ALEXANDRIA, Va. – The American Society of Clinical Oncology (ASCO) today announced it has begun recruiting patients with advanced cancer for its first-ever clinical trial, the Targeted Agent and Profiling Utilization Registry (TAPUR) study. The trial will evaluate molecularly-targeted cancer drugs and collect data on clinical outcomes to help learn additional uses of these drugs outside of indications already approved by the Food and Drug Administration (FDA). Patients enrolled in the study will have access to these cancer drugs at no cost.
The trial will initially enroll participants at 30 clinical sites located in Michigan, North Carolina, South Carolina, and Idaho and ASCO plans to expand to other areas of the country by the end of the year. Because of its unique design and purpose, TAPUR will include a broader patient population than in most clinical trials. Eligible participants include those who have an advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma who are no longer benefitting from standard anti-cancer treatments or for whom no acceptable standard treatment is available.
“This trial will help evaluate whether certain targeted therapies offer benefits when no established options remain and provide access to these therapies for patients who join,” said ASCO President Julie Vose, MD, MBA, FASCO. “With TAPUR, these patients have the potential to benefit from precision medicine strategies that have already demonstrated effectiveness in other selected cancer types. Like other clinical trial participants, they can also help tomorrow’s patients.”
ASCO encourages patients who are interested in TAPUR to speak with their doctors about how they can participate, or to contact the ASCO TAPUR team. Patients can find study information such as general eligibility criteria, participating locations and contact information for the study team at www.TAPUR.org. The TAPUR study is also registered on clinicaltrials.gov (NCT 02693535) which includes a full list of inclusion/exclusion criteria.
Innovative trial design offers flexibility for physicians and patients
TAPUR will enroll participants whose tumor has at least one genomic variant that is potentially targeted by one or more drugs available in the study. Physicians will select from a set of drugs that is defined in the study protocol or, if necessary, can consult a Molecular Tumor Board for information about possible treatment options. For each specific combination of tumor type, genetic variant and study drug, 10 participants will initially be enrolled. In groups where at least two participants respond to therapy, enrollment will expand by an additional 18 participants. Participants will be followed for standard toxicity and efficacy outcomes, and data on anti-tumor activity and toxicities will be collected for analysis and reviewed by an independent Data and Safety Monitoring Board.
ASCO will manage all aspects of the study. In addition to the Molecular Tumor Board and Data and Safety Monitoring Board, ASCO has established a Steering Group to oversee the trial. Patients and patient advocates are included in each of these groups and play a central role in providing direction and guidance regarding all aspects of the study. An Institutional Review Board has approved the study.
Leading companies and research networks partner to support trial
ASCO is launching the TAPUR study at clinical sites that comprise the Michigan Cancer Research Consortium, the Cancer Research Consortium of West Michigan, the University of Michigan, and the Carolinas HealthCare System's Levine Cancer Institute – experienced practices that run research trials for the National Cancer Institute and drug manufacturers.
Bristol-Myers Squibb, Eli Lilly and Company, Genentech and Pfizer have committed to provide marketed, targeted drugs at no cost to participants, as well as additional resources to support the TAPUR study. Additional companies are planning to participate after the study launch.
ASCO will use the Syapse Precision Medicine Platform to automate the study workflow including patient registration, eligibility assessment, matching of patients to therapies based on genomic data, drug ordering, data collection, and facilitating the Molecular Tumor Board process. Study drugs will be dispensed through Cardinal Health Specialty Pharmacy, and will be procured through direct integration with the Syapse TAPUR platform. Illumina’s NextBio Clinical and KnowledgeBase will support and inform case review by the Molecular Tumor Board.
ASCO will also collaborate with the Netherlands Center for Personalized Cancer Treatment, which is conducting a clinical trial using a study protocol very similar to TAPUR.
Founded in 1964, the American Society of Clinical Oncology (ASCO) is the world’s leading professional organization representing physicians who care for people with cancer. With nearly 40,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation, which funds ground-breaking research and programs that make a tangible difference in the lives of people with cancer. For ASCO information and resources, visit www.asco.org. Patient-oriented cancer information is available at www.cancer.net. Cancer-related policy developments can be found at ascoaction.asco.org.