How the TAPUR Study Works
- Treating physician reviews patient's genomic profile and determines that patient is eligible for TAPUR study. Patient makes informed decision to participate.
- Physician matches participant to an available study drug OR physician refers case to study Molecular Tumor Board in cases of the following:
- No protocol defined matches and potential clinical benefit (review required)
- Multiple drug matches (review optional)
- Desire for guidance (review optional).
- Physician and participant confirm choice of TAPUR Study drug (consistent with Molecular Tumor Board report, if applicable).
- A central TAPUR Study pharmacy provides the approved study drug at no cost to the trial participant.
- Patient data on standard toxicity and efficacy outcomes are collected for analysis.
The TAPUR Study is enrolling patients at clinical sites around the country. Review the statements below to determine if your patient may be eligible for the TAPUR Study. For detailed eligibility criteria and for a list of study drugs, refer to www.clinicaltrials.gov; NCT02693535, or contact the TAPUR Study team.
- Advanced cancer (including solid tumors, multiple myeloma, and B cell non-Hodgkin lymphoma)* with a genomic variant identified through a genomic profiling test that can be targeted with a study drug
- No longer benefiting from standard treatment, or no standard treatment available
- Healthy enough to participate (ECOG Performance Status 0-2)
- Must have measurable or evaluable disease
Once it is determined that the patient meets the defined trial criteria, his or her treating physician will select a drug from among those available in the TAPUR study protocol that targets the identified genomic variation in the patient’s tumor. If a relevant drug-target match is not described in the protocol, the physician may consult the Molecular Tumor Board which will review the clinical and genomic features of the case and identify potential treatment options on and off the study. All patients who receive treatment through TAPUR will be monitored for standard toxicity and efficacy outcomes including tumor response, progression-free and overall survival, as well as duration of treatment.
* Subject to cohort availability. As of June 2018, enrollment of patients with multiple myeloma and non-Hodgkin lymphoma is suspended until further notice.
Objective tumor response or stable disease at 16 weeks after treatment initiation are the primary study endpoints. The study will collect information on progression-free survival, overall survival, duration of treatment on study and treatment-related high grade and serious adverse events.
Collaborating Pharmaceutical Companies
ASCO acknowledges the following companies for their collaboration and support of the TAPUR Study:
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Eli Lilly and Company
For a list of available TAPUR Study drugs, see ClinicalTrials.gov: NCT02693535.
Companies interested in more information or participating in the TAPUR Study may contact the TAPUR team.
Genomic Testing Labs
Eligible patients must have an advanced cancer with a potentially actionable genomic alteration that can be targeted with a TAPUR Study drug. The study requires testing in a lab that is certified under federal requirements (the Clinical Laboratory Improvement Amendments, or CLIA), accredited by New York State (for laboratories offering services to residents of New York), and accredited by the College of American Pathologists.
In addition, the following labs have sought an ASCO designation that recognizes that they provide a test that is optimized for TAPUR Reporting:
- Caris Life Sciences®
- Foundation Medicine, Inc.
This designation is provided to laboratories that:
- Test for and report on at least 75% of the TAPUR genomic alterations*
- Creates reports that specifically identify the TAPUR Study genes, which can be sent to TAPUR Study clinical centers.
*If this condition is not met, additional restrictions apply.
Laboratories interested in obtaining this designation may contact the TAPUR team.
Disclaimer: Neither the American Society of Clinical Oncology, the TAPUR Study, nor any of their affiliates endorse, support, or oppose any particular product, service, organization, treatment option, or other matter. The mention of any product, service, organization, activity, or therapy on this website, or the designation of a laboratory’s reporting as being optimized for TAPUR reporting, should not be construed as an ASCO endorsement.