John Donovan from Kildare is being treated for an advanced form of kidney cancer at Tallaght University Hospital (TUH). Since November 2021, he has been taking part in a trial for a new drug called Belzutifan which, he says, is “keeping me alive for the past two years.”

The retired grandfather has three grown-up children and seven grandchildren. He has just turned 70 and lives in Ballintore near Narraghmore in Co Kildare. Five years ago doctors discovered that he had advanced cancer in his one remaining kidney and on his lungs. Back in the 1990s, John had his other kidney removed after it stopped working. This cancer diagnosis came as an understandable blow to John who, for years, had been very active in local community groups and charities for which he’d won a Hero award in 2019.

Initially, when doctors discovered the cancer tumour on his one remaining kidney, it was decided not to operate, as some cancer spots had also been found in his lungs. Instead, he was treated at TUH with Sutent, a tablet that inhibits the growth of cancer. In 2019 his medication was changed to Nivolumab delivered by intravenous drip. This was a form of immunotherapy to help his immune system fight the disease.

Trial drug

In 2021 when this stopped working and his tumour began to grow again, John was asked if he would like to take part in a trial for a new drug called Belzutifan which fights cancer by blocking a key player in its growth process. It is described as a SACT (Systemic Anti-Cancer Therapy), a term that covers all anti-cancer drugs.

Over two years later, John has responded well to the trial drug which has been given in tablet form. He hopes to continue with the treatment in the future despite the fact that he recently had to reduce his dosage, due to some breathing problems. Trials for new drugs have very strict guidelines, and if side-effects are present that could be potentially related to the new drug, the dose is reduced. 

Heather Sloane, a Clinical Nurse Manager who has been caring for John, explains that this particular trial is “trying to find out how long Belzutifan can keep the disease from spreading or worsening. It’s already approved by the Federal Drugs Agency in the USA for kidney cancer. John is doing extremely well on this drug, with few side effects and his disease has been well-controlled thanks to this drug.”

Heather confirmed that John would not have had access to this drug in Ireland without being part of the Clinical Trial at TUH. Over 100 patients are currently taking part in Clinical Cancer Trials at the hospital, exploring new therapies for bladder, prostate, pancreatic and renal cancer.

Sandra's story

Sandra Whelan from Kiltipper in Dublin has also benefitted from taking part in a trial. Married with three grown-up children and five grandchildren, Sandra had worked in the Dropping Well Bar and Restaurant in Milltown for 20 years, right to when she was diagnosed with cancer in 2019. 

Sandra was admitted to Tallaght University Hospital via the Emergency Department on 19 December, 2019, after noticing that she had passed some blood. Initially, she wasn’t overly concerned and thought perhaps it was a kidney infection. However, after various tests and scans, doctors discovered two tumours on her kidneys.

On Christmas Day, 2019, after a CT scan, doctors told Sandra they had found an aggressive form of renal cancer. The first tumour on her left kidney was 10cm in length, while the second on her right kidney was 2cm. The Urology team, led by Surgeon and Urologist Mr Robert Flynn, decided that it was best to remove Sandra’s entire left kidney and she had that surgery just weeks later on 12 January.

In the meantime, doctors decided to continue with scans to monitor her right kidney. All went well until 2022 when the tumour on her kidney started to grow again and her medical team at TUH decided it was time to operate. This time, as Sandra had just one kidney, the surgeons only removed the tumour, involving a partial nephrectomy. After a five-hour surgery, Sandra explains that “a third of my kidney was removed and doctors felt I might need dialysis, but this hasn’t been necessary.”

In the weeks after this operation, Consultant Urologist Mr Arun Thomas, who had carried out this second surgery, told Sandra she might be a good candidate for a Cancer Drug Trial taking place at TUH. This would offer her the opportunity to have further treatment with drugs that inhibit the growth of any new cancer. Oncologists describe a drug trial like this as an “insurance policy.” The aim is to prevent the cancer from returning.

Sandra decided to take part in a double-blind, randomised trial to compare the effectiveness and safety of Belzutifan (a tablet taken each day) plus Pembrolizumab (given intravenously every six weeks) versus a placebo plus Pembrolizumab in the treatment of clear cell renal cancer. In this instance, the patients in this trial get Pembrolizumab, but they are not sure who gets Belzutifan or the placebo. 

Follow-up

Una Murtagh, a Clinical Nurse Manager who has been caring for Sandra outlines how “this study aims to compare disease-free survival for patients treated with Belzutifan plus Pembrolizumab versus the placebo plus Pembrolizumab. We want to see if this drug is superior. As well as comparing the safety and tolerability of these drugs, the trial is also looking at overall survival rate, so we follow up with patients for years.”

The Belzutifan/placebo was given in tablet form to Sandra. Recently the dosage was reduced after her haemoglobin count dropped and she experienced fatigue and “jelly legs.” If cancer patients have any side effects that could potentially be related to the trial drug, the dosage is reduced.

Una explains that “Sandra continues to be disease-free with no recurrence of cancer. This is definitely a positive outcome.  While there have been challenges along the way, the absence of cancer recurrence is indeed a significant milestone.” 

Sandra, who would not have had access to this drug in Ireland without being part of the Clinical Trial at TUH says it was “great to be selected for the drug trial and I feel very lucky to be part of it and to be getting further treatment. Everyone in the Cancer Clinical Trial Unit is just so good, right down to making sure you have a cup of tea while you are waiting for treatment. I can get in touch with them anytime, they have just been 100% behind me.”

Ashley Bazin, Team Leader on the Oncology/Haematology Clinical Trials at TUH says that “both Sandra and John’s stories are powerful examples of why Clinical Trials are so important for patients. Here at TUH we operate a patient-centred approach and strive to provide access to cutting-edge therapies, personalised care and comprehensive support to individuals affected by cancer. By collaborating with Cancer Trials Ireland and international partners, we aim to contribute to the global effort in finding effective and safe treatments, ultimately working towards a future where cancer is no longer a devastating disease.” 

Consultant Oncologist Prof Ray Mc Dermott, who is the principal investigator for this trial, outlines how “Clinical Trials are an essential component of cancer care as they help define the standard of care and offer access to the newest treatments for our patients. The mission of the Cancer Clinical Trials Team at Tallaght is to advance the field of cancer treatment by conducting innovative and impactful clinical trials. The dedicated team here are committed to improving patient outcomes and quality of life through the development and evaluation of novel cancer treatments.”

Sandra has almost completed her drug trial. As part of her follow-up, she will be regularly scanned to make sure the cancer has not returned. She reflects on how the Clinical Trials team are “amazing. They are always at the end of the phone and I know I can call the team if I am having any problems. They are at the top of their game.”

Sadly for John Donovan and his family, this wasn’t their first experience of cancer. He lost his adored wife Kay to the disease in 2016 after a brave 20-year battle with non-Hodgkin’s Lymphoma. John subsequently raised over €24,000 in Kay's honour for his local St Brigid’s Hospice on the Curragh.

Praising the staff in the Cancer Clinical Trials Unit, John acknowledges that “as well as caring for you, they are like a family - the staff in the unit are just wonderful."

"I feel 100% cared for by Heather, Ashley, Una and Dr Raheel and would recommend taking part in a drug trial to anyone who is offered the chance. We must find new cures for the future.”