ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study has expanded four cohorts for enrollment of additional participants and continues to grow, with more than 500 participants and 16 therapies now available.
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 wild-type 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.
- 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 2 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 are available, the TAPUR Study DSMB 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.
Learn more about the TAPUR Study at www.tapur.org. ■
© 2017. American Society of Clinical Oncology. All rights reserved.
