Happy fall and welcome back to the Clinical Trial Conversations series! This month, Maia Walker, Lead Curator of the Fight CRC Trial Finder, and Manju George, Scientific Director at Paltown Development Foundation, interviewed Richard L. Schilsky, MD, FACP, FSCT, FASCO, Principal Investigator of the TAPUR clinical trial. 

TAPUR stands for Targeted Agent and Profiling Utilization Registry. We wanted to learn more about this trial that has been ongoing for about seven years and continues recruiting patients. 

Maia: Dr. Schilsky, let us begin by saying that it is an honor having you here to learn more about this multibasket trial you launched in 2016, the first clinical trial by ASCO. In simple words, please tell us what the TAPUR study is about. How is this different from other trials? 

Dr. Schilsky: The TAPUR Study is a clinical trial for people with late-stage cancer to study whether selected targeted therapies when matched to genomic alterations in a tumor can be effective for patients who no longer have standard treatment options available. Results will hopefully lead to increased personalized medicine options for more patients.  

The study is designed to be pragmatic, which means it is meant to be practical and to use tests and evaluations that are aligned with routine clinical care. For example, the study has broad eligibility criteria and allows patients with advanced and metastatic disease, collects the minimum necessary data (no additional data is collected only for research purposes), allows for flexibility including flexibility in treatment decisions, and has the option for study drug to be mailed directly to the participant homes (if oral drug). All drugs used on the TAPUR Study are provided from collaborating pharmaceutical companies at no cost to the participants. 

Manju: We know that the trial has an estimated enrollment of almost 3,000 participants, across 28 states, and has many arms and interventions. What arms of this trial might be pertinent for patients with colorectal cancer? 

Dr. Schilsky: Trial arms that are relevant to a specific patient depend on the genomic alterations detected in the patient’s tumor. There are several cohorts for patients with colorectal cancer that are currently enrolling, like the pembrolizumab cohort for POLE mutations. There are also other arms, for example, the abemaciclib cohort for colorectal cancers with a CDKN2A loss or mutation, and the nivolumab + ipilimumab cohort for colorectal cancers with a BRCA1/BRCA2 mutation. A list of open treatment arms in the study is also available on the TAPUR website at www.TAPUR.org.  

It is important to remember that study arms can close or suspend at frequent intervals, and that spots cannot be held for patients. 

Maia: What would you reply to a patient who asks, “My tumor does not have mutations in the genes for which targeted treatments are available, can I still get on the trial?” 

Dr. Schilsky: From the genomic report, your doctor will know if you have alterations that are a variant of unknown/uncertain significance (VUS) or an equivocal result. We have a Molecular Tumor Board that can review genomic results and assist in determining if a VUS/equivocal alteration can be targeted with a TAPUR study drug or if there are any other potential treatments or trials outside of TAPUR. 

Manju: How has this trial been helpful to the field, so far, for colorectal cancer, or other cancers? 

Dr. Schilsky: The TAPUR Study has reported findings from cohorts that have completed enrollment on whether a cohort has a positive result that warrants further study, or a negative result that did not result in effective control of disease. For example, the pertuzumab + trastuzumab cohort that targeted an ERBB2 amplification or overexpression in patients with colorectal cancer was found to show effectiveness in decreasing the size of the tumors. 

Pembrolizumab was effective in treating colorectal cancers with high tumor mutational burden, as was the combination of vemurafenib + cobimetinib for colorectal cancers with a BRAF_V600E/D/K/R mutation.  

In other cancers, pertuzumab + trastuzumab was effective in treating gallbladder and biliary tract cancers with ERBB2 amplification, and olaparib was effective in advanced pancreatic cancers with BRCA1/BRCA2 mutations. There are more TAPUR Study results for various tumor types, drug, and alteration cohorts available on the TAPUR Study website. 

Maia: Is there a particular time a patient should consider this trial?

Dr. Schilsky: Yes, the TAPUR Study can be considered once you are no longer benefitting from standard of care options, or when there are no standard of care options available. Your oncologist would determine if a TAPUR study drug may benefit you after reviewing the genomic profile results of your tumor. 

Manju: Is tumor genomic sequencing part of this trial or should a patient get it outside of trial? 

Dr. Schilsky: Genomic sequencing must be done prior to enrollment on the TAPUR Study. It’s acceptable to use genomic sequencing results that were obtained prior to screening. No new biopsy is needed, and any standard genomic profiling test is acceptable for the study. 

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. 

Dr. Schilsky, thank you so much for talking with us about this trial. We really appreciate it. 

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is currently recruiting participants to receive pembrolizumab (KEYTRUDA^®) that targets the POLE gene. You may want to talk with your oncologist about testing the tumor for gene abnormalities to determine if the tumor has an abnormal POLE gene.  

The TAPUR Study is an ongoing and enrolling clinical trial with over 250 clinical sites across 28 states conducted by the American Society of Clinical Oncology (ASCO). Talk to your oncologist about this clinical trial or locate a participating center near you at https://www.tapur.org/map. To learn more about the TAPUR Study, visit the TAPUR website, where a report of current treatment options on the TAPUR Study is also available. 

Stay Tuned for More! 

Once a month, Maia and Manju spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world! 

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials. 

Clinical trials are critical to finding a cure for colorectal cancer. As an advocacy organization dedicated to supporting and empowering a community of patients, caregivers and families, Fight CRC has partnered with COLONTOWN to deliver a monthly blog series highlighting everything patients need to know about clinical trials and the best treatment options available.  

In this series, we hope to cover promising trials that are enrolling, lessons learned from past research, logistics and resources to joining a clinical trial, and provide relevant and timely updates for our colon and rectal cancer community.

Be Sure to Check Out These Fight CRC Resources:

Clinical Trial Finder

• Colorectal Cancer Clinical Trial Finder
• Colorectal Cancer Clinical Trials Brochure  

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