clinical trial GM-CSF/Yervoy

Hi,

I'm currently on Yervoy (labled dose, not the higher trial dose), but my doctor tacked on GM-CSF for 14 days after each infusion based on preliminary data from a trial like the one you're describing. The reason he added the GM-CSF was because the preliminary data showed that people on the combo (Yervoy plus GM-CSF) actually had fewer side effects compared to those just getting the Yervoy by itself. The data also indicated (though it's very early yet) that while it didn't make a person more likely to respond to therapy, for those that did respond the combo group seemed to have a longer lasting responses. Based on that, there didn't seem to be a down side- possibly fewer side effects and maybe a better/longer response so we added it to my therapy. It did take some convincing with the insurance company, but I'm currently on that combo.

Keeping in mind that I am on the lower labled dose, not the much higher dose typically used in recent trials, my side effects have really been pretty minimal. I also started WBR at the same time and I think many of my early symptoms came from that (nausea, fatigue, etc). Now that the radiation is finished and I'm only on the Yervoy/GM-CSF I mainly have midly loose stool (but no increase in frequency) while I'm on GM-CSF, then I go back to normal after the 14 days. I may have a slightly decreased appetite, but some of that may still be leftover from the radiation. I still eat the same foods I would eat without medication and my energy is really good (improving daily since the radiation). I have to do weekly blood tests to monitor kidney, liver, and hormone levels (one of the serious side effects that can happen include problems with hormone regulation) and have to be checked by my doctor once between treatments and then the day of the Yervoy infusion. 

If you read about Yervoy, side effects seem to vary a lot, but most tend to be with the GI tract (nasuea, diarrhea, etc) or skin (itchiness, rash, etc). Most are also fairly minimal and can be managed pretty well with anti- nasuea meds, anti-diarrheals, or other medications. There are some that are much more serious and I'm sure your doctors have discussed these with you/your father. There is a checklist of symptoms that they make me go through myself at least once a week and they go through every time they see me to make sure the symptoms aren't getting too bad. Mostly it's important if you decide to do this therapy or the trial to notify your doctor with any side effects you have so they can be managed or the treatment stopped if necessary. Don't forget that you can begin a therapy (or even a trial), but you don't have to complete it if the side effects are bothersome. With the immunotherapies it doesn't take long to recover after the medication is stopped. Also keep in mind that Yervoy is only 4 doses and will be completed in 3 months (although trials may have a different schedule) and it really doesn't have any lasting side effects aside from an "allergy" to CT contrast (I have to take a small dose of steroids before the CT scans). 

It's entirely up to you and your father what course of action is best for you and I wish you and your father all the best as you consider things and make your choice. I hope perhaps some of what I wrote is helpful.

-Eva

Hi,

I'm currently on Yervoy (labled dose, not the higher trial dose), but my doctor tacked on GM-CSF for 14 days after each infusion based on preliminary data from a trial like the one you're describing. The reason he added the GM-CSF was because the preliminary data showed that people on the combo (Yervoy plus GM-CSF) actually had fewer side effects compared to those just getting the Yervoy by itself. The data also indicated (though it's very early yet) that while it didn't make a person more likely to respond to therapy, for those that did respond the combo group seemed to have a longer lasting responses. Based on that, there didn't seem to be a down side- possibly fewer side effects and maybe a better/longer response so we added it to my therapy. It did take some convincing with the insurance company, but I'm currently on that combo.

Keeping in mind that I am on the lower labled dose, not the much higher dose typically used in recent trials, my side effects have really been pretty minimal. I also started WBR at the same time and I think many of my early symptoms came from that (nausea, fatigue, etc). Now that the radiation is finished and I'm only on the Yervoy/GM-CSF I mainly have midly loose stool (but no increase in frequency) while I'm on GM-CSF, then I go back to normal after the 14 days. I may have a slightly decreased appetite, but some of that may still be leftover from the radiation. I still eat the same foods I would eat without medication and my energy is really good (improving daily since the radiation). I have to do weekly blood tests to monitor kidney, liver, and hormone levels (one of the serious side effects that can happen include problems with hormone regulation) and have to be checked by my doctor once between treatments and then the day of the Yervoy infusion. 

