NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial

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  • #89503
    marions
    Moderator

    This trial is accessible in many locations. You should discuss interest in study with your physician. For those wanting to speak to the investigator at a particular trial site, please use this link, scroll down to Trial Contact Information

    Trial Lead Organizations / Sponsors / Collaborators:

    http://www.cancer.gov/about-cancer/treatment/clinical-trials/search/view?cdrid=773118#link/ContactInfo_CDR0000773118

    #89484
    patty-in-illinois
    Participant

    Well, two months ago (2- 28 day cycles) after taking the ECOGEAY 131 treatment arm P trial in the NCI MATCH Program. I just returned from MD Anderson from a scan and bloodwork. I had 6% shrinkage and stability. My bloodwork has not been affected by the trial, and it has actually improved every month!!
    Other than diarrhea, slight abdominal pain occasionally, and fatigue that just started in the last couple of days, I do not have any other ill effects from the trial.
    I am the first CC patient in this arm of the MATCH Program….and I am just skipping…skipping….skipping right along!!
    Actually looking forward to my next scan!!

    Side note: Arm P is for the Loss of P-TEN

    #89502
    marions
    Moderator

    Latest update on the trial our Patty is participating in.
    The NCI MATCH trial had build in an interim analyses. This is the officially released report.

    Executive Summary: Interim Analysis of the NCI-MATCH Trial

    Note: 24 cholangiocarcinoma patients had registered and 22 patients enrolled in this trial so far.
    Patty is in the new group. I hope she will be joined by many more.

    This trial is not predominantly conducted in major cancer centers, but rather 2/3 of the participating sites are found in community settings. This is great news for patients in outlying areas as travel time and cost is greatly reduced.

    National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) is a phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type. The trial was co-developed by the ECOG-ACRIN Cancer Research Group and the NCI.

    The trial opened in August 2015 with 10 treatment arms and a goal to genetically screen 3000 patients. Patient enrollment was paused in November 2015 for a planned interim analysis. Data as of March 9, 2016 were included in the analysis.

    Major Interim Analysis Findings

    The expectation was that the trial would genetically screen the tumor samples of about 50 patients per month during year one; however, enrollment far exceeded expectations with 795 people registering for screening in the first three months
    The laboratories were able to complete tumor testing for 87 percent of cases with samples submitted, a good result where the standard is about 80 percent
    Sample quality was the main issue for cases not able to be analyzed
    Nine percent of tested patients had a gene mutation matching one of the 10 available treatment arms, only one percent lower than the expected rate
    Most of the actual mutation prevalence rates found were much lower than expected based on estimates from The Cancer Genome Atlas and other sources
    Five percent of tested patients received treatment assignments (33) and 16 patients enrolled; 19 patients did not enroll in treatment for reasons including ineligibility, starting other treatment, disease progression, and death
    The following table summarizes accrual:
    NCI-MATCH Accrual Summary
    Activated 08/12/15; paused 11/11/15: 92 days
    Patient cases registered for screening 795
    Cases with samples submitted 739
    Cases where labs were able to complete tumor testing 645 87% (N=739)
    Cases with mutation matching 1 of 10 available treatment arms 56 9% (N=645)
    Patients matching specific eligibility criteria for, and assigned to, a treatment arm 33 5% (N=645)
    Patients who entered 7 of 10 available treatment arms 16 2.5% (N=645)
    Sixty-five percent of all patients who registered for screening had uncommon cancers—those other than breast, colorectal, non-small cell lung, or prostate
    One quarter of patient cases with samples submitted included optional cytology specimens, which proved to be valuable in 19 cases where the core samples were unusable but the cytology was able to be analyzed
    Changes to the Trial Based on the Interim Analysis

    The overall size of the trial is increasing from 3000 to 5000 patients for genetic screening, and to 24 available treatment arms
    The overall expected mutation match rate for 24 treatment arms is 23 percent
    Laboratory capacity has been expanded to handle processing of 100 patients per week
    Prevalence expectations for gene mutations have been revised downward based on actual findings
    There is a greater focus on communication with enrolling physicians about the importance of adhering to screening eligibility criteria and selecting patients with good ECOG performance status (zero or one), adequate organ function, and ability to withstand being off treatment for a month or more while testing occurs
    Cytology will be required in all cases
    Tumor samples obtained from patients up to six months prior to registration will be allowed
    Use of data from other genetic testing platforms at cancer centers and in industry will be pursued to identify patients for the treatment arms studying rare mutations
    Conclusions from the Interim Analysis

