› Forums › General Melanoma Community › CheckMate Phase 3 trial: treatment naive or not?
- This topic has 24 replies, 6 voices, and was last updated 10 years, 12 months ago by
Cooper.
- Post
-
- December 11, 2013 at 12:35 am
According to the "Top News Stories for 2013" thread, the hottest thing in melanoma treatment now is the combination of ipilumumab (anti-CTLA4) + Nivolumab (anti-PD1). The Phase 1 results reported by Wolchok et al at this year's ASCO meeting showed that more than 50% of the patients treated at the best dose experienced significant (>80%) tumor shrinkage which lasted more than a year (the end of the trial).
This summer, BMS began sponsoring a Phase 3 clinical trial called "Checkmate 067" ( NCT01844505 ) where patients will get ipi or nivolumab or both. Note that there is actually no "placebo" group or "interferon only" group or anything like that. Participants will get either the best available treatment (Yervoy) or the anti-PD1 or both. A win-win for patients. Also, this trial is open to Stage III unresectable as well as Stage IV patients.
This sounds like a great trial. I know that some of you are on it already and are experiencing great effects. What puzzles me, however, is that when I read the ClinicalTrials.gov write-up, it says that the inclusion criteria require "Treatment naïve patients". Then, in the next paragraph, the exclusion criteria include: "Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody".
So which is it? To get on this trial, do you have to be completely treatment naive? To me that means NO prior treatment– no radiation, no Zelboraf, no interferon– nothing. Or do you just have to be naive for anti-CTLA4 and anti-PD1?
(Note that a new termininology is starting to be introduced in the field. It appears that melanoma specialists are reserving the term "immunotherapy" to mean IL-2 and interferon. These new immune-based therapies (anti-CTLA4, anti-PD1, anti-PDL1, etc) are being called "checkpoint inhibitors"– hence the name of this clinical trial. I helps to keep up with the jargon.)
- Replies
-
-
- December 11, 2013 at 1:09 am
In my experience, questions on the further detailed qualification requirements for trials are answered via the trial center. Lots of things aren't listed here – specific blood levels for instance. Often clinicaltrials.gov is a little out of date. The trial center will have the correct requirements from the pharma company.
-
- December 11, 2013 at 1:09 am
In my experience, questions on the further detailed qualification requirements for trials are answered via the trial center. Lots of things aren't listed here – specific blood levels for instance. Often clinicaltrials.gov is a little out of date. The trial center will have the correct requirements from the pharma company.
-
- December 11, 2013 at 1:09 am
In my experience, questions on the further detailed qualification requirements for trials are answered via the trial center. Lots of things aren't listed here – specific blood levels for instance. Often clinicaltrials.gov is a little out of date. The trial center will have the correct requirements from the pharma company.
-
- December 11, 2013 at 3:10 am
Pat,
My trial is NCT01783938 which is a sequential trial of IPI and Nivo. The title is "Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)". I've been curious what the "CheckMate 064" means.
-
- December 12, 2013 at 3:53 am
For those of you interested: I posted a synopsis of "Safety and clinical activity of nivolumab in combination with ipi in patients with advanced melanoma" by Wolchok, Sznol, et al, as written for ASCO, on my blog June 1, 2013. There is a graph included with a breakdown of the results. At the bottom of a post on June 11, 2013, in "Random Gleanings" I note the concerns that have been relayed to me by folks at Moffitt on more than one occasion. While very promising, the side effects of this combo can be worrisome. Not as toxic as IL2, nor the life sentence that is melanoma untreated, but I think we have to be realistic about what the experts are saying and the data demonstrates. I wish all ratties embarking on this venture every success. Celeste
-
- December 12, 2013 at 3:53 am
For those of you interested: I posted a synopsis of "Safety and clinical activity of nivolumab in combination with ipi in patients with advanced melanoma" by Wolchok, Sznol, et al, as written for ASCO, on my blog June 1, 2013. There is a graph included with a breakdown of the results. At the bottom of a post on June 11, 2013, in "Random Gleanings" I note the concerns that have been relayed to me by folks at Moffitt on more than one occasion. While very promising, the side effects of this combo can be worrisome. Not as toxic as IL2, nor the life sentence that is melanoma untreated, but I think we have to be realistic about what the experts are saying and the data demonstrates. I wish all ratties embarking on this venture every success. Celeste
-
- December 12, 2013 at 3:53 am
For those of you interested: I posted a synopsis of "Safety and clinical activity of nivolumab in combination with ipi in patients with advanced melanoma" by Wolchok, Sznol, et al, as written for ASCO, on my blog June 1, 2013. There is a graph included with a breakdown of the results. At the bottom of a post on June 11, 2013, in "Random Gleanings" I note the concerns that have been relayed to me by folks at Moffitt on more than one occasion. While very promising, the side effects of this combo can be worrisome. Not as toxic as IL2, nor the life sentence that is melanoma untreated, but I think we have to be realistic about what the experts are saying and the data demonstrates. I wish all ratties embarking on this venture every success. Celeste
-
- December 11, 2013 at 3:10 am
Pat,
My trial is NCT01783938 which is a sequential trial of IPI and Nivo. The title is "Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)". I've been curious what the "CheckMate 064" means.
