Who Is Eligible for TAPUR?
Patients who answer “yes” to all of the statements below may qualify for the TAPUR Study. The American Society of Clinical Oncology (ASCO), the TAPUR Study sponsor, recommends patients discuss the TAPUR Study with their doctor, or for more information, contact the TAPUR Study team.
- I am 12 years of age or older.*
- I am not currently pregnant and do not plan to become pregnant soon.
- I have an advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma.**
- My cancer is no longer responding to standard anti-cancer treatment or no standard treatment is available.
- I have had a genomic or molecular test performed on my tumor.
- I am out of bed and active at least half of each day (Providers: Patient ECOG Performance Status 0-2).
* Some restrictions apply. Not all TAPUR Study therapies are available for participants under 18 years of age. Contact a participating TAPUR Study clinical site or the TAPUR Study team using the “Contact Us” form below to learn about the eligibility age for a specific study drug.
**Subject to cohort availability. As of June 2018, enrollment of patients with multiple myeloma and non-Hodgkin lymphoma is suspended until further notice.
How It 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.
There are currently 22 drugs available through the TAPUR Study, for a total of 18 therapies. These therapies will be able to treat many of the common genomic targets for which drugs have been developed.
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.
Obtaining Genomic Profiling Tests
Scientists and clinicians are still working to understand which of the genomic variations play a critical role in cancer development. TAPUR will help clinicians and scientists understand which of the genomic variations can be successfully targeted with FDA-approved cancer drugs – so-called “actionable” genomic variants. Recently reported genomic profiling studies performed in patients with advanced cancer suggest that actionable genomic variants are found in 20-40% of patients’ tumors.
Your oncologist can help you find out if obtaining a genomic profiling test could be beneficial for your cancer care. Insurance coverage for a genomic profiling test varies, depending on your insurance plan. Your cancer care team and representatives of your insurance plan can help you understand the details of your plan and the coverage for the costs of the test. ASCO’s Cancer.Net website also includes a detailed guide for patients and families on Managing the Cost of Cancer Care. In addition, companies that perform genomic testing may offer assistance programs for paying for the tests. This information can typically be found on the test provider’s website.
The ASCO TAPUR Study team recognizes that cancer research advocates are important stakeholders and partners in clinical trials and can contribute to the planning and conduct of the TAPUR Study, as well as assist in increasing public and patient awareness. We welcome advocates to complete our brief online survey and sign up to receive communications and updates about the TAPUR Study and, for those interested, information on how to get involved.