Acronym:
ANZUP1601
ACTRN/NCT /ethics:
ACTRN12618000132246
Scientific title:
Denosumab and Pembrolizumab in clear cell renal carcinoma
Summary of trial and patient characteristics
| Cancer Type | Kidney | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase II | Tumour Stream | Kidney |
| Age Range | 18 years and older | Cancer Stage | All stages |
| Sex | Both | Anticipated Start Date | 2017-12-12 |
| Molecular Target | Anticipated End Date | 2019-12-31 | |
| Cancer Type | Kidney |
|---|---|
| Trial Type | Treatment |
| Phase | Phase II |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | Kidney |
| Cancer Stage | All stages |
| Anticipated Start Date | 2017-12-12 |
| Anticipated End Date | 2019-12-31 |
Trial Summary
This study is designed to test the safety and potential benefit of adding an existing drug used for bone protection (denosumab) to a new immune stimulating drug (pembrolizumab). Who is it for? You may be eligible for this study if you have a confirmed unresectable or metastatic clear cell renal carcinoma, and you have adequate liver and bone function. Study details All participants will receive the two study drugs, along with vitamin D and calcium (mode of administration up to the discretion of the treating clinician). Treatment will continue until disease progression or toxicity. Patients will be monitored for tumour response and skeleton health. It is hoped this combination of medications will be as safe, and provide more benefit than the immune stimulating drug alone in treating kidney cancer.
Lay Summary
Denosumab and Pembrolizumab in clear cell renal carcinoma
Sponsor / Cooperative group
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Flinders Medical Centre | Alex Scott-Hoy | alex.