Home Forums Melanoma: Stage III Clinical Trial for Stage III Patients

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  • #21871
    Linny
    Participant

    These things don’t come around too often for Stage III folks, so if you’re newly diagnosed, you might want to ask your doctor about this one.

    A Study of the BRAF Inhibitor Dabrafenib in Combination With the MEK Inhibitor Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection. (COMBI-AD)

    This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

    http://clinicaltrials.gov/ct2/show/study/NCT01682083” class=”bbcode_url”>http://clinicaltrials.gov/ct2/show/study/NCT01682083

    #63810
    Catherine Poole
    Keymaster

    Thanks for posting. Slim pickings for stage III eh? I guess because many don’t have evidence of disease they put in the placebo and blinded parts. I hope we get something proven soon!

    #63811
    Linny
    Participant

    Yep. The pickings are slim, especially for those at IIIA. At least this is something to consider, though.

    #63812
    greenshaek
    Participant

    Hi there, after a recurrence I have been upgraded to Stage 3b and I’m very interested in this trial. I don’t, however, have any evidence of lymph node invasion, just local satellite metastasis. Does this disqualify me from the trial?

    #63813
    greenshaek
    Participant

    I’m really quite interested in this trial. Is anyone taking part? I’m not really up to date on everything and would like to know what the implications if this trial are. Are these drugs already on the market for stage 4? If I take them now, would I be excluding myself from future trials (of other drugs) .. Effectively burning my bridges unnecessarily? I don’t want to make a wrong decision and regret it in future. Any thoughts?

    #63814
    greenshaek
    Participant

    Still no one out there who’s on this combi trial? It looks like I might be starting it soon … not really sure if I’m doing the right thing!

    #63815
    Linny
    Participant

    I think the fact that there’s a placebo involved may be putting some people off. But that’s just a guess on my part. Or, perhaps these folks just aren’t forum members.

    You were probably given the same basic options that I was: Interferon, Observation Only, or Clinical Trial. Since you mentioned satellite metastases, your onc may also have given you a 4th offering.

    This was my reasoning behind my choice:

  • As tempting as Interferon was, I just didn’t want to deal with feeling sick for a year, not to mention doing self-injections. 😮

  • Observation Only meant a very aggressive schedule of scans and doctor visits. I think the first year it would have been every three months, the second year every four months, the third year every 6 months and I forget what it was after that. The kicker was that statistically this worked out to be about the same as taking interferon. WTH? :?

  • The only trial available to me at the time was one for a vaccine called MAGE. There was a placebo involved and participants had a 2/3 change of getting the vaccine. This also involved a very aggressive schedule of scans and doctor visits. 8-)

    I ended up choosing the trial because it offered me the best of all worlds.

  • An aggressive schedule of scans and doctor visits. The scrutiny with the trial was even a bit more aggressive because of the frequency of the injections. The first few shots were 3 weeks apart.

  • The potential of getting a drug with minimal side effects and no need to self-inject.

  • Even if I did end up getting the placebo, I would still have the aggressive schedule of scans and doctor visits.

    So for me, the trial was a win-win even with the placebo. I’ve finished the shots and am now under “Observation Only”. Unfortunately we learned a year ago that the trial did not meet its primary endpoint. :-( But they are continuing the trial in the hopes that it would meet a secondary endpoint. Do I regret my decision? HECK NO! :mrgreen:

    I suspect that this particular trial would have pretty much the same protocol involving frequent doctor visits and scans. They REALLY want to keep an eye on you when you’re in these trials and this is something to keep in the back of your mind when you’re making a decision.

    I’m very interesting in hearing about how this trial goes for you.

#63816
greenshaek
Participant

Thanks for your reply Linny. I do, however, see a huge difference between the trial you took part in and this trial.

I am really having a hard time deciding and would like to ask Catherine for help on this one. Catherine, what do you (or the board) think about the use of Dabrafenib/Trametinib as an adjuvant therapy? I’m really grasping at straws with this trial. It is all that is available to me (apart from interferon, which I refuse to take). I would do one of the immune therapy trials without a second thought, but playing around with genetic mutations whilst healthy?!? (And dealing with the side effects … oh dear!)

