The trial seeks to
determine whether targeted therapies for people whose tumors have specific gene
mutations will be effective regardless
of their cancer type. NCI-MATCH will incorporate more than 20 different study
drugs or drug combinations, each targeting a specific gene mutation, in order
to match each patient in the trial with a therapy that targets a molecular
abnormality in their tumor.
NCI-MATCH is a phase II trial with
numerous small substudies (arms) for each treatment being investigated. It will
open with approximately 10 substudies, moving to 20 or more within months.
The NCI-MATCH
trial has two enrollment steps. Each patient will initially enroll for
screening in which samples of their tumor will be removed (biopsied). The
samples will undergo DNA sequencing to detect genetic abnormalities that may be
driving tumor growth and might be targeted by one of a wide range of drugs
being studied. If a molecular abnormality is detected for which there is a
specific substudy available, to be accepted in NCI-MATCH patients will be
further evaluated to determine if they meet the specific eligibility
requirements within that arm. Once enrolled, patients will be treated with the
targeted drug regimen for as long as their tumor shrinks or remains stable.
Overall, trial investigators plan to screen about 3,000 patients during the
full course of the NCI-MATCH trial to enroll about 1,000 patients in the various
treatment arms.
Adults 18 years
of age and older with solid tumors or lymphomas that have advanced following at
least one line of standard systemic therapy, or with tumors for which there is
no standard treatment, will be eligible. Each arm of the trial will enroll up
to 35 patients. The trial’s design calls for at least a quarter of the
1,000-patients enrolled to involve people with rare types of cancer.
For several years now there has been much discussion of
using targeted therapies to treat cancer—this will be the first big study to
actually do it.
“NCI-MATCH is a unique,
ground-breaking trial,” said Doug Lowy, M.D., NCI acting director. "It is
the first study in oncology that incorporates all of the tenets of precision
medicine. There are no other cancer clinical trials of this size and scope that
truly bring the promise of targeted treatment to patients whose cancers have
specific genetic abnormalities. It holds the potential to transform cancer
care.”
Since many gene mutations in tumors
are infrequent or unique, screening for individual mutations is not
cost-effective or efficient in clinical trials. Instead, NCI-MATCH will use
advanced gene sequencing techniques to screen for many molecular abnormalities
at once. Large numbers of patient tumors will need to be screened because most
gene mutations occur in 10 percent or less of cancer patients. Most patients
are expected to have one, or at most two, treatable mutations in their tumors.
By having multiple treatments available for these genetic abnormalities in a
single clinical trial, several different study drugs or drug combinations can
be evaluated simultaneously.
The cancer treatment drugs being used
in NCI-MATCH include both U.S. Food and Drug Administration approved drugs as
well as investigational agents that are being contributed by a number of
pharmaceutical companies. Most of the arms in the trial will incorporate
single-agent drugs that are either commercially available or are still being
tested in clinical trials. However, a few arms will contain combinations of
drugs for which there are enough safety data and evidence that they might be
active against a particular genetic abnormality.
Screening has not started (starts in July 2015) and there is
no specific timeline. Participants will continue to take the trial drugs until
their cancer no longer responds to the medications. This approach may be the
template for future targeted treatments. Specific drugs for specific gene mutations is a step forward. Watch for results—sometime soon, I
hope.
Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
No comments:
Post a Comment