Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid T

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Viewing 9 posts - 1 through 9 (of 9 total)
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  • January 7, 2016 at 11:39 pm #90788
    middlesister1
    Moderator

    Almost humorous that I’ve been following this for Mom and chance that Dad could be enrolled.

    Thanks Marion,
    Catherine

    January 7, 2016 at 5:39 pm #90787
    marions
    Moderator

    Finally received the answer:
    Merck requires sufficient tumor tissue for analyses of 25 slides. Archived tissue is acceptable.
    Hugs,
    Marion

    December 31, 2015 at 7:35 am #90786
    marions
    Moderator

    Catherine….
    as per exclusion criteria:
    Known additional malignancy within 2 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or in situ breast cancers.

    Inclusion criteria:
    Anal Carcinoma
    Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
    Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas
    Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
    Cervical Carcinoma
    Vulvar Carcinoma
    Small Cell Lung Carcinoma
    Mesothelioma
    Thyroid Carcinoma
    Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
    OR
    Any other advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H)

    And your Dad would have to have these alterations:
    PD1
    PDL1
    PD-1
    PD-L1

    Catherine, once primary tumor has been identified, you may still reach out to the investigator.

    Thinking of you,
    Hugs,
    Marion

    December 30, 2015 at 10:43 pm #90785
    middlesister1
    Moderator

    Marion,

    Quick question- do they exclude patients with mets to brain? Mom is still our small miracle, but Dad is in hospital and waiting for confirmation that the brain lesions found in an MRI yesterday are a secondary cancer (possibly lung). The first MRI yesterday said bleeding, but repeated with contrast and pretty sure we’re looking at 3 cancerous lesions on the brain. We are still numb from this news.

    Thanks,
    Catherine

    December 30, 2015 at 7:13 pm #90784
    gavin
    Moderator

    Thanks for that marion.

    December 30, 2015 at 12:29 am #90783
    marions
    Moderator

    A quick update re: tumor tissue sample, Merck representatives have been in touch with me and promised to have the answer within one week.
    Hugs,
    Marion

    December 16, 2015 at 8:57 pm #90782
    gavin
    Moderator

    Thanks for that Marion and I am sure that this info will be of great use to others.

    Hugs,

    Gavin

    December 16, 2015 at 3:27 am #90781
    marions
    Moderator

    Thanks, Gavin.

    Pembrolizumab (Keytruda, MK-3475 has been approved for melanoma, but can be prescribed off-label.

    This phase II study is opening January 16, plans to enroll 11 thousand solid tumor patients having reached maximum benefit from previous treatment and harboring these biomarkers: PD-1, PD-L1, PDL1, PD-1, PD-L1.

    Qualifying Extrahepatic and intrahepatic cholangiocarcinoma patients are included.

    It is noted that tumor tissue for study analyses must be supplied, but it is not clear whether this pertains to CCA patients as well. (I will try to get the answer and report back.)

    Study locations have not yet been released.

    December 15, 2015 at 6:43 pm #11940
    gavin
    Moderator

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

    https://clinicaltrials.gov/ct2/show/NCT02628067

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