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
* Subject to cohort availability. As of June 2018, enrollment of patients with multiple myeloma and non-Hodgkin lymphoma is suspended until further notice.
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 make a determination (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.