After Promising Initial Treatment Outcomes – TAPUR Study Enrollment Expanded

African American patient explaining issues to Asian doctor using tablet

The American Society of Clinical Oncology?s (ASCO) Targeted Agent and Profiling Utilization Registry also known as TAPUR-Study (ClinicalTrials: NCT 02693535) has expanded four cohorts for enrollment of additional participants and continues to grow with more than 500 participants and 16 therapies now available.

?This study just reached a key milestone and we?re excited to explore these treatments further,? said ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FASCO. ?While no conclusions about drug efficacy should be drawn at this point, we are very pleased with the growth and expansion of the TAPUR Study.?

Targeted therapies
The TAPUR Study is designed to identify signals of activity of commercially available, targeted anticancer drugs in advanced cancer patients whose tumor harbors one or more genomic variants known to be a drug target.

The TAPUR Study Data Safety and Monitoring Board (DSMB) has recommended enrollment of additional participants for the following cohorts:

  • Ovarian cancer patients with KRAS, NRAS and BRAF wildtype variants treated with cetuximab
  • Breast cancer patients with a high tumor mutation burden treated with pembrolizumab
  • Colorectal cancer patients with a BRAF_V600E mutation treated with vemurafenib plus cobimetinib
  • Non-small cell lung cancer patients with CDKN2A loss or mutation treated with palbociclib as monotherapy

Given this recommendation for expansion to Stage II, the TAPUR Study clinical trial sites will continue to enroll eligible patients in these cohorts.

The TAPUR Study DSMB has also recommended the permanent closure of the following cohort:

  • Pancreatic cancer patients with CDKN2A loss or mutation treated with palbociclib as monotherapy

Study design
TAPUR Study participants are enrolled into cohorts based on tumor type (advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma), genomic variant and study drug. Stage I enrolls up to 10 participants in a cohort and monitors for objective response or stable disease at 16 or more weeks. If two or more participants have successful outcomes, the cohort is expanded to Stage II, where an additional 18 participants are enrolled in the cohort and monitored.

A positive trial at Stage II requires objective response or at least 16 weeks of stable disease in at least 7 of 28 participants. While expansion of enrollment in a cohort indicates that sufficient drug activity has been observed in a small number of patients to warrant further study of the drug in that cohort, no conclusions should be drawn as to whether the drug will ultimately be shown to meet the protocol-specified definition of a positive trial. Once full data from Stage II is available, the TAPUR Study Data and Safety Monitoring Board will again review the data and determine if these criteria are met.

If fewer than two participants in a cohort have successful outcomes, the cohort is then closed. Closure of a cohort is an indication that there is lack of an efficacy signal in the drug-variant-disease cohort.

Currently, 510 participants are enrolled in the TAPUR Study, which is available at 83 clinical sites in 20 states. Bristol-Myers Squibb is now providing a new drug combination for the study, nivolumab + ipilimumab, an immunotherapy treatment that unleashes the patient?s immune system to attack their cancer. With this addition, there are a total of 19 drugs yielding 16 different targeted therapy options (some drugs are used in combination).


Last Editorial Review: November 16, 2017

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