On June 6, ASCO announced that Bayer and Merck are the most recent companies to sign on to provide study drugs at no cost to patients enrolled in the Targeted Agent and Profiling Utilization Registry (TAPUR) study, joining six other companies in ASCO’s first-ever clinical trial. Since opening on March 14, 2016, 18 participants have enrolled and are receiving study treatment, and 31 more have provided consent and are in, or have completed, the screening process. These numbers continue to grow daily.
TAPUR is designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the Food and Drug Administration. TAPUR is currently underway at 37 clinical sites with additional sites to be added in the coming months. Nearly 100 clinical sites around the country have expressed interest in participating in the study.
“TAPUR addresses a critical priority for achieving the promise of precision medicine: identifying existing, effective treatments for cancers based on their genomic profiles,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FASCO. “Since only about five percent of adult patients participate in oncology clinical trials, creative approaches like TAPUR, whose study design is grounded in real-world clinical practice, are needed to gather information that will benefit future patients.”
The TAPUR study provides substantial flexibility and opportunity for both patients and clinical sites to participate by:
- Allowing physicians to choose the tumor specimen/blood sample and genomic profiling test
- Using broad general eligibility criteria, rather than the restrictive criteria applied in most trials
- Streamlining data collection and reducing the overall amount of data collected, in comparison to most trials.
In addition to Bayer and Merck, there are six other pharmaceutical companies currently participating—Astellas, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, and Pfizer—that, among them, will provide 17 drugs that yield 15 different targeted therapy options (some of the drugs are used in combination with one another) for participants with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma. ASCO has designed the trial to facilitate including additional drugs and companies as the trial continues.
ASCO is using the Syapse Precision Medicine Platform to automate the study workflow, including patient registration, eligibility assessment, providing TAPUR study drug options based on genomic data, drug ordering, data collection, and facilitation of the study’s Molecular Tumor Board review process. Study drugs are dispensed through Cardinal Health Specialty Pharmacy and procured through direct integration with the Syapse-TAPUR application. Illumina’s BaseSpace Cohort Analyzer and KnowledgeBase (previously known as NextBio Clinical and KnowledgeBase) are used to support and inform case review by the Molecular Tumor Board.
ASCO is working with the Research Advocacy Network (RAN) to conduct an important TAPUR sub-study that will provide insights to help the oncology community understand how tumor genomic testing is being used by clinical oncologists, and how to provide assistance with provider and patient education. The sub-study consists of two brief surveys administered to TAPUR physicians at time-points before and after TAPUR participation.
ASCO also will collaborate with the Netherlands Center for Personalized Cancer Treatment, which is conducting The Drug Rediscovery Protocol (DRUP) trial, a protocol very similar to TAPUR which allows data sharing.
The TAPUR study also is registered on ClinicalTrials.gov (NCT 02693535), which includes a full list of inclusion/exclusion criteria and other information. Patients can find study information such as general eligibility criteria, participating clinical sites, and contact information for the study team at www.TAPUR.org. Researchers and practices interested in participating can fill out the TAPUR Study Site Questionnaire or contact study organizers at: http://www.tapur.org/contact-us.
To watch a video that provides an overview of the TAPUR study, go to: https://www.youtube.com/watch?v=ALdODwWDtCY or click on the video below.