The purpose of this study is to compare the safety and effectiveness of two new treatments: belzutifan alone or belzutifan in combination with pembrolizumab before kidney surgery and followed by a combination of belzutifan and pembrolizumab treatment post-surgery.
Belzutifan is a small molecule drug that specifically blocks a protein called Hypoxia-Inducible Factor 2 alpha (HIF-2α) and slows down or stops the growth of cancer. Belzutifan has been shown to provide better treatment results in kidney cancer compared to other drugs that target similar proteins to stop cancer growth.
Pembrolizumab is a type of medicine called an immunotherapy drug. It helps the immune system spot and attack kidney cancer cells by blocking a "stop sign" that the cancer uses to hide and help slow down or shrink the cancer.
The combined use of molecules similar to belzutifan and pembrolizumab has shown promising results in treating kidney cancer, although effectiveness depends on the specific combination. This treatment combination is experimental and is not approved to treat kidney cancer in Australia. This means that it must be tested to see if it is an effective treatment combination for kidney cancer prior to kidney surgery.
None
Presence of extensive tumour thrombus that necessitates early surgical intervention as per primary treating urologist.
cT1 or cT2a Gany.
Metastatic disease, or resected M1 disease.
Has received prior systemic therapy for ccRCC.
Parallel
Belzutifan
DrugBelzutifan orally at 120mg per day
Pembrolizumab
DrugIV pembrolizumab 400 mg on Day 1 of each cycle
Therapeutic effects of belzutifan with and without pembrolizumab on the proportion of viable tumour cells in the neoadjuvant setting
The proportion of viable tumour cells per patient post-neoadjuvant therapy as assessed by pathology
EFS rates between belzutifan with and without pembrolizumab neoadjuvant treatment plus adjuvant treatment arms.
Event-free survival after belzutifan with and without pembrolizumab in the neoadjuvant setting and adjuvant pembrolizumab plus belzutifan.
Pathological response rates between belzutifan with and without pembrolizumab neoadjuvant treatment
Pathological response rates between belzutifan with and without pembrolizumab neoadjuvant treatment
Safety of belzutifan with and without pembrolizumab in the neoadjuvant and adjuvant settings.
Occurrence of AEs graded according to Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5.0) after belzutifan with and without pembrolizumab in the neoadjuvant and adjuvant settings.
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This trial is not recruiting at the moment. You can still explore other options:
