Stuck between two trials…

This topic has 17 replies, 9 voices, and was last updated 7 years, 8 months ago by AZSoCal.

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- July 12, 2017 at 10:20 pm
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AZSoCal
Participant
I could use some help deciding between two trials:

The first is an open (non-binded) trial that is about to close. I would either get Ipi or Pembro at the standard dosage for each, although as I understand it, they will not tapper the Ipi if you have a negative reaction; they will just stop an monitor. Also, I have a 50 / 50 shot at either drug.

The other trial has 3 options, either a combo of Ipi and Nivo, or either of the drugs independently. I have a 40% chance at getting the combo, a 40% chance of getting just Nivo, or a 20% chance of getting Ipi.

The only problem is the 2nd study is blind. I won't know which I am getting, and b/c one of the options is a trial, I will have to spend a bunch of extra time getting placebo drugs based on the drug administration calendar (…about 15 extra infusion visits).

I'm torn…

– On the one hand, I'll know exactly what I'm getting, but have a lower chance of getting a (potentially) "better" drug — In this case Keytruda.

– On the other hand, I won't know what I'm getting, but I'll have a better chance of getting one of the "better" drugs (Nivo) and possibly even a combo (Nivo & Ipi).

There are toxicity concerns as well, obviously. But given that it's highly situational it's hard to really factor that into the decision, although the 10mg dosage of Yervoy scares me quite a bit (particuarly without the ability to taper).

Any thoughts or suggestions??

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- - July 13, 2017 at 12:57 am
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  Bubbles
  Participant
  It is hard to judge what you need given that we know nothing of your stage or prognostic factors. I presume you are Stage III. You don't mention it…and perhaps it is not present in either trial….but sometimes there are "cross-over" options for folks who are not responding, having trouble, or if the data starts looking better for one arm as compared to another. However, trials for Stage III patients may not have such an option. celeste
- - July 13, 2017 at 1:03 am
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  Elaine Block
  Participant
  We are in a similar quandry, complicated by the fact that my husband is probably allergic to prednisone — and steroids are used to deal with Yervoy side effects. One additional factor that weighs in favor of the open, 50/50 trial, is that if there are intolerable side effects, we'll know which therapy triggered the side effects. If we wind up in the combo arm of the other trial, we won't be able to be sure which triggered the side effects.
  - July 13, 2017 at 1:07 am
    
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    Bubbles
    Participant
    
    Ipi is the bad boy of side effects whether given alone or in combo with nivo. I wish you well. celeste
- - July 13, 2017 at 1:41 am
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  ed williams
  Participant
  I assume that this is for stage 3 and the choice of Ipi in the first trial is at 10mg/kg , my question would be is Ipi being offered at 10 or 3mg/kg in the second trial. You have a 2 out of 3 chance of getting a Pd-1 drug in the second trial vs 50% in the first trial. I have been part of checkmate 067 trial for the last 3 year so I am kind of biased towards the second trial. Last thought is that it is great to have choices!!!Best Wishes!!!Ed
  - July 13, 2017 at 2:46 am
    
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    AZSoCal
    Participant
    
    Sorry everyone!! Yes, I am stage IIIc and also still fairly young (41 year old male).
    
    I recently did some genetic testing on the tumor that was BRAF negative and PD-L1 negative. It also showed mutated biomarkers for CDKN2A and TP53, which I understand is a fairly aggressive prognosis.
    
    The official studies are:
    – SWOG 1404 (https://clinicaltrials.gov/ct2/show/NCT02506153)
    – BMS 951 (https://clinicaltrials.gov/ct2/show/NCT03068455?term=BMS+915&rank=1)
    
    Dosages for the 2nd study are…
    – Nivo (240mg) & Ipi (1mg)
    – Nivo (480mg)
    – Ipi (10mg) <– However, they are more open to tappering if I recact negatively
- - July 13, 2017 at 2:03 pm
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  HHN
  Participant
  Looks like they may be opening up Nivo for all Stage 3 patients and you won't have to do a clinical trial to get it. You don't want Ipi alone. Ask about the new FDA approval for Nivo and see if your doc can't argue for that.
  - July 13, 2017 at 5:27 pm
    
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    AZSoCal
    Participant
    
    Can you share a link to this approval for Nivo? Or anymore details?
    
