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Stage 3c- clinical trial or standard of care?

Forums General Melanoma Community Stage 3c- clinical trial or standard of care?

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    s Mom
    Participant

      My daughter now has to decide on a clinical trial of Cavatak & Ipi or standard of care of Tveck(sp?).  Has anyone done this trial?  ANy suggestions?  She is 34.  

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        Bubbles
        Participant

          Hi Amanda's mom,

          I have done none of these treatments.  (I am a stage IV patient treated with opdivo years ago.) However, I have been watching and posting results of studies using intralesional therapy for melanoma for years.  I am certain they are going to play a big role in melanoma care in the future.  Here are probably more posts than you are interested in on t-vec:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/search?q=t-vec  

          Here are some on cavatak:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/search?q=cavatak+and+ipi  

          Now, the hard thing about trying to pull out what you need out of this is that the trials you would love to see happen rarely do!  For instance, I've been wishing they would do a head-to-head trial of all the intralesions. They haven't.  Additionally, when new things get started they usually start with folks who have already tried and failed therapies and are in bad shape.  Much of the early data is like that.  In your case….I am assuming your daughter has not had any prior therapy???  Plus, she is 3c???  We know that the folks with the least tumor burden and least prior treatment tend to do best.  So….as those drugs show good results in beat up Stage IV patients, they start trying them in other patients.

          Now all that said….I don't know where you are.  In the US, IPI alone or nivo alone are FDA approved treatments for Stage III patients.  Of those, nivo has the best percentage of responders.

          When you look at all the stuff about intralesionals as long as I have and read what the experts write about them….it is pretty clear they do best when combined with a systemic therapy like ipi or anti-PD-1 (Keytruda or Opdivo).  So if your choice is any intralesional alone vs an intralesional combined with immunotherapy….I would choose the later.  But, that's just me.

          I hope this helps rather than confuses.  Your daughter is lucky to have you in her corner.  Melanoma is not easy and treatment choices are written in a foreign language.  Hang in there.  Ask more questions as you need.  This board is full of knowledgeable caring peeps.  Look for threads by – texmelanomex.  He is currently on a trial with PV-10 (another intralesional) and Pembro (anti-PD-1/Keytruda).

          I wish you and your daughter my best.  Celeste

            s Mom
            Participant

              Thank you Celeste.  She was on Interferon for 7 months. It did not work.  She had additional tumors in her groin and surgery.  She has been on Keytruda (3rd dose yesterday) and it is not working.  She has multiple tumors in her groin and there are tumors within the tumors.  The trial they suggest is Cavatak.  I will read the links and thank you!

              Bubbles
              Participant

                Got 'cha!  I think intralesionals are a good option…esp when combined with immunotherapy.  The only other thing I would be talking to the docs about is the fact that immunotherapy takes time!!!  You have to be "patient with the patient"!  That's a quote from a web-a-nar two melanoma specialists gave.  

                The graphic included in this post says a lot:

                http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/02/time-to-responseipi-vs-nivo-and-ipi.html  

                It is looking at nivo and ipi/nivo patients…but we know response time is the same for folks on Keytruda.  Overall, median time to response is10-12 weeks.  However, there are well documented outliers who respond at 6-10 months out.  

                For whatever that is worth.  Were I in her shoes, if she is not having side effects to immunotherapy….I would push to being able to do both…immunotherapy and an intralesional.  But, clearly….nothing is simple in melanoma.  Hang in there.  I wish you both well.  Celeste

                Mark_DC
                Participant

                  Are you sure its cavatsk plus ipi rather than cavatsk plus pembro?

                  i agree with Celeste that three doses is probably too soon, i think its you need one or two scans to assess

                  i have been on pembro for fifteen months – it removed one tumour (took six months i think) but the other one has persisted and grew slightly. So three months ago i was switched to pembro plus tvec, somehow my insurance approved this (it rejected half way through by mistake) and this might be working. So i would want to combine the intralesional with pembro (or nivo). Ipi is a possibility but was too toxic for me.

                  am not an expert but am wondering why the propose intralesional when you have more than one tumour – would they inject all sites? You may not need to, if it has distant effects too, but am not sure of this.

                  good luck, Celeste’s advice is good!

                  mark

                  s Mom
                  Participant

                    We are in California.  She is being treated at City of Hope in Duarte with a Melanoma Specialist.  When she started the Keytruda she had a single mass about a 50 cent piece size.  That mass is like the size of an egg and she has about 10 more of different sizes in her groin and upper thigh area spreading to the backside.  Celeste, all the information you have provided is very interesting.  Thank you

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