Home Forums Melanoma Diagnosis: Stage IV Everything you want to know about the expanded access of PD1

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  • #63862
    PhillyRed
    Participant

    Thanks for adding to the discussion, Violeta – as you posted – “treated and stable” – these are key factors, that suggest the brain mets are not currently progressing – that can enable such patients to safely have access to the investigational drug, outside of the clinical trial. Because the pivotal Phase III safety data, which will heavily assist the FDA in determining whether to grant the anticipated approval for the drug to be marketed are not yet mature (they are still being accumulated and have not yet fully formally been evalauted by the FDA), cautions must still be maintained in treating patients with the investigational drug (even thoughthe EAP is technically not a Phase I or II study). Once the pivotal safety data are fully collected and evaluated and the toxicity profile is satisfactorily determined, it is likely that eligibility restrictions will be relaxed for the majority of patients with metatstatic disease, unless specific serious toxicities in particular organ systems become apparent, in which case certain prescribing precautions will be added for the approved drug.

    I was not suggesting that specific neurotoxicities have been observed for anti-PD1 drugs (I have no knowledge of this, and assume that there is no such toxicity, given the rate of the development of this anti-PD1 drug), but I was explaining why patients with active brain mets are almost always excluded in early phase clinical trials of oncology, as a considerable safety concern. I am very happy to hear about the EAP and feel that it is desperately needed!

    I fully understand the frustration of Stage IV patients trying to get into clinical trials, but when serious adverse events arise during a trial, especially if they are unexpected or have grave consequences, unless they can be confidently attributed to the investigational agent versus the underlying disease, the FDA will require much more safety data and evaluations, which in turn, can significantly delay the approval of a cancer drug, as well expose patients to additional risks of taking the drug if the toxicity profile is not sufficiently understood.

    #63863
    Celeste Morris
    Participant

    Be all that as it may… If you read the last article I referenced in my post…you will see that some mighty big dogs in melanoma research think excluding patients with brain mets from clinical trials needs to be reevaluated. Hopefully that will happen soon. Best to you all. C

    #63864
    Catherine Poole
    Keymaster

    I do think that things are changing regarding brain mets. In most trials, you stop the trial, do gamma knife radiation, and then proceed back onto the trial. Our treatments for brain mets have improved enormously and this may influence the outlook on impact on a trial. Truly, our trials need to be designed with the patient at the center of consideration. Our upcoming MICAB meeting in Brussells in honor of Patricia Garcia-Prieto will focus on this very subject next week. I hope to report back some compelling information. Thank you for this lively discussion though, Philly Red comes to us with extraordinary professional knowledge to be learned from.

    Violeta, I think you are in a wait and see situation, and the timing may be good for that by the time the EAP reaches Europe.

    #63865
    Linda G
    Participant

    Hi Catherine

    Yes it is Malignant mucosal melanoma of the maxillary sinus with metastases to the T6 spine area.

    #63866
    buffcody
    Participant

    How fortunate we on this forum are to have contributors with the knowledge of Celeste and Philly. Clear explanations backed by obvious extensive research. Many thanks to you and to all contributors.

    Frank

    #63867
    KarenJ
    Participant

    Just before last weekend, my husband started having numbness in his hand. I was concerned about a brain met, so I called his doctor’s office and they scheduled him for an MRI and found a pool of blood. Though the radiologist couldn’t see a tumor, the onc doctor concluded that there is a new bleeding microscopic met. Coincidentally, my husband blamed the numbness on the Androgel he was taking (ipi blew out his pituitary, so he has been on drugs to replace thyroid, cortisol, and testosterone), quit using it last Monday, and has had no symptoms since.

    The doctor discussed surgery followed by gamma knife. The neurosurgeon wants to do surgery, and it is scheduled for April 11. I guess he wants to get the blood out of there, but it seems extreme to go digging for a tumor they can’t see if they are going to do gamma knife anyway. Please comment. Is it typical to operate before gamma knife? He had a brain met that was treated with WBR because it was not operable and gamma knife would have caused swelling which would probably have caused paralysis on his right side.

    I am so glad there is a new program to provide this Anti-PD-1 drug to melanoma patients who, like my husband has failed ipi and now vemurafinib. I hope he is able to get it in time. My understanding is that he will have to wait 4 weeks post surgery before he can have the med. Another problem is that the cancer center here doesn’t have a Merck PD-1 trial, so my understanding is that it won’t be available for about 2 months. Is this correct?

    #63868
    Catherine Poole
    Keymaster

    The centers list has not been published. Most likely it will be at centers that are experienced with the drug. Otherwise doctors can go through the agency Merck hired for this project listed in previous posts.

    #63869
    artie
    Participant

    Does anyone know what dosage this EAP will be?

    #63870
    njreaders
    Participant

    any idea how long it takes Merck to approve a patient for early access?

    any idea on how long it takes Merck to get the drug to the doctor once a patient is approved?

    #63871
    Catherine Poole
    Keymaster

    I hope to know more next week. I am hearing 6-8 weeks before it sets up.

    #63872
    njreaders
    Participant

    I hope it’s not 6-8 weeks. for someone who is very sick, that is a long time.

    #63873
    PatW
    Participant

    KarenJ wrote:

    The neurosurgeon wants to do surgery, and it is scheduled for April 11. I guess he wants to get the blood out of there, but it seems extreme to go digging for a tumor they can’t see if they are going to do gamma knife anyway. Please comment. Is it typical to operate before gamma

    knife?

    Karen, our radiation oncologist said that radioactive beams get blocked or dampened down by water. “Water” includes blood or edema around a tumor. So it’s better to remove the tumor and the surrounding blood via neurosurgery and then go back and treat with SRS rather than start with SRS.

    #63874
    KarenJ
    Participant

    Thank you, Pat, for passing on that info. The water-radiation explanation doesn’t make sense to me from a physics perspective. Water is a good moderator of particle radiation, but doesn’t do much to gamma radiation. Higher density material is more of a moderator to gamma and x-rays. But maybe there is some undesired lensing, making it harder to focus the beam. I’m not trying to be argumentative, just trying to understand.

    #63875
    PatW
    Participant

    Karen, I know next to nothing about particle physics (or lensing, for that matter) so I can not be of any help. If you ever do get a satisfactory explanation of why blood and other fluids create problems with radiotherapy, please post it here. I would love to know.

    #63876
    njreaders
    Participant

    i’m so confused. My husband was seen by a doctor at one of the sites that will be giving the Merck 3475 but since he had a seizure the doctor says he’s not eligible. I’m trying to decide whether to do more whole brain radiation which the rad oncologist says has a less than 50% response rate and would late 1-2 months at most. He’d have to be taken by ambulance from either the hospital or the rehab place each day. But the doctor at the Merck site says if he ‘needs’ radation that means he’s not stable.The radiation is my idea to try to help him along til the Merck drug comes out. He sleeps most of the time either due to meds and/or the brain mets. He has to be fed and rarely talks. He first had whole brain radiation then yervoy which did not work. I’m trying to find someone within Merck who can get us the drug somehow. Does anyone have any ideas?

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