Kidney — In Follow-up

Renal cell carcinoma (RCC) is the 7th most diagnosed cancer in Australia and the 14th most common cancer in Western populations. Approximately 90% of kidney cancers are renal cell carcinomas (RCC). At the moment the five-year survival rate for Australians diagnosed with kidney cancer is 78.5%, although most people with kidney cancer localised only to the kidney can be cured. Immune therapies have been shown to be effective in about a quarter of patients with clear cell renal cell carcinoma after the standard treatment (sunitinib or pazopanib) has failed.

This study will test if denosumab, a drug frequently used to treat osteoporosis, (thinning of the bones), can team up with immune therapy to improve survival and increase the chance of the cancer shrinking for people with clear cell kidney cancer. In the trial, people with advanced clear cell kidney cancer were offered treatment with two antibodies (a type of protein). This trial will investigate if these drugs taken together can increase the ability of the body’s immune system to attack kidney cancer cells. It is hoped that by combining pembrolizumab with denosumab, it will stimulate the immune system, so that the immune therapy will work better in the tumours.

ANZUP collaborated with the University of Sydney through the NHMRC CTC to conduct the KEYPAD Trial.
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