    A trial of therapy based on genetic characteristics of the tumor is feasible on a national scale in the NCI-sponsored networks
    The whole process of tumor characterization from accrual to biology read-out is feasible, having been accomplished in 87 percent of patients
    A high proportion of less common malignancies in this early analysis opens options for advances in these cancers
    The interim analysis that was applied early in the trial permitted implementation of several enhancements to the structure of the study
    The trial’s early analysis permits planning for the realistic needs of additional trials/drugs that can be analyzed in specific gene abnormalities

    #89499
    marions
    Moderator

    Officially released updated information can be found in this link:
    http://ecog-acrin.org/nci-match-eay131

    #89498
    marions
    Moderator

    Additional answers:
    Apparently less than 35% of biopsies resulted in targeted mutations with Pharma provided drugs.
    Perhaps this will change once additional trial arms are opened and is one of the reasons for halting this trial.
    Additionally, the bulk of referrals to this trial arrive from community oncologists and not from academic institutions which may or may offer competing trials to their patients.
    Please keep this in mind when speaking with your institutional physician and inquire about his/her thoughts regarding the MATCH trial.
    Your feedback is very much appreciated.

    Hugs
    Marion

    #89497
    marions
    Moderator

    Received latest update from the NCI Office of Advocacy Relations. Important information for patients and their physicians and the reasons for halting enrollment a bit longer than anticipated:

    “Dear Colleague,
    I want to let you know about an important decision that has been made in the NCI-MATCH / EAY131 trial. As you may know, the protocol design has a built-in review after 500 patients are screened, and to perform this review, we (ECOG-ACRIN and the NCI) paused the registration of new patients to the initial biopsy and genetic sequencing phase in November 2015. The size of the trial is 3,000 patients for the initial screening step, and since this study opened in August 2015, patient enrollment has quickly surpassed projections with nearly 800 patients registered for screening by the time the pause went into effect. Certainly, this situation is very different from the original estimates for this trial, which were based upon typical patient registration patterns in our therapeutic studies—modest numbers at the start of a trial that increase and gain momentum over time.
    The required interim analysis is well underway and a number of changes are being made to the trial at this time. We have determined that the pause on new patient enrollments needs to remain in place until all of these activities are complete. Therefore, the enrollment pause, originally expected to lift in January 2016, has been moved to April or May 2016.
    The changes being made to the trial are as follows:
    1. Expansion of laboratory capabilities. It is expected that the rapid pace of the trial will continue once new patient enrollment resumes. It is clear that an increase in laboratory capacity is required to accommodate the trial. We are currently adding staff in the specimen processing and qualification laboratory and upgrading the genetic sequencing technology.
    2. Opening of 12-14 additional treatment arms. We continue the process of adding new treatment arms to the trial and expect to have 22-24 arms open by April or May 2016. Pausing new patient enrollment until these arms open ensures that patients have the greatest opportunity to match to one of the treatments being studied.
    3. Scientific review of data from the first patient cases. Because the NCI-MATCH trial is the largest, most scientifically rigorous precision medicine cancer trial to date, we anticipated the need for scientific review early in the trial (after the first 500 patient cases). The purpose of the interim analysis is to:
    · Assess the diversity of cancer types (common and rare) among enrolled patients
    · Analyze the data on patients with a mutation that matches to one of the 10 available treatments versus those with no match
    · Estimate the proportion of patients who may have a mutation that matches to one of the 22-24 treatment arms, once all arms become available. The initial estimate was that one out of three screened patients would have a match once all treatment arms were in place. Recent literature data indicate that the percentage of patients that can be matched to a treatment may be lower. These types of data depend on the patients and tumor types in the trial as well as the treatments being studied. Data on the patients enrolled and screened to date in the NCI-MATCH trial will help refine this estimate.
    · Review the type and quality of initial biopsy specimens being submitted by the institutions enrolling patients in the trial
    · Assess the performance of the four laboratories supporting the trial to identify ways to improve or streamline processes
    · Evaluate the general performance of the institutions enrolling patients in the trial
    Patients who are currently being treated on one of the NCI-MATCH arms or who signed an informed consent document before November 4, 2015 will continue on the study with no changes in their participation according to protocol.
    Until the interim analysis is complete, we are not able to provide specific data or metrics on any aspects relating to the trial; however, we do plan to share the results of the interim analysis publicly upon completion of the activities described above.
    Thank you for your cooperation”

    #89496
    marions
    Moderator

    The MATCH protocol will share the findings of the screening test with each participant and should be safeguarded for possible future use.
    An assay validated as a test for molecular makers may be useful for off-label use or expanded access or for participation in the TAPUR Study. It may also benefit the generations to come. In the future, they may in fact discover that mutations are inheritable therefore; this type of information may be of value to family members.

