Home Forums Melanoma Diagnosis: Stage IV Clinical trial Ipilimumab + Nivolumab, any thoughts?

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  • #22176
    EvaSara
    Participant

    Does anyone have experience of this clinical trial? Opinions are also highly appreciated.

    http://clinicaltrials.gov/ct2/show/NCT01621490

    It looks like an efficient/toxic treatment plan: First Nivolumab and then move to the combination Ipi/Nivo if progression occurs and finally either Ipi, Nivo or combination of Ipi/Nivo.

    Prior Ipi is not a requirement, but I’m wondering if it would be best to get that first anyway since it is available in standard health care. I also don’t know if it is known if Nivo has long term effects in the same way as Ipi.

    #65447
    Catherine Poole
    Keymaster

    That is a very promising trial. Nivo (a Pd1) can have long term regression of disease. A study published in june found this combination to be promising, but as you point out pretty toxic. But, yes, this is a good trial and better than just going on IPI.

    #65448
    Celeste Morris
    Participant

    These combo trials are looking very promising and Dr. Weber addressed them specifically in a talk he gave in Paris in July of this year. (It is posted on the forum at Melanoma.org under the topic…Phase I Pembro and IDO inhibitors…if you are interested.)

    Here’s some basic info:

    Ipi alone has a 10-15% response rate with a 4 year survival of 37-49% and 10 year survival of 17-25%.

    Pembro and Nivo are both showing a roughly similar 40% response rate…depending on the study you look at. Obviously, their data is not as long term as that which is available for ipi…but 2 year survival (esp for Nivo as it has been studied longest) is ranging from 43-62%.

    When ipi and nivo are combined and given concurrently, response rates are 43% or better (some cohorts have demonstrated an 80% response rate) though dose limiting toxicities are a problem. A 2 year survival rate of 79% has been documented.

    It seems that most researchers feel that the combo is still worth it if the patient’s risk from disease is higher than the risk of side effects. Additionally, some trials are opening up that are “flipping the dose” and offering a higher dose of nivo (at 3 mg/kg) and a lower dose of ipi (at 1 mg/kg) as it is thought to be the main side effect inducer. More than that…and Dr. Weber addresses it in his talk…he and Dr. Hodi are running a trial in which nivo and ipi are given SEQUENTIALLY. So patients will take anti-PD1 then ipi, and others will take ipi first, followed by anti-PD1. It is hoped that with this regimen patients can still tolerate higher, more effective doses without suffering the side effects that can occur when the drugs are administered together.

    Hope that helps. Celeste

    #65449
    EvaSara
    Participant

    Thank you for your replies!

    Yes, I have understood that the combination is very efficient but also very toxic. That is why I thought that it could be a good idea to first try both Ipi and Nivo and if things are still going bad, it might be worth the risk to get the combination. There is also an extended access program for the combination (I think it is available in the USA) but the criteria say that no prior Ipi or anti PD1 is allowed so there is no chance to try the single drugs first.

    I’m also wondering about sequencing approaches. I think that I have seen somewhere that they are more efficient than a single drug. If a person first gets Ipi and then Nivo as soon as possible if the final scans show progress, wouldn’t it basically be a sequencing approach?

    It is so good that there are some treatment options for this disease!

    #65450

    My husband who was just diagnosed at Stage IV and we asked about the study of Ipi and Nivo..shown above…and were told they were not accepting new patients even though all of the clinical listings show that they are. We were given the ipi option at Dana Farber and another trial…not the ipi/nivo trial nor any trials with a PD1. Question is this: Do we trust the doctors when they say the trial is not available to us even if other documentation is saying otherwise? Is it worth it to go to NYC to Sloan Kettering and see what they have available? I am thinking “yes”. He has not yet done Yervoy but we didn’t think that was a prequisite for some of the ipi/PD1 trials. Anyone have thoughts on this? Thank you!

    #65451
    MathewR
    Participant

    I often tell people that planning treatments is like a decision tree–you go down one path and it forecloses other options. By choosing to be treated with ipi, you will foreclose certain trial options. It doesn’t mean that you shouldn’t do it, but just be aware of that fact. As for second opinions, I’m in favor of them. Dana Farber is obviously an excellent institution and the doctors there will be aware of the high profile trials. That said, I think that each doctor/institution tends to focus on what they are doing and not so much on what the “other guy” is doing. If you have the ability to do it, I would see Wolchok at Sloan, Weber at Moffitt or one of the other melanoma “rock stars”.

    #65452
    kylez
    Participant

    jawillett, I found the most useful parts of clinicaltrials.gov are the list of trials itself, and the locations/contact #s inside each trial entry. I spent a lot of time dialing phone #s, either the contact # listed, or if no # listed, going to the facility’s web site and looking for the clinical trail coordinator’s phone #(s) directly on the facility web site. Some facilities make it hard to reach the trial coordinator others are great.

    The information from the trial coordinators (often they are research nurses), was the real deal. For sure they know if their own site has slots. I don’t know that the trial coordinator at site A necessarily knows the status of the same trial at sites B, C, D, but they probably do if the status is trial-wide. They also may know the status of the cohorts, i.e., this cohort is closed, but the next cohort is expected to open in 3 weeks, say. My own facility didn’t have anything they recommended for me at the time, so I was looking at other facilities. I was able to get into a trial using this strategy.

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