My dilemma is simply knowing that this might be my big chance … and I don’t want to miss it?

But a few things bother me – this trial has been running for so long (Since the beginning of 2013) and is still recruiting. Why is that?!? Is it because oncologists aren’t really convinced it’s a good thing?

Catherine, could you pass on these questions to your board? What are their opinions regarding the Combi AD trial? Thanks so much!

#63817
greenshaek
Participant

Hello everyone,

just a quick update: I’ve been participating in the Combi-AD trial (Dabfrafenib/Trametinib) for almost 4 weeks and I can definitely say that I didn’t land in the placebo arm. It’s been quite adventurous so far (to put it nicely!)

Side effects: chills, nausea, palpitations, weakness, fatigue, dizziness, a constant “burning” feeling in my chest, strange episodes with my heart where my arms/legs go all hot/cold/tingly and my heart beats too fast, general weakness and the feeling that my heart will give out with even the slightest physical exertion … but worst of all my neutrophils dropped down to below 0,5 after just 10 days on the drugs and I had to take neupogen shots + wear a mask because it shot my immune system to bits. Fun times!

I had a 10 day break and started again just 2 days ago on the reduced dosage (1/3 reduction). So far so good, just some chills and nausea but I can handle that!

As for my thought process – I’m still sceptical but it’s the only shot I have so I’m taking it. It may be good for nothing, it may even be detrimental, but there’s a slight chance that it might actually do good so why not give it a go?

I’m wondering if there are any other stage 3 patients doing the same trial?

#63818
Catherine Poole
Keymaster

I’m sorry I didn’t respond earlier, but for stage III trials there are no easy answers. Usually there is no evidence of disease to measure the effectiveness of the agent, so it has to be a long term trial to see if recurrence is prevented. We know from interferon, that recurrence happened sometimes quickly or was delayed by a year. I think the answers will evolve only after long term investigation. So I know that doesn’t answer your question, but if the side effects are miserable, you can leave the trial and know you gave it your best. I hope things do get better for you!

#63819
greenshaek
Participant

Just thought I’d update you all again …

Today I got booted. It’s over and I’m still in disbelief. I had two instances of Grade 3 Neutropenia and was always hovering just above the cut-off mark but this week I was just a few numbers below and that was it. Short and sweet, got the call today. No more dabrafenib/trametinib for me. I was actually tolerating it quite well (although some of the episodes I’ve had the past few days in the lead-up to me being kicked may point towards the contrary …)

So much for that. 😥 I’m rather disappointed to put it lightly. I managed just under 3 months (with two breaks). Probably not long enough to make a difference, but who knows.

*Rant Alert* Just another reminder that clinical trials aren’t about the patient, but rather about the company behind the drug doing their best to get the drug approved. I fully accept the fact that trial protocols are there for a reason, but outside of a clinical trial there would have been many other ways we could have dealt with the Neutropenia issue (for example taking the meds every second day or taking regular breaks to allow my bone marrow to recover, Neupogen shots etc. etc.) It’s just bitter to know that this may have been my chance … and now it’s gone. *Rant over*

Now a question (does anyone know the answer?) – Dabrafenib/Trametinib hasn’t been approved in Europe or Australia as a combination. I assume the combi is only accessible via clinical trials. I guess that means IF my melanoma progresses … I will only have access to the good ol’ Dabrafenib due to my previous involvement in this clinical trial. Please correct me if I’m wrong!

#63820
goldfidler
Participant

Sorry to hear about your removal from the trial. I can only imagine how disappointed you are right now. I can hear the frustration in your words.

I just wanted to say thank you for your post. For others (like me) who are going through other trials right now, it helps to hear about your situation. Sometimes it feels as though we are on an island, by ourselves, struggling to find answers to impossible questions. I hope it helps you a little to share your story because it helps all of us too.

Thank you and good luck on your journey. Stay strong.

#63821
Catherine Poole
Keymaster

Here is a list of trials that include stage IIIb in the inclusion criteria: http://www.amgentrials.com/amgen/studysearch.aspx?SearchStr=melanoma

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