NCI Cinical trial – July -open to adults with solid tumors – MATCH

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  • #88433
    marions
    Moderator

    Protocol dictates biopsy:
    “Patients must have a tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. Biopsy must not be considered to be more than minimal risk to the patient. “

    Marion

    #88432
    marions
    Moderator

    Please speak with your doctor:

    The trial opened for enrollment in August 2015 with 10 arms.
    Each arm will enroll adults 18 years of age and older with advanced solid tumors and lymphomas that are no longer responding (or never responded) to standard therapy and have begun to grow.

    Note: see trial information here:
    https://clinicaltrials.gov/ct2/show/study/NCT02465060?show_locs=Y#contacts

    Note: patients may not need to travel far from home to enroll in the trial. Community Centers are involved as well. And, more centers will be added in the near future.

    The primary endpoint is the objective response rate, or ORR, defined as the percentage of patients whose tumors have a complete or partial response to treatment (that is, the tumors shrink by a certain amount).

    A secondary endpoint for the trial is six-month progression-free survival (PFS), that is, the percentage of patients whose disease does not worsen for at least six months.
    In addition to assessing ORR and PFS, researchers will also determine time to progression(TTP) of the cancer and evaluate the side effects of the treatments.

    A goal for NCI-MATCH is for at least 25 percent of the approximately 1,000 patients enrolled in the trial to have rare cancers.
    Note: this is great news for our cancer community.

    Investigators plan to obtain tumor biopsy specimens from as many as 3,000 patients initially. The specimens will undergo DNA sequencing to identify those that have genetic abnormalities that may respond to the targeted drugs selected for the trial.

    It has two enrollment steps. Each patient will initially enroll for screening.

    Note: the results of this part will be shared with the PATIENT and the treating physician. Everyone is in the loop.

    A biopsy procedure will be used to remove tumor samples.
    Note: I am investigating this, but it appears that regardless of a prior biopsy, tumor tissue will need to be retrieved again.

    This link explains in detail:
    http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match#4

    Hugs,
    Marion

    #88431
    marions
    Moderator

    NCI-MATCH Precision Medicine Cancer Trial Opens

    NCI-MATCH, the largest, most scientifically rigorous precision medicine trial in cancer to date, is now opening at cancer centers and community hospitals across the country.

    The trial, also known as trial EAY131, seeks to determine whether matching certain drugs or drug combinations to people whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type. Treatment for this trial focuses on molecular abnormalities of a patient’s tumor instead of the organ site of the cancer.

    The NCI-MATCH trial:

    Seeks to enroll adults 18 years of age and older with any type of solid tumor or lymphoma (cancer in the cells of the immune system) that has returned or worsened after standard systemic therapy (oral or intravenous). Patients may also be eligible if they have a rare type of cancer for which there is no standard treatment.
    Is a nationwide trial that is locally available and will enroll patients on a rolling basis as additional sites and treatment options become available (the trial opened with ten treatment arms and an additional 12 will be added within the next several months).
    Requires patients to have a new biopsy and their tumor cells will need to undergo genetic testing to see if they contain one of the gene mutations being studied. If so, they will receive additional evaluation to determine if they meet the specific eligibility requirements of the treatment arms to be accepted in the trial. Trial researchers expect that about 1000 patients—one third of those screened—will have one or more molecular abnormalities that match one of the 22 treatment options being studied
    NCI-MATCH was co-developed by the National Cancer Institute (NCI) and the ECOG-ACRIN Cancer Research Group, one of five NCI-sponsored National Clinical Trial Network Groups. ECOG-ACRIN is leading the trial.

    For more information or to locate trial sites, contact the NCI Cancer Information Service at 1-800-4-CANCER or visit the NCI-MATCH page on Cancer.gov.

    #88430
    marions
    Moderator

    dare….thanks for checking. This is a newly developed and to be implemented initiative, hence we can expect delays and some bumps along the road. I too will stay on top of this and share all new info as soon as I receive it.
    Hugs,
    Marion

    #88429
    dare
    Spectator

    Hey all, contacted NCI about this clinical trial and they said the start date has been pushed to late July. Unfortunately it seems like there isn’t a contact PI or even system in place for patient intake past the July 1st launch date.

    I’m sure there will be more developments in the next couple weeks and we’ll have more to go on.

    #88425
    marions
    Moderator

    As we are nearing the July 1 enrollment date for the NCI MATCH trial, I have requested further notification from the NCI in regards to patient participation in this important initiative.
    I will keep you posted on the developments.

