with an ORR of 15% (5/34). Median progression free survival (PFS) was 3.9 months. More frequent dosing schedules were evaluated in two additional, parallel dose-escalation arms in which patients received glembatumumab vedotin weekly or twice every three weeks. At the maximum tolerated doses in these schedules, the response rate was observed to be 20% (n=15) and 33% (n=6), respectively. Preliminary data suggest an increase in PFS in patients with high tumoral gpNMB expression. The subset of seven patients, whose tumors were found to express high amounts of gpNMB, and who were treated at the maximum tolerated doses across all dosing schedules, demonstrated a median PFS of 4.9 months. In December 2014, the Company initiated an open-label Phase 2 study of glembatumumab vedotin in patients with unresectable Stage III or IV melanoma.
-
- January 12, 2016 at 2:47 pm
Brian thanks for your reply. Yes this is at Duke. I went to a consult yesterday with Dr. Salama. My wife and I both liked her and she was very knowledgeable about my current situation and was inline with what we have researched. I still have to take a bunch of tests to see if I meet the requirements. Dr. Salama is also going to try to get me on the MEK inhibitor to parallel with the clinical trial if my insurance will pay for it.
thanks,
scot
-
- January 12, 2016 at 2:47 pm
Brian thanks for your reply. Yes this is at Duke. I went to a consult yesterday with Dr. Salama. My wife and I both liked her and she was very knowledgeable about my current situation and was inline with what we have researched. I still have to take a bunch of tests to see if I meet the requirements. Dr. Salama is also going to try to get me on the MEK inhibitor to parallel with the clinical trial if my insurance will pay for it.
thanks,
scot
-
- January 12, 2016 at 2:47 pm
Brian thanks for your reply. Yes this is at Duke. I went to a consult yesterday with Dr. Salama. My wife and I both liked her and she was very knowledgeable about my current situation and was inline with what we have researched. I still have to take a bunch of tests to see if I meet the requirements. Dr. Salama is also going to try to get me on the MEK inhibitor to parallel with the clinical trial if my insurance will pay for it.
thanks,
scot
-
- January 12, 2016 at 3:41 pm
Definitely seems like she's thinking outside the box. I'm surprised the trial would allow a second treatment to be given at the same time.
Dr. Salama definitely impressed me on my last visit. I think I may have gotten her on a bad day a few years ago. Good luck with the screening.
-
- January 12, 2016 at 4:44 pm
It sounded like we would parallel both, but I may misunderstood. It sounded like there were a lot hoops to jump through to get through that drug. After we got home and were talking about it I thought it may not be possible on the trail. A question for next visit if I go with the trial. From our talk with the Doctor it was very important to get this under control as quickly as possible do to the fact that cancer is growing quickly(liver). Thanks for your help.
-
- January 12, 2016 at 4:44 pm
It sounded like we would parallel both, but I may misunderstood. It sounded like there were a lot hoops to jump through to get through that drug. After we got home and were talking about it I thought it may not be possible on the trail. A question for next visit if I go with the trial. From our talk with the Doctor it was very important to get this under control as quickly as possible do to the fact that cancer is growing quickly(liver). Thanks for your help.
-
- January 12, 2016 at 4:44 pm
It sounded like we would parallel both, but I may misunderstood. It sounded like there were a lot hoops to jump through to get through that drug. After we got home and were talking about it I thought it may not be possible on the trail. A question for next visit if I go with the trial. From our talk with the Doctor it was very important to get this under control as quickly as possible do to the fact that cancer is growing quickly(liver). Thanks for your help.
-
- January 12, 2016 at 6:00 pm
Scot,
Just read your profile. You have certainly had a tough road. I saw where you listed UVA medical center in your profile. Have you talked with any of their specialist recently? I found the below trial on their website:
14-16954 Other: Externally Peer-Reviewed CITN-04
Stages: III; IV CT.GOV ID: NCT01961115
A Phase II Pilot Trial of an Indoleamine2,3, dioxygenase-1 (IDO1) Inhibitor(INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients with Advanced MelanomaI don't know if it's still recruiting nor do I know much about IDO inhibitors but a while back I remember seeing promising results in early trials.
Is the liver the only problem spot right now? Wondering if there are other tumors that could be resected in order to do some type of TIL treatment.
Have you considered going up to NCI?
Sorry for all the questions. Feel free to ignore.
Brian
-
- January 12, 2016 at 6:00 pm
Scot,
Just read your profile. You have certainly had a tough road. I saw where you listed UVA medical center in your profile. Have you talked with any of their specialist recently? I found the below trial on their website:
14-16954 Other: Externally Peer-Reviewed CITN-04
Stages: III; IV CT.GOV ID: NCT01961115
A Phase II Pilot Trial of an Indoleamine2,3, dioxygenase-1 (IDO1) Inhibitor(INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients with Advanced MelanomaI don't know if it's still recruiting nor do I know much about IDO inhibitors but a while back I remember seeing promising results in early trials.