-
- December 11, 2013 at 3:10 am
Pat,
My trial is NCT01783938 which is a sequential trial of IPI and Nivo. The title is "Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)". I've been curious what the "CheckMate 064" means.
-
- December 12, 2013 at 10:11 am
Catherine Poole of the Melanoma International Foundation called BMS and got the answer to my question.The answer is that patients for this trial must be treatment naive.So to be elegible for the BMS Checkmate 067 (ipi or anti-PD1 or both) you have to be Stage IV or Stage III unresectable and have had NO prior treatments– no ipi, no Zelboraf, no interferon–nothing. I assume surgery or radiation is OK, but nothing systemic.I have no idea where they are going to find 916 patients who are completely treatment naive, but it's their ball so I guess we play by their rules.Thank you so much for looking into this for us, Catherine.-
- December 12, 2013 at 2:58 pm
Hi,
I'm in this trial, yesterday I received the first treatment. I was stage 3A until begining of November when scans showed 1.5 cm lung nodule and one hilar lymph node enlarged. I had VATS 3 weeks ago to remove the lung nodule with clean margins, mainly because they neeeded some tissue for the study and it could not get enough with a CT guided biopsy. The mid Novemver scans showed no other tumors, I had a CT scan for the thoracic region last week and that showed only the hilar node still enlarged and no other nodules. As far as treatment, I had lymph node dissection followed by 3 months of HD interferon in 2012, and this did not disqualify me from the trial. I don't know what treatment I received, I hope I got at least Nivo, if not the combination.
Hoping that the treatment it's working!
-
- December 12, 2013 at 2:58 pm
Hi,
I'm in this trial, yesterday I received the first treatment. I was stage 3A until begining of November when scans showed 1.5 cm lung nodule and one hilar lymph node enlarged. I had VATS 3 weeks ago to remove the lung nodule with clean margins, mainly because they neeeded some tissue for the study and it could not get enough with a CT guided biopsy. The mid Novemver scans showed no other tumors, I had a CT scan for the thoracic region last week and that showed only the hilar node still enlarged and no other nodules. As far as treatment, I had lymph node dissection followed by 3 months of HD interferon in 2012, and this did not disqualify me from the trial. I don't know what treatment I received, I hope I got at least Nivo, if not the combination.
Hoping that the treatment it's working!
-
- December 12, 2013 at 2:58 pm
Hi,
I'm in this trial, yesterday I received the first treatment. I was stage 3A until begining of November when scans showed 1.5 cm lung nodule and one hilar lymph node enlarged. I had VATS 3 weeks ago to remove the lung nodule with clean margins, mainly because they neeeded some tissue for the study and it could not get enough with a CT guided biopsy. The mid Novemver scans showed no other tumors, I had a CT scan for the thoracic region last week and that showed only the hilar node still enlarged and no other nodules. As far as treatment, I had lymph node dissection followed by 3 months of HD interferon in 2012, and this did not disqualify me from the trial. I don't know what treatment I received, I hope I got at least Nivo, if not the combination.
Hoping that the treatment it's working!
-
- December 12, 2013 at 4:32 pm
Hi, Sofistep-
Thank you for responding. I am delighted to hear that you are in this trial. Based on the Phase 1 results, it shows great promise and you are right to feel optimistic. As with all combo treatments, however, we have yet to know what happens with the side effects (remember, they had to cancel the Zelboraf + ipi combo trial early because of unexpected side effects). So please do keep us posted about how things go with you.