If you read about Yervoy, side effects seem to vary a lot, but most tend to be with the GI tract (nasuea, diarrhea, etc) or skin (itchiness, rash, etc). Most are also fairly minimal and can be managed pretty well with anti- nasuea meds, anti-diarrheals, or other medications. There are some that are much more serious and I'm sure your doctors have discussed these with you/your father. There is a checklist of symptoms that they make me go through myself at least once a week and they go through every time they see me to make sure the symptoms aren't getting too bad. Mostly it's important if you decide to do this therapy or the trial to notify your doctor with any side effects you have so they can be managed or the treatment stopped if necessary. Don't forget that you can begin a therapy (or even a trial), but you don't have to complete it if the side effects are bothersome. With the immunotherapies it doesn't take long to recover after the medication is stopped. Also keep in mind that Yervoy is only 4 doses and will be completed in 3 months (although trials may have a different schedule) and it really doesn't have any lasting side effects aside from an "allergy" to CT contrast (I have to take a small dose of steroids before the CT scans). 

It's entirely up to you and your father what course of action is best for you and I wish you and your father all the best as you consider things and make your choice. I hope perhaps some of what I wrote is helpful.

-Eva

Hi,

I'm currently on Yervoy (labled dose, not the higher trial dose), but my doctor tacked on GM-CSF for 14 days after each infusion based on preliminary data from a trial like the one you're describing. The reason he added the GM-CSF was because the preliminary data showed that people on the combo (Yervoy plus GM-CSF) actually had fewer side effects compared to those just getting the Yervoy by itself. The data also indicated (though it's very early yet) that while it didn't make a person more likely to respond to therapy, for those that did respond the combo group seemed to have a longer lasting responses. Based on that, there didn't seem to be a down side- possibly fewer side effects and maybe a better/longer response so we added it to my therapy. It did take some convincing with the insurance company, but I'm currently on that combo.

Keeping in mind that I am on the lower labled dose, not the much higher dose typically used in recent trials, my side effects have really been pretty minimal. I also started WBR at the same time and I think many of my early symptoms came from that (nausea, fatigue, etc). Now that the radiation is finished and I'm only on the Yervoy/GM-CSF I mainly have midly loose stool (but no increase in frequency) while I'm on GM-CSF, then I go back to normal after the 14 days. I may have a slightly decreased appetite, but some of that may still be leftover from the radiation. I still eat the same foods I would eat without medication and my energy is really good (improving daily since the radiation). I have to do weekly blood tests to monitor kidney, liver, and hormone levels (one of the serious side effects that can happen include problems with hormone regulation) and have to be checked by my doctor once between treatments and then the day of the Yervoy infusion. 

If you read about Yervoy, side effects seem to vary a lot, but most tend to be with the GI tract (nasuea, diarrhea, etc) or skin (itchiness, rash, etc). Most are also fairly minimal and can be managed pretty well with anti- nasuea meds, anti-diarrheals, or other medications. There are some that are much more serious and I'm sure your doctors have discussed these with you/your father. There is a checklist of symptoms that they make me go through myself at least once a week and they go through every time they see me to make sure the symptoms aren't getting too bad. Mostly it's important if you decide to do this therapy or the trial to notify your doctor with any side effects you have so they can be managed or the treatment stopped if necessary. Don't forget that you can begin a therapy (or even a trial), but you don't have to complete it if the side effects are bothersome. With the immunotherapies it doesn't take long to recover after the medication is stopped. Also keep in mind that Yervoy is only 4 doses and will be completed in 3 months (although trials may have a different schedule) and it really doesn't have any lasting side effects aside from an "allergy" to CT contrast (I have to take a small dose of steroids before the CT scans). 

It's entirely up to you and your father what course of action is best for you and I wish you and your father all the best as you consider things and make your choice. I hope perhaps some of what I wrote is helpful.

-Eva

I'm glad I could be of some help to you. I did have another thought though- since you're looking at trials, have you and your father considered any of the PD-1 trials (alone or combo with Yervoy)? The PD1 drugs are showing great promise and typically with fewer side effects than Yervoy. There are some trials open now that are combining Yervoy with the PD-1 drigs which show even better responses than either drug by itself. I was looking into these trials myself but was disqualified due to the discovery of tumors in my brain (hence the radiation). So now I'm on the Yervoy + GM-CSF. I'm pretty happy that I was able to get the GM-CSF added as that seems to have some trial evidence (even if it's very early yet) that it may be beneficial. Perhaps it's worth thinking about (and asking your doctor about) PD-1 trials if you're considering clinical trials anyway?

It's a tough road for all of us, and bad news is always hard to take, but it sounds like your dad is in good health otherwise and is ready to fight. That will work in your favor regardless of the treatment plan you choose. I truely wish you both the very best and will be crossing my fingers that everything goes your way.