Is the liver the only problem spot right now? Wondering if there are other tumors that could be resected in order to do some type of TIL treatment.
Have you considered going up to NCI?
Sorry for all the questions. Feel free to ignore.
Brian
-
- January 12, 2016 at 6:00 pm
Scot,
Just read your profile. You have certainly had a tough road. I saw where you listed UVA medical center in your profile. Have you talked with any of their specialist recently? I found the below trial on their website:
14-16954 Other: Externally Peer-Reviewed CITN-04
Stages: III; IV CT.GOV ID: NCT01961115
A Phase II Pilot Trial of an Indoleamine2,3, dioxygenase-1 (IDO1) Inhibitor(INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients with Advanced MelanomaI don't know if it's still recruiting nor do I know much about IDO inhibitors but a while back I remember seeing promising results in early trials.
Is the liver the only problem spot right now? Wondering if there are other tumors that could be resected in order to do some type of TIL treatment.
Have you considered going up to NCI?
Sorry for all the questions. Feel free to ignore.
Brian
-
- January 12, 2016 at 6:42 pm
I went to UVA to have the melanoma removed from a head and neck specialist. When I found out they had a melanoma specialist they would not see me because I was Ned so I have never seen the UVA melanoma specialist. I may need to look into them again. The liver is the main problem, but I do have two small spots on the lung as of the last scan. Hopefully the last two chemo treatments took care of them, but I need a new ct scan to find out if the chemo slowed the progression down. Dr. Salama did discuss TIL but she had two issues for me….. Most centers have discontinued that treatment. She said MD Anderson still performed that treatment. She also did not think I had the time it takes for this treatment to get setup and my current condition. From what I have been told it takes 3 months to grow the tills. She believes I need to get into a treatment as soon as possible. I have also looked at NIH. We are submitting the forms to NIH today to see if they have any trials for me. It looks like it will take some time to go through the process, but at least the process is started now. I do not mind the questions.
thanks for your concern,
scot
-
- January 12, 2016 at 6:42 pm
I went to UVA to have the melanoma removed from a head and neck specialist. When I found out they had a melanoma specialist they would not see me because I was Ned so I have never seen the UVA melanoma specialist. I may need to look into them again. The liver is the main problem, but I do have two small spots on the lung as of the last scan. Hopefully the last two chemo treatments took care of them, but I need a new ct scan to find out if the chemo slowed the progression down. Dr. Salama did discuss TIL but she had two issues for me….. Most centers have discontinued that treatment. She said MD Anderson still performed that treatment. She also did not think I had the time it takes for this treatment to get setup and my current condition. From what I have been told it takes 3 months to grow the tills. She believes I need to get into a treatment as soon as possible. I have also looked at NIH. We are submitting the forms to NIH today to see if they have any trials for me. It looks like it will take some time to go through the process, but at least the process is started now. I do not mind the questions.
thanks for your concern,
scot
-
- January 12, 2016 at 6:42 pm
I went to UVA to have the melanoma removed from a head and neck specialist. When I found out they had a melanoma specialist they would not see me because I was Ned so I have never seen the UVA melanoma specialist. I may need to look into them again. The liver is the main problem, but I do have two small spots on the lung as of the last scan. Hopefully the last two chemo treatments took care of them, but I need a new ct scan to find out if the chemo slowed the progression down. Dr. Salama did discuss TIL but she had two issues for me….. Most centers have discontinued that treatment. She said MD Anderson still performed that treatment. She also did not think I had the time it takes for this treatment to get setup and my current condition. From what I have been told it takes 3 months to grow the tills. She believes I need to get into a treatment as soon as possible. I have also looked at NIH. We are submitting the forms to NIH today to see if they have any trials for me. It looks like it will take some time to go through the process, but at least the process is started now. I do not mind the questions.
thanks for your concern,
scot
-
- January 12, 2016 at 3:41 pm
Definitely seems like she's thinking outside the box. I'm surprised the trial would allow a second treatment to be given at the same time.
Dr. Salama definitely impressed me on my last visit. I think I may have gotten her on a bad day a few years ago. Good luck with the screening.
-
- January 12, 2016 at 3:41 pm
Definitely seems like she's thinking outside the box. I'm surprised the trial would allow a second treatment to be given at the same time.
Dr. Salama definitely impressed me on my last visit. I think I may have gotten her on a bad day a few years ago. Good luck with the screening.
-
- January 12, 2016 at 1:48 pm
Is that a Duke trial Scot?