    #88428
    marions
    Moderator
    #88427
    gavin
    Moderator

    Thanks for the extra info Marion, will put a link to this over on the FB page alongside the other info as well.

    Hugs,

    Gavin

    #88426
    marions
    Moderator

    A bit of an update on the MASH initiative:

    Today I spoke with an NCI representative regarding the steps patients can take for possible inclusion in the MASH clinical trial initiative.

    This study is not yet open for recruitment, as sites and locations of participating centers have not yet been released. Once sites have opened patients may be able to contact the principal investigator directly.

    We must await further notice.

    For the time being it is best to speak with your physician and see if this study is appropriate for you.
    http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match
    Or, contact NCI: 1800 422-6237

    #88424
    gavin
    Moderator

    Done Marion.

    #88423
    marions
    Moderator

    Of course, dear Gavin.

    #88422
    gavin
    Moderator

    Thanks for this Marion. Do you want me to link your post about this over on the FB page as well?

    Gavin

    #11343
    marions
    Moderator

    The National Cancer Institute (NCI) announced today a new precision medicine trial called NCI-MATCH (Molecular Analysis for Therapy Choice) that will be open for patient enrollment in July. The NCI-MATCH trial is the largest trial in the U.S. that will use precision medicine based on genetic screening of tumors.

    The trial explores treating patients based on the molecular profiles of their tumors regardless of their cancer type.
    The trial is for adults with solid tumors (including rare tumors) and lymphomas that no longer respond to standard treatment and have progressed on standard therapy.
    Patients will be “matched” by a specific abnormality in their tumors with a drug or drug combination that targets the specific mutation in the cancer.
    More than 20 treatments will be investigated in this Phase II trial. Ten small sub-studies (arms) will be open in July with 10 more arms opening soon after.
    Patients will be able to access the trial at up to 2,400 locations across the U.S. at sites that participate in NCI’s National Clinical Trials Network (NCTN).
    The study was co-developed by NCI, part of the National Institutes of Health, and the ECOG-ACRIN Cancer Research Group, part of the NCI-sponsored NCTN. It is being led by ECOG-ACRIN.

    For more information, contact NCI’s Cancer Information Service at 1-800-4-CANCER or visit http://www.cancer.gov.

    Watch Research Advocacy 101, a video resource developed to provide information about research advocacy at NCI!

    You will learn about the MATCH initiative with this link;
    http://dctd.cancer.gov/MajorInitiatives … dicine.htm
    http://deainfo.nci.nih.gov/advisory/nca … roshow.pdf

    The NCI-MATCH (“Molecular Analysis for Therapy Choice”) trial is led by ECOG-ACRIN with NCI and the National Clinical Trials Network. This trial will examine the molecular features of tumors in approximately 3,000 patients with solid tumors or lymphoma who have progressed on standard therapy, and hopes to match at least 1,000 of those patients to a treatment with a targeted drug or drug combination. Patients will need to have a biopsy, which will be used to screen for abnormalities in up to 200 genes known to be involved in cancer and/or to predict response to a particular drug or drug combination.

    Because any one molecular abnormality may be present in only 5-10% of patients with solid tumors or lymphomas, MATCH will have many “arms”, each with a drug treatment for a particular molecular abnormality or group of molecular abnormalities. Each targeted therapy will be studied in a single-arm phase II trial, with NCI-MATCH functioning as an umbrella protocol for these trials. Patients with a match to a drug treatment will stay on that drug treatment until their disease progresses (or the treatment becomes toxic), at which point they will, if they desire, undergo another biopsy to look for additional molecular features that could match them to a new targeted drug. Under certain circumstances (e.g., non-response with rapid progression), patients who have more than one “actionable” genetic abnormality will be able to match to a treatment addressing the second molecular abnormality without a repeat biopsy. Additionally, NCI-MATCH will compare pre-treatment biopsies to post-treatment biopsies to study why some tumors develop resistance to cancer treatment.

    Molecular tests to be performed on the tumors include genetic sequencing using a panel of about 200 genes (on the Ion Torrent PGM™ system), as well as other diagnostic assays for specific molecular features. Biopsies will be sent to a central laboratory at MD Anderson Cancer Center in Houston, TX. Four CLIA-certified laboratories will perform the tests — Frederick National Laboratory for Cancer Research, MD Anderson Cancer Center, Yale Cancer Center, and Massachusetts General Hospital.

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