-Eva

Hi Lori,

My husband who became stage IV in Oct. 2010 (after 4 surgeries) has been on the Clinical Trial for Yervoy (10mg/kg) and the GM-CSF since March 2011.  He did the initial 4 doses in 12 weeks of the yervoy and has been on the maintenance schedule of every 12 weeks since.  We do the 14 days of GM-CSF shots and then 7 days off as well.  He had lesions in his liver (3) with the largest being 5 x 6, lungs (3), 1 unresectable on the back of his head putting pressure on his C1 – C2 cervical spine and (3) sub q's in this area as well.  He is now NED (no evidence of disease) for about 9 months now.  He has had small side effects and takes 7.5 mg prednisone a day as his body quit producing its own.  He does have some fatigue after infusions and some itching.  He used to get 1 ml. shots of GM-CSF and they had to lower it to 1/2 ml as he was having a  sore, swollen and an enlarged area around where they shots was given but since they decreased it to 1/2 he no longer has that.  We watched the sub q's shrink away to nothing and disappear.  You can read more in his profile if you are interested.  He also keeps a close watch on his Vitamin D3 levels and keeps them up in the 80-90 area since he has cancer and he credits this to helping him.  If you want any more information you can contact us.

Hope this helps, a good positive mental attitude (PMA) helps along with lots of prayers also receive credit for his now being NED.

Judy (loving wife of Gene Stage IV and now NED)

Hi Lori,

My husband who became stage IV in Oct. 2010 (after 4 surgeries) has been on the Clinical Trial for Yervoy (10mg/kg) and the GM-CSF since March 2011.  He did the initial 4 doses in 12 weeks of the yervoy and has been on the maintenance schedule of every 12 weeks since.  We do the 14 days of GM-CSF shots and then 7 days off as well.  He had lesions in his liver (3) with the largest being 5 x 6, lungs (3), 1 unresectable on the back of his head putting pressure on his C1 – C2 cervical spine and (3) sub q's in this area as well.  He is now NED (no evidence of disease) for about 9 months now.  He has had small side effects and takes 7.5 mg prednisone a day as his body quit producing its own.  He does have some fatigue after infusions and some itching.  He used to get 1 ml. shots of GM-CSF and they had to lower it to 1/2 ml as he was having a  sore, swollen and an enlarged area around where they shots was given but since they decreased it to 1/2 he no longer has that.  We watched the sub q's shrink away to nothing and disappear.  You can read more in his profile if you are interested.  He also keeps a close watch on his Vitamin D3 levels and keeps them up in the 80-90 area since he has cancer and he credits this to helping him.  If you want any more information you can contact us.

Hope this helps, a good positive mental attitude (PMA) helps along with lots of prayers also receive credit for his now being NED.

Judy (loving wife of Gene Stage IV and now NED)

Hi Lori,

My husband who became stage IV in Oct. 2010 (after 4 surgeries) has been on the Clinical Trial for Yervoy (10mg/kg) and the GM-CSF since March 2011.  He did the initial 4 doses in 12 weeks of the yervoy and has been on the maintenance schedule of every 12 weeks since.  We do the 14 days of GM-CSF shots and then 7 days off as well.  He had lesions in his liver (3) with the largest being 5 x 6, lungs (3), 1 unresectable on the back of his head putting pressure on his C1 – C2 cervical spine and (3) sub q's in this area as well.  He is now NED (no evidence of disease) for about 9 months now.  He has had small side effects and takes 7.5 mg prednisone a day as his body quit producing its own.  He does have some fatigue after infusions and some itching.  He used to get 1 ml. shots of GM-CSF and they had to lower it to 1/2 ml as he was having a  sore, swollen and an enlarged area around where they shots was given but since they decreased it to 1/2 he no longer has that.  We watched the sub q's shrink away to nothing and disappear.  You can read more in his profile if you are interested.  He also keeps a close watch on his Vitamin D3 levels and keeps them up in the 80-90 area since he has cancer and he credits this to helping him.  If you want any more information you can contact us.

Hope this helps, a good positive mental attitude (PMA) helps along with lots of prayers also receive credit for his now being NED.

Judy (loving wife of Gene Stage IV and now NED)

I'm sorry he was disqualified from the PD1 trials- it's frustrating to have your options limited (I know). I know many doctors are reluctant to add on things that are still in trials and not FDA approved, but mine never said anything about it being a risk of losing his license. I know he talked to 2 specialists at 2 different centers before he did it. Different states have different laws and I wouldn't begrudge any doctor holding back if their license is at risk. I have no idea how he got my insurance to approve it either since it's not an FDA approved combination, but trust me if insurance wasn't paying, I wouldn't be on it either. I know all insurance companies are different too, so maybe I just got lucky with ours. 