You've probably seen this but I pulled this off the Celldex website:
Melanomas Expressing gpNMB
More than 85% of patients with metastatic melanoma express gpNMB, making it an attractive target for study of glembatumumab vedotin. In 2010, data from a Phase 2 study of glembatumumab vedotin were presented at the American Society of Clinical Oncology Annual Meeting which demonstrated significant activity in advanced melanoma patients. In the study, the primary activity endpoint of overall response rate (ORR) was achieved with an ORR of 15% (5/34). Median progression free survival (PFS) was 3.9 months. More frequent dosing schedules were evaluated in two additional, parallel dose-escalation arms in which patients received glembatumumab vedotin weekly or twice every three weeks. At the maximum tolerated doses in these schedules, the response rate was observed to be 20% (n=15) and 33% (n=6), respectively. Preliminary data suggest an increase in PFS in patients with high tumoral gpNMB expression. The subset of seven patients, whose tumors were found to express high amounts of gpNMB, and who were treated at the maximum tolerated doses across all dosing schedules, demonstrated a median PFS of 4.9 months. In December 2014, the Company initiated an open-label Phase 2 study of glembatumumab vedotin in patients with unresectable Stage III or IV melanoma.
-
- January 12, 2016 at 1:48 pm
Is that a Duke trial Scot?
You've probably seen this but I pulled this off the Celldex website:
Melanomas Expressing gpNMB
More than 85% of patients with metastatic melanoma express gpNMB, making it an attractive target for study of glembatumumab vedotin. In 2010, data from a Phase 2 study of glembatumumab vedotin were presented at the American Society of Clinical Oncology Annual Meeting which demonstrated significant activity in advanced melanoma patients. In the study, the primary activity endpoint of overall response rate (ORR) was achieved with an ORR of 15% (5/34). Median progression free survival (PFS) was 3.9 months. More frequent dosing schedules were evaluated in two additional, parallel dose-escalation arms in which patients received glembatumumab vedotin weekly or twice every three weeks. At the maximum tolerated doses in these schedules, the response rate was observed to be 20% (n=15) and 33% (n=6), respectively. Preliminary data suggest an increase in PFS in patients with high tumoral gpNMB expression. The subset of seven patients, whose tumors were found to express high amounts of gpNMB, and who were treated at the maximum tolerated doses across all dosing schedules, demonstrated a median PFS of 4.9 months. In December 2014, the Company initiated an open-label Phase 2 study of glembatumumab vedotin in patients with unresectable Stage III or IV melanoma.
-
- January 13, 2016 at 1:39 am
Hi Scot,
I have not had any ADC treatment, though a dear one of mine has. Here is an older report on CDX-011:
And a slightly more updated report: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/10/another-antibody-drug-conjugate-for.html
I don't know how much that will help you. Choosing treatment is always difficult and personal. I wish you my best. Celeste
-
- January 13, 2016 at 1:39 am
Hi Scot,
I have not had any ADC treatment, though a dear one of mine has. Here is an older report on CDX-011:
And a slightly more updated report: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/10/another-antibody-drug-conjugate-for.html
I don't know how much that will help you. Choosing treatment is always difficult and personal. I wish you my best. Celeste
-
- May 3, 2016 at 6:03 pm
I am in a clinical trial of Glemb at Dana Farber. I started at highest does but side effects of rash and nausea were pretty bad and they reduced my doseage. I get infused every 3 weeks and body and brain scans every 6 weeks. First scans showed no progression. Current side effects are itch and joint pain. All tolerable. Standard immunotherapy treatments really did not work with my body chemistry, but Brad/meek worked for about 14 months. Next scans are next week. So far I am glad that I took a leap of faith.
-
- May 3, 2016 at 6:03 pm
I am in a clinical trial of Glemb at Dana Farber. I started at highest does but side effects of rash and nausea were pretty bad and they reduced my doseage. I get infused every 3 weeks and body and brain scans every 6 weeks. First scans showed no progression. Current side effects are itch and joint pain. All tolerable. Standard immunotherapy treatments really did not work with my body chemistry, but Brad/meek worked for about 14 months. Next scans are next week. So far I am glad that I took a leap of faith.
-
- May 3, 2016 at 6:03 pm
I am in a clinical trial of Glemb at Dana Farber. I started at highest does but side effects of rash and nausea were pretty bad and they reduced my doseage. I get infused every 3 weeks and body and brain scans every 6 weeks. First scans showed no progression. Current side effects are itch and joint pain. All tolerable. Standard immunotherapy treatments really did not work with my body chemistry, but Brad/meek worked for about 14 months. Next scans are next week. So far I am glad that I took a leap of faith.
-
- January 13, 2016 at 1:39 am
Hi Scot,
I have not had any ADC treatment, though a dear one of mine has. Here is an older report on CDX-011:
And a slightly more updated report: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/10/another-antibody-drug-conjugate-for.html
I don't know how much that will help you. Choosing treatment is always difficult and personal. I wish you my best. Celeste
- You must be logged in to reply to this topic.