Home Forums Melanoma Diagnosis: Stage IV "Washout" and Clinical Trials

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    Hi, I wanted to ask a few questions for those who are waiting for clinical trials, or this who have waited, or had the “washout” before starting clinical trials.

    I am currently waiting to start for the Anti-PD1 & Anti-KIR trial. I started washing out on Feb 28. The planning set date to start trial is April 1 this year. I was feeling pretty good starting earlier this month but now I’m noticing more tumors and much more growth. Not only that, I’m starting to feel weak, bad appetite, and can’t do much (swelling from a groin tumor in right leg). I can feel new subcutaneous tumors daily and have feel about 5 small spots on my scalp as well.

    I still have to pass my brain MRI next Monday which makes me very nervous. While I’m in this washout and, not being on medication, I’m just allowing the melanoma to grow fast! I’m not certain if this is the best method for me. I’m not bed bound and can still walk, etc, but again, the growth is visible.

    I was also on BRAF inhibitor for the last 14 months so I’m wondering if this is making the growth happening faster?

    Just curious if others are struggling with this same issue?

    To be honest, I thought I was going to be feeling better while off the medication, eating well, etc. But its been the actual opposite.




    Dear Shane ,

    I am so sorry to read about this, I fully recognize our own fight. Just wondering: why did you leave Braf inhibitors? Did you get resistance?

    We had very bad time as well. Sincerely for me was horror. In my opinion (edit: I am not a specialist) my sister was at high risk in the period of 28 days wash-out, but we had no choice. We wanted to go for Nivolumab, in order to have a chance for a stable response. She lives in Romania and exhausted already two new standard therapies (zelboraf and ipi). We also exhausted our financial resources, since for us no new treatment is financed by health insurance provider. Just before and in the wash-out period she was hospitalized in total 4 times for hypercalcemia (induced by tumor progress). In this period she was almost time bound to her bed home or at hospital Finally, she resisted and her blood analyses were still acceptable in the day of randomization. She entered in study and after the second infusion she began to stabilize very slowly. Her tumors are not shrinking yet but her general status improved and she can stay on her legs and even partly work.

    Wash out period + the period immunologic treatment it actually works are very long periods for somebody with fast progress. From my experience with my sister these can transform in real risks. It is something to decide for yourself and I know how hard it is to do it. Please ask a lot of questions to trials investigators. Try to see what is expecting for you after this wash out. How fast will work the combination? How many people respond and how many respond fast? Also speak with your own oncologist and try to monitor more often blood analyses (at least some significant indicators) and to keep informed the doctors from your trial. From our experience I know that in the day of first infusion your blood analyses has to correspond with their requirements, otherwise you will be delayed or -who knows- even considered not eligible.

    all my best wishes and warm thoughts for you


    Linda G

    I am fairly new to this with my husband just diagnosed with malignant mucosal melanoma with metastases to spine, but I just found something out that may help you. On Monday March 10, 2014 Merck announced an compassionate use, Expanded Approval Program for access to the MK-3475 drug, and Anti PD1 drug. . Here is the link and the announcement.


    MK-3475: U.S. Expanded Access Program Now Available, Other Countries to Start in 2014

    Published: March 10, 2014

    Message from Roger Perlmutter

    One of Merck’s top priorities is to accelerate the development of MK-3475 to bring this investigational medicine to as many patients who may benefit as we can, as soon as we can. Our first priority is always to ensure that we conduct the clinical trials that are required by the regulatory authorities and that answer important questions about the potential risks and benefits of our new medicines. These authorities need these answers in order to approve our medicines, and physicians need these answers in order to decide which medicines to choose for their patients. That is why enrollment in clinical trials is our priority; it’s why we encourage eligible patients to enroll; and it’s why we are very grateful to patients and investigators for their participation.

    Whenever possible, we also want to help in cases where diseases are immediately life-threatening and alternatives for treatment are either absent completely or have been exhausted. That’s why if one of our medicines has shown evidence of benefits outweighing risks in a potential indication; we are also committed to helping those with the relevant disease who are not eligible to participate in a clinical trial. We do this through our Expanded Access Programs (EAPs).

    Merck has initiated an Expanded Access program in the U.S. for MK-3475, our investigational anti-PD-1 immunotherapy. The program is available to eligible patients with advanced melanoma who have been previously treated with ipilimumab and, if indicated, a BRAF inhibitor. The program is now open in the United States, and we will be expanding to other countries this year.

    Expanded access programs are for patients who have serious or immediately life-threatening illnesses for which there are no other comparable or satisfactory therapeutic options. (See our public policy on access to our investigational medicines.)

    While clinical trials are always our first priority, because they are the best way to ensure broad access for patients who might benefit from our therapies – we initiated the MK-3475 advanced melanoma expanded access program to address an unmet medical need.

    We want to thank the many people throughout Merck who have enabled us to implement this program – as we continue to work toward the additional milestones ahead of us in our quest to bring MK-3475 to patients throughout the world. MK-3475 is being studied across a number of cancer types, and we will continue to share results with the medical community as they become available.

    If you receive a call or an email from a physician or patient regarding the MK-3475 Advanced Melanoma expanded access program, please refer them to our program partner, Idis, at:

    •In the U.S.: 1-855-478-4347 or via e-mail at mk3475us@idispharma.com

    •Outside of the U.S.: +44 (0)1932 824 123 or via email at mk3475row@idispharma.com.

    Idis will be maintaining a list of those who have inquired about the program, including individuals from countries where the program has yet to be initiated – so it is essential that all inquiries be routed to them.

    Thank you.

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