    Marion

    #89495
    middlesister1
    Moderator

    This appears like it can be a tremendous opportunity for many- and it shows the importance of getting the genetic testing. Thanks Marion!

    #89494
    marions
    Moderator
    #89493
    gavin
    Moderator

    Thanks for that Marion.

    #89492
    marions
    Moderator

    Don’t think that anyone expected 500 patients registering for the MATCH trial for the first step of biopsy in only 4 months. Enrollment has been paused, as data must be evaluated. The next step is to evaluate the entire process that supports the study so that new treatment arms can be added as planned.

    In overview:
    · Effective on November 4, 2015 at 5:00 PM (EST), the NCI-MATCH trial will pause the registration of new patients to the initial biopsy and genetic sequencing phase, known as Screening Step 0. The trial is anticipated to resume new enrollments upon completion of the interim analysis, which is anticipated to be completed in January 2016.

    · For those patients who have already signed an informed consent form before November 4th, there will be no changes to their participation in the trial. Patients will be able to have their biopsy and receive their genetic sequencing results. If a patient’s mutation matches one of the drugs being tested in the open arms, the patient will be able to receive treatment on the corresponding arm.

    · Patients who are being treated on one of the NCI-MATCH arms will continue their treatment.

    · For physicians who are referring new patients for enrollment, there will be a pause at this time before any new patients can enroll. Physicians and patients can discuss other treatment options in the interim but may still be eligible to enroll in Screening Step 0 (the initial biopsy and genetic sequencing portion) of NCI-MATCH when the enrollment of new patients resumes.

    · Sites that are in the process of activating NCI-MATCH should continue with that effort.

    #89491
    marions
    Moderator

    What differentiates the TAPUR study from that of the NCI MATCH study?

    Answer: tissue sample.
    TAPUR accepts previously collected biopsy analysed by a certified lab
    MATCH requires a fresh biopsy

    2nd noticeable difference:
    MATCH is coordinating treatments with physicians in community centers affiliated with research programs. Please see map:
    http://ncorp.cancer.gov/findasite/map.html

    TAPUR – regardless of physician’s location or affiliation – they can request study participation for their patients
    ASCO will collaborate and share data with the Netherlands Center for Personalized Cancer Treatment, which is conducting a clinical trial using a very similar study protocol.

    TAPUR study is expected to launch January or February 2016
    MATCH has similar date.
    Both studies require: patients must have failed standard of care.

    Still to investigate: Is Gemcitabine/Cisplatin “standard of care” of is it “preferred care”?
    If so, then I would assume that patients can have failed on Gemzar or Gemcitabine only and still qualify for this trial. I will look into this.

    These companies are providing drugs (free of charge) to the patient via the prescribing physician:
    AstraZeneca
    Bristol-Myers Squibb
    Eli Lilly and Company
    Genentech
    Pfizer

    Noticeably absent is MERCK, but I have been told of ongoing negotiations between ASCO and Merck.

    The mutations addressed with available targeted drugs:

    Afatinib* EGFR activating mutations

    Afatinib* HER2 activating mutations

    Crizotinib ALK rearrangement

    AZD9291 EGFR T790M mutations and rare EGFR activating mutations

    Crizotinib ROS1 translocations

    Dabrafenib and trametinib BRAF V600E and V600K mutations

    Trametinib BRAF fusions or non-V600E, non-V600K BRAF mutations

    TDM1 HER2 amplification

    VS-6063 NF2 loss

    Sunitinib CKIT mutations

    Both, mutations and targeted drugs will continue to develop.
    Please discuss with physician.
    Marion

    #11632
    gavin
    Moderator

    NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial.

    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.

    http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match

    http://www.cancer.gov/about-nci/organization/oar

    Gavin

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