I'm getting really frustrated with the different things we are being told about elegibililty for this trial. This is important information for patients and it should not be guesswork. Your profile says that you being treated by Dr. Atkins at Georgetown. I wonder how he was able to get you into the trial. H-m-m-m. Looks like we need more info.
Thank again and good luck!
-
- December 12, 2013 at 4:32 pm
Hi, Sofistep-
Thank you for responding. I am delighted to hear that you are in this trial. Based on the Phase 1 results, it shows great promise and you are right to feel optimistic. As with all combo treatments, however, we have yet to know what happens with the side effects (remember, they had to cancel the Zelboraf + ipi combo trial early because of unexpected side effects). So please do keep us posted about how things go with you.
I'm getting really frustrated with the different things we are being told about elegibililty for this trial. This is important information for patients and it should not be guesswork. Your profile says that you being treated by Dr. Atkins at Georgetown. I wonder how he was able to get you into the trial. H-m-m-m. Looks like we need more info.
Thank again and good luck!
-
- December 12, 2013 at 5:08 pm
Maybe the fact that I did not receive any treatment in more than a year made the difference, or perhaps the fact that I did not finish the full year of interferon was taken into account, I do not know! . They considered me treatment naive, at least for the stage 4! I am also Braf negative if this matters! I also know that people enrolled in phase one and received interferon prior to enrollment were not disqualified either.
-
- December 12, 2013 at 5:08 pm
Maybe the fact that I did not receive any treatment in more than a year made the difference, or perhaps the fact that I did not finish the full year of interferon was taken into account, I do not know! . They considered me treatment naive, at least for the stage 4! I am also Braf negative if this matters! I also know that people enrolled in phase one and received interferon prior to enrollment were not disqualified either.
-
- December 12, 2013 at 5:08 pm
Maybe the fact that I did not receive any treatment in more than a year made the difference, or perhaps the fact that I did not finish the full year of interferon was taken into account, I do not know! . They considered me treatment naive, at least for the stage 4! I am also Braf negative if this matters! I also know that people enrolled in phase one and received interferon prior to enrollment were not disqualified either.
-
- December 12, 2013 at 4:32 pm
Hi, Sofistep-
Thank you for responding. I am delighted to hear that you are in this trial. Based on the Phase 1 results, it shows great promise and you are right to feel optimistic. As with all combo treatments, however, we have yet to know what happens with the side effects (remember, they had to cancel the Zelboraf + ipi combo trial early because of unexpected side effects). So please do keep us posted about how things go with you.
I'm getting really frustrated with the different things we are being told about elegibililty for this trial. This is important information for patients and it should not be guesswork. Your profile says that you being treated by Dr. Atkins at Georgetown. I wonder how he was able to get you into the trial. H-m-m-m. Looks like we need more info.
Thank again and good luck!
-
- December 12, 2013 at 10:11 am
Catherine Poole of the Melanoma International Foundation called BMS and got the answer to my question.The answer is that patients for this trial must be treatment naive.So to be elegible for the BMS Checkmate 067 (ipi or anti-PD1 or both) you have to be Stage IV or Stage III unresectable and have had NO prior treatments– no ipi, no Zelboraf, no interferon–nothing. I assume surgery or radiation is OK, but nothing systemic.I have no idea where they are going to find 916 patients who are completely treatment naive, but it's their ball so I guess we play by their rules.Thank you so much for looking into this for us, Catherine. -
- December 12, 2013 at 10:11 am
Catherine Poole of the Melanoma International Foundation called BMS and got the answer to my question.The answer is that patients for this trial must be treatment naive.So to be elegible for the BMS Checkmate 067 (ipi or anti-PD1 or both) you have to be Stage IV or Stage III unresectable and have had NO prior treatments– no ipi, no Zelboraf, no interferon–nothing. I assume surgery or radiation is OK, but nothing systemic.I have no idea where they are going to find 916 patients who are completely treatment naive, but it's their ball so I guess we play by their rules.Thank you so much for looking into this for us, Catherine.
-
- You must be logged in to reply to this topic.