Pam Mangat Discusses ASCO's Plans to Address Challenges of TAPUR Trial

Researchers implementing the TAPUR trial have encountered some difficulties, particularly in filling the study cohorts, said Pam Mangat, MS, associate director TAPUR study at the American Society of Clinical Oncology (ASCO). However, the ASCO team is dedicated to forging ahead and addressing those challenges.

Transcript (slightly modified)

What challenges did ASCO face when implementing the TAPUR trial?

So challenges in implementing the TAPUR study, I would say because this is ASCO’s first clinical trial, building the infrastructure to be able to support and conduct a trial like this at ASCO was a bit of a challenge at first, but we’ve been able to do that. The team is very dedicated and ASCO is a wonderful organization, and really comes together to sort of help develop and run its programs, so we were able to overcome that one.

Another challenge in terms of the actual conduct and design of the trial would be the filling of the cohorts. So we have in our statistical design, we employ a Simon 2-stage design. Really what this means is that we are analyzing the data based on cohorts. The first stage where we take 10 patients who all—these are defined by patients with the same tumor type, study drug that’s being used to target a specific genomic variant, and the genomic variant would be part of that definition as well. So once we have at least 10 patients in a cohort and we would look at response data; if there’s at least 2 or more responses we would then expand the cohort to an additional 18, and this would be the second stage of that design, to 28 patients. If there are 7 or more responses, then that would identify that there is a signal.

Now, the challenge is that we have to identify participants to be able to fill certain cohorts. As it is right now, we have quite a few cohorts with only 1 patient in them. However, the study is still early so we’re not sure if it’ll just take time to fill these cohorts, or if we need to start thinking about whether or not we should collapse these cohorts at a certain point, just based on genomic variant and study drug irrespective of histology.

So it’s been a challenge thinking a little bit like that and trying to find a way to deal with these sorts of issues, but time will tell and we do have some plans in place to address those challenges.