Kidney — In Follow-up

The commonest kind of advanced kidney cancer is called clear cell kidney cancer. Immune therapies have been shown to be effective in about a quarter of patients with advanced clear cell kidney cancer after the standard tablet treatment has failed. This study will test if a drug (denosumab) usually used to treat osteoporosis (thinning of the bones) or cancer that has spread to the bones, can be added to the immune therapy to increase the ability of the body’s immune system to attack kidney cancer cells. This study is designed to assess the effects and safety of the combination of two drugs; pembrolizumab and denosumab. All participants on the trial will receive both treatments. Blood and cancer samples will be collected from each patient to better understand who has benefited and who has been failed by the treatment combination.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Denosumab and Pembrolizumab in clear cell renal carcinoma: a phase II trial
Cancer Type
Trial Status
In Follow-up
Protocol Number
ANZUP 1601
Co-ordinating centre
Study Chair
Associate Professor Craig Gedye
Patient Population
Adults with unresectable or metastatic ccRCC progressing after treatment with a VEGFR TKI. Key eligibility criteria include target lesion(s) according to RECIST 1.1, good performance status (ECOG PS 0-2), no history of significant autoimmune disease, tumour sample available (archival or recent biopsy), and no previous treatment with immunotherapy.
Recruitment Target
70 participants
Detailed Information
Further Information
Participating Centres
Calvary Mater Newcastle
Concord Repatriation General Hospital
Northern Cancer Institute
St George Hospital - South Eastern Sydney Local Health District (SESLHD)
St Vincent’s Hospital Sydney
Border Medical Oncology Research Unit

Eastern Health
Monash Health Clayton
Ballarat Oncology and Haematology Services

ICON Cancer Care
Royal Brisbane & Women's Hospital
Sunshine Coast University Hospital
The Townsville Hospital

Flinders Medical Centre

Fiona Stanley Hospital