The TAPUR protocol and consent form have been reviewed and approved by an Institutional Review Board.
In addition, ASCO has established three oversight groups—each of which will include patient representatives, investigators, and genomics specialists:
- Steering Group to oversee study operations, establish data sharing and publication policies, review plans to add or remove drugs from the study and approve participation of additional clinical study sites
- Molecular Tumor Board to review the proposed drug-target match and report to the clinician on potential treatment options on or off the study
- Data and Safety Monitoring Board to independently review study results to analyze and monitor for unexpected adverse events, to determine when enrollment of study cohorts should expand or cease, and to determine when to release data.
Determining Treatment Efficacy
The TAPUR Data and Safety Monitoring Board will review results and determine (according to standards in the protocol) whether a treatment is promising or not for a particular cancer and genomic variant. If a drug is determined to be ineffective for a particular cancer and genomic variant, the drug will no longer be offered in the study for that match, and ASCO will make this information public. If a drug is determined to be promising, ASCO will communicate the results to the drug manufacturer, which may decide to confirm the efficacy in another study. ASCO will also inform study stakeholders and release results from the study through peer-reviewed mechanisms.
Clinical Sites Interested in the TAPUR Study
Clinical sites interested in participating in the TAPUR Study are invited to complete our interested site questionnaire. Additional information regarding the timeline for site evaluation is provided on the questionnaire.
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
- Seattle Genetics
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.