    I've searched but cannot find anything. Thanks!
  - July 13, 2017 at 6:16 pm
    
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    ed williams
    Participant
    
    I think anon is jumping the gun a little bit,not that I would blame them based on the news from BMS!!!! https://news.bms.com/press-release/corporatefinancial-news/phase-3-study-evaluating%C2%A0-safety-and-efficacy-adjuvant-opdivo%C2%A0
  - July 13, 2017 at 6:21 pm
    
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    AZSoCal
    Participant
    
    Ah, thanks Ed!!
    
    Given what I outlined, would you still lean towards the 2nd trial?
    
    Appreciate you taking the time to reply. 🙂
  - July 13, 2017 at 7:54 pm
    
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    ed williams
    Participant
    
    Hi Azsocal, I try not to get into giving advice that is why I usually give links that feature Melanoma specialist. However on this one I do like the fact that you can get the combination with ipi being offered at 1mg/kg or Pd-1 monotherapy, on the down side would be ipi at 10mg/kg arm of trial. I would want to have a very experienced Oncologist based on increased risk of adverse events at this dosage!!! Best Wishes!!! Ed
  - July 13, 2017 at 8:55 pm
    
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    AZSoCal
    Participant
    
    Thansk again… totally appreciate the difficulties giving advice on such a complex topic with limited info. Just really looking to glean insights and see if my thinking aligns with people who have a bit more experience around these subjects.
  - July 13, 2017 at 9:19 pm
    
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    JaiLee
    Participant
    
    I started the first trial you mentioned, had 1 infusion of ipi, (3a) and had to quit because of nerve pain in my neck and right side of face. Just spread to left side of face and right arm. Severe headaches, sweating, chills. No idea if this is reversible, but my ast / alt also spiked and we decided not to continue. I really wish they had considered using a reasonable dose because I have read the lower doses are just as effective with significantly less side effects. So now I am left with wait and watch.
  - July 14, 2017 at 2:17 pm
    
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    Gene_S
    Participant
    
    My husbband took the Clinical Trial of IPI at 10mg/kg and GMCSF from Mar. 2011 until Dec. 2013 and he didn't have major side effects and he became NED in July 2012. He is the one that decided in 2013 to stop the drugs. So like everyone always says no 2 bodies are alike and therefore they don't all respond badly either. His worst side effect is his adrenal gland does not produce cortisol so he has taken 5 mg prednisone a day and your body produces that much itself.
    
    Judy (loving wife of Gene Stage IV in Oct. 2010 andd now NED for 5 years after starting a Clinical Trial in 2011)
- - July 13, 2017 at 10:21 pm
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  AZSoCal
  Participant
  Looks like the decision just got easier! 🙂
  
  They have removed the Ipi only ARM from the BMS study. It's still blind but either Nivo or Nivo & Ipi.
  
  Pretty big news!
  - July 15, 2017 at 1:02 am
    
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    Threefitty
    Participant
    
    Hi, Can you source that info. I just started BMS 915 (Dallas) and had not heard that.
    
    Much thanks.
  - July 17, 2017 at 8:46 am
    
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    Shade
    Participant
    
    I can corroborate that info regarding the BMS 915 trial. An email was received last Wednesday July 12th by one of the the Mayo Clinic research trial nurses from BMS. It read that those who were blinded into the ipi only arm will be unblinded and allowed to go on nivo. I don't know if they will be blinded between recieiving ipi with nivo or not (I suspect so).
    
    I spoke with the Mayo research nurse Friday afternoon July 14th.
    
    I'm not the original poster but was very pleased original poster bothered to reply with that info.
    
    It is not done yet. But apparently it will happen, they are working on it.
  - July 17, 2017 at 5:28 pm
    
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    AZSoCal
    Participant
    
    Sorry for the late reply. Didn't check this over the weekend.
    
    The other poster had the same info as me. It wasn't anything published, just a message that went out last week to those conducting the trial.
    
    I would assume your doctors should know by now, however. Odd that they wouldn't have told you directly, but perhaps they're still coordinating on messaging.