Clinical trial results
Learn more about the outcomes of trials that have been conducted at Macquarie University Clinical Trials Unit (CTU).
CHECKMATE-9ER (CA209-9ER)
A randomised, open-label trial in patients with previously untreated advanced RCC to receive either nivolumab in combination with cabozantinib or sunitinib.
The trial demonstrated a statistically significant improvement in progression-free survival (PFS), overall survival (OS) and confirmed overall response rate (ORR) for patients treated with nivolumab plus cabozantinib compared with those who received sunitinib.
Food and Drug Administration approved the combination of Nivolumab and Cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).
LITESPARK-022
LITESPARK-022 is a pivotal phase 3 trial of pembrolizumab plus belzutifan compared to pembrolizumab plus placebo for the adjuvant treatment of patients with clear cell RCC.
Results showed a statistically significant and clinically meaningful improvement in disease free survival (DFS) for pembrolizumab plus belzutifan compared with pembrolizumab plus placebo at the first interim analysis.
LITESPARK-022 is the first positive phase 3 in adjuvant RCC using a combination regimen versus an anti-PD1 ICI as a comparator.
MK-3475-B15 (KEYNOTE-B15 / EV-304)
MK-3475-B15 is a study to evaluate perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer.
Results showed that people who received these medicines were less likely to have their cancer come back and were more likely to live longer than those who had standard chemotherapy.
In some patients, no cancer was found at surgery after treatment. Most side effects were similar to those already known for these medicines. This treatment may become a new option for people with muscleinvasive bladder cancer.
C4391022 (FourLight-1)
C4391022 is a study of PF-07220060 Plus Fulvestrant Compared to standard treatment options in patients with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer whose disease progressed after prior CDK 4/6 Inhibitor-based therapy.
The study showed that when Atirmociclib was given with hormone therapy, the cancer stayed under control for longer compared with standard treatments. There was a lower chance of the cancer getting worse during the study period.
Most patients were able to tolerate the treatment, and side effects were generally manageable. These results suggest Atirmociclib may become a new future treatment option, but more studies are still needed.
GSK 222730
GSK 222730 is a study GSK5733584 in Subjects with Advanced Solid Tumors.
In this study, about six to seven out of 10 patients saw their cancer shrink in gynaecological cancers, which is encouraging for these hard‑to‑treat cancers.
Most side effects, such as nausea and low blood counts, were manageable and few patients had to stop treatment. More studies are planned, and the treatment is still being tested and is not yet routinely available.
MK-6482-012 / LITESPARK-012
MK-6482-012 is a study to assess whether adding the new medicines to the standard treatment of Pembrolizumab plus Lenvatinib could help people with advanced kidney cancer live longer or keep their cancer from getting worse.
The combinations assessed were Pembrolizumab in combination with Belzutifan and Lenvatinib, or Pembrolizumab and Quavonlimab in Combination With Lenvatinib.
The study showed that these new drug combinations did not help patients live longer or slow cancer growth compared with pembrolizumab plus lenvatinib alone.
DB-1311-O-1001
DB-1311-O-1001 is a first-in-human study of DB-1311/BNT324 (a novel B7H3 ADC) in patients with advanced solid tumors. It showed that DB 1311 could be given safely at certain doses and some patients had early signs that their cancer responded to treatment.
It had a manageable safety profile with low rates of G≥3 hematological events and promising antitumor activity, particularly in pts with advanced/metastatic SCLC.
While this medicine is still being studied and is not yet approved, the results help guide future research and may lead to new treatment options for patients in the future.
SHR-A1811
Safety, Efficacy and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2–Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2–Expressing or Mutated Advanced Solid Tumors.
The study showed that the treatment could be given safely at certain doses, with side effects that doctors were generally able to manage. Encouragingly, many patients – especially those with HER2 positive or HER2 low breast cancer – had their tumors shrink or stay under control.
Although SHR A1811 is still being studied and is not yet approved, these early results support further research and offer hope for new treatment options in the future.