Craig Gedye & KEYPAD trial investigators - ANZUP 2019

In this ANZUP conference highlight, Craig Gedye chats to Carole Harris, Patti Bastik & Antoinette Fontela, the investigators for the KEYPAD trial. They chat about what it is like to be involved in a clinical trial for the doctor and the patients, the barriers faced to running a successful clinical trial, the KEYPAD study investigating the addition of immuno-oncology agents plus denosumab, and the techniques they have used to improve the success of their trials.

Craig Gedye is a physician/scientist, dual trained as a medical oncologist and basic science researcher. He works with patients with melanoma, brain, kidney, prostate, testis and bladder cancer at the Calvary Mater Newcastle, and is the Clinical Research Director at the NSW Statewide Biobank. He chairs the Renal Cancer Subcommittee for the ANZUP Cancer Trials Group, and undertakes translational cancer research at the Hunter Medical Research Institute, University of Newcastle.

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Talking Urology podcast transcript

ANZUP 2019 Interviews – Craig Gedye, Patti Bastick, Carole Harris & Antioinette Fontela

Craig Gedye: Good morning I’m Craig Gedye. I’m here with the team from St George Hospital in Kogarah – Patti Bastick, Carole Harris and Antoinette Fontela.

Antoinette: Hi.

Craig: How are you?

Antoinette: Good, thanks.

Craig: Thanks for your time this morning. We just wanted to start to talk about clinical trials and in particular Cooperative Group clinical trials in Australia and in particular ANZUP clinical trials. Where is St George Hospital?

Antoinette: It’s located in Sydney and it’s very close to the airport, so it’s along Botany Bay, beautiful area.

Craig: So, people parachute in?

Antoinette: Yes. Kite surfing more like, paddle boarding.

Craig: Okay. And Antoinette, what do you in the department?

Antoinette: I’m a clinical trial coordinator. I’ve been there for 16 years and specializing mainly in lung cancer but now renal cell cancer, so I’m very happy to be at ANZUP.

Craig: So, Carole, Patty what motivates you to do clinical trials? Why don’t you just do routine clinical practice?

Carole: Clinical trials gets a chance to get the latest treatments to patients, either new drugs that are coming available or repurposing old drugs in a new way and it gives patients more opportunities for more treatments.

Craig: Patti, what do you look for in a clinical trial when you’re selecting them for your patients?

Patti: The trials that have been more interesting would be those with drugs that we’ve seen proof of concept at conferences or have been very interesting in other tumor types that may be useful in what we’re treating now or new combinations that might allow patients access to drugs that we couldn’t get funded otherwise or a combination is usually used in that. But obviously we need to find trials where we know we can recruit to it, so we have the patient population who would be eligible for that trial.

Craig: So, there’s a lot of choice out there, a lot of trials and a lot of patients that need new opportunities. How do you manage those tensions within your team and who gets what trial and how do you work that out and how do you make sure that trials are available to patients?

Patti: I guess the first thing we look at is do we think it’s a trial that has our patient population and we can put patients on it and the next would be is it something we may already have a trial available in? So, we don’t want it to be a competing trial where already those patients might be on something or be eligible for trial already and that would then impact on the recruitment of each trial. We share the protocols around between our team. So, any time we are approached for a trial, we would send it to the other clinicians that treat that tumour type and discuss it with the Trials Unit to see if there’s capacity to take it or an interest to take on that trial.

Craig: And Carole, what do patients ask you about clinical trials? Do they that it’s an experiment but what are the questions they ask you?

Carole: I mean, if it’s a placebo control, they want to know whether they’re going to get the drug or not obviously. They want to know that that they’re not going to be disadvantaged and they want to know that actually properly they are going to be advantaged. The minimum treat that they’ll get is standard of care, but they’ll also potentially get something that adds value. I think one of the major advantages as well is they get the whole support, this very structured of bloods, scans and support from the trial nurses, so an extra level of support so that they get the best treatment possible.

Craig: And so, clinical trials take a lot of work. So, Antoinette, how do you overcome the barriers to clinical trials? How do you how do you make sure that the clinical trials that you get actually function well in your department?

Antoinette: I think it’s really important to have the investigators on our side and just really available and helping out if they’ve got questions. The trials are very time intensive so making sure that we don’t have a lot of competing trials and have enough time to dedicate to these trials and our patients.

Craig: It’s awesome. And so, one of the clinical trials that ANZUP has got with St George at the moment, in fact, St George is the top of the leaderboard for KEYPAD. It’s the Keypad study. So, Carole can you tell us about the KEYPAD study?

Carole: Sure. The Keypad study is a second line treatment in metastatic clear cell renal cancer that looks at Pembrolizumab plus Denosumab. We know that immunotherapy works in kidney cancer and Pembrolizumab is an immunotherapy agent and the question is, the addition of denosumab potentially can potentiate the immunotherapy effect of immunotherapy, so giving people an additional treatment, so not just immunotherapy available through the PBS but additional potential benefit of immunotherapy plus Denosumab.

Craig: So, there’s a lot of study. There’s a lot of sites around the country who are supporting us with this trial and we’re really grateful. You guys have had a little bit more success than others. Antoinette, is there anything you’re doing that’s really making the trials successful in your center?

Antoinette: Really good communication, I think. So, prescreening patients before clinic, we sort of meet in the corridors and have a chat about what patients might be eligible, attending the MDTs and trying to pick up patients that might otherwise be missed.

Craig: Patti, you’re not the investigator for the study. Carole is the investigator, so you’re supporting the study you’ve put your own patients— you’ve put your patients on the study, you’ve offered the study to these patients, how’s that experience of being the supporter?

Patti: Probably easier for me actually. Obviously, when you’re the principal investigator on a trial, you have to do all the paperwork and the legwork, whereas being the sub-investigator, I get to support Carole and trials that she’s chosen, but she gets to do the hard work. But it’s has not been a difficult trial to recruit to. I mean, as Carol said, we know that immunotherapy works in kidney cancer, so these patients are being offered the treatment. We already know it’s successful and they’re getting an additional treatment that might make the treatment better. I think good communication with Carole and I to keep up to date with what each other has available and flagging people in advance. So, a lot of talking to patients going, “If your next scan shows that something is worse, then I would think about this trial” so it’s not thrown oon them at the last minute.

Carole: To say, we’ve made a major effort to go through our clinic lists to see who’s potentially coming up and who’s available. And we’ve brought a clinical trial coordinator to our urological MDT to prescreen for patients as well for this and other trials.

Craig: And finally, a question for all of you. What do you think the experience that patients have on clinical trials? Is it generally a positive experience, not just the KEYPAD study, but for clinical trials in general? What’s your perception of how patients find being on a clinical trial?

Carole: I think patients actually enjoy the experience. They certainly get a better coordination of care. They like having someone like Antoinette to be at a call without having to hassle the doctors. I think they feel that they get better care, better supported, it is coordinated for them and they know that they are, a lot of times, accessing something new that may be actually be better than the standard of care.

Craig: Thanks guys. We’re really really grateful at ANZUP for all of the sites who are taking part in all of our studies and in particular, St George has been such a great supporter for our study, so thank you so much and thanks for time this morning.