Melanoma is terrifying, especially when you're newly diagnosed and suddenly have so many decisions to make in a short period of time without (in many cases) much knowledge about the disease or the options for treatment. There's always so many things going through your head it makes it hard to think straight. This forum does seem to be a good place to get information, other's experiences, and support though. Even though it may feel like it sometimes, you're not alone. Whichever path you and your father take for treatment trust that it will be the right one and that it will work, but it's always good to have a backup plan with your doctors just in case. 

Wishing you all the best in your journey

-Eva

I'm glad I could be of some help to you. I did have another thought though- since you're looking at trials, have you and your father considered any of the PD-1 trials (alone or combo with Yervoy)? The PD1 drugs are showing great promise and typically with fewer side effects than Yervoy. There are some trials open now that are combining Yervoy with the PD-1 drigs which show even better responses than either drug by itself. I was looking into these trials myself but was disqualified due to the discovery of tumors in my brain (hence the radiation). So now I'm on the Yervoy + GM-CSF. I'm pretty happy that I was able to get the GM-CSF added as that seems to have some trial evidence (even if it's very early yet) that it may be beneficial. Perhaps it's worth thinking about (and asking your doctor about) PD-1 trials if you're considering clinical trials anyway?

It's a tough road for all of us, and bad news is always hard to take, but it sounds like your dad is in good health otherwise and is ready to fight. That will work in your favor regardless of the treatment plan you choose. I truely wish you both the very best and will be crossing my fingers that everything goes your way.

-Eva

I'm glad I could be of some help to you. I did have another thought though- since you're looking at trials, have you and your father considered any of the PD-1 trials (alone or combo with Yervoy)? The PD1 drugs are showing great promise and typically with fewer side effects than Yervoy. There are some trials open now that are combining Yervoy with the PD-1 drigs which show even better responses than either drug by itself. I was looking into these trials myself but was disqualified due to the discovery of tumors in my brain (hence the radiation). So now I'm on the Yervoy + GM-CSF. I'm pretty happy that I was able to get the GM-CSF added as that seems to have some trial evidence (even if it's very early yet) that it may be beneficial. Perhaps it's worth thinking about (and asking your doctor about) PD-1 trials if you're considering clinical trials anyway?

It's a tough road for all of us, and bad news is always hard to take, but it sounds like your dad is in good health otherwise and is ready to fight. That will work in your favor regardless of the treatment plan you choose. I truely wish you both the very best and will be crossing my fingers that everything goes your way.

-Eva

I'm sorry he was disqualified from the PD1 trials- it's frustrating to have your options limited (I know). I know many doctors are reluctant to add on things that are still in trials and not FDA approved, but mine never said anything about it being a risk of losing his license. I know he talked to 2 specialists at 2 different centers before he did it. Different states have different laws and I wouldn't begrudge any doctor holding back if their license is at risk. I have no idea how he got my insurance to approve it either since it's not an FDA approved combination, but trust me if insurance wasn't paying, I wouldn't be on it either. I know all insurance companies are different too, so maybe I just got lucky with ours. 

Melanoma is terrifying, especially when you're newly diagnosed and suddenly have so many decisions to make in a short period of time without (in many cases) much knowledge about the disease or the options for treatment. There's always so many things going through your head it makes it hard to think straight. This forum does seem to be a good place to get information, other's experiences, and support though. Even though it may feel like it sometimes, you're not alone. Whichever path you and your father take for treatment trust that it will be the right one and that it will work, but it's always good to have a backup plan with your doctors just in case. 

Wishing you all the best in your journey

-Eva

I'm sorry he was disqualified from the PD1 trials- it's frustrating to have your options limited (I know). I know many doctors are reluctant to add on things that are still in trials and not FDA approved, but mine never said anything about it being a risk of losing his license. I know he talked to 2 specialists at 2 different centers before he did it. Different states have different laws and I wouldn't begrudge any doctor holding back if their license is at risk. I have no idea how he got my insurance to approve it either since it's not an FDA approved combination, but trust me if insurance wasn't paying, I wouldn't be on it either. I know all insurance companies are different too, so maybe I just got lucky with ours. 

Melanoma is terrifying, especially when you're newly diagnosed and suddenly have so many decisions to make in a short period of time without (in many cases) much knowledge about the disease or the options for treatment. There's always so many things going through your head it makes it hard to think straight. This forum does seem to be a good place to get information, other's experiences, and support though. Even though it may feel like it sometimes, you're not alone. Whichever path you and your father take for treatment trust that it will be the right one and that it will work, but it's always good to have a backup plan with your doctors just in case. 

Wishing you all the best in your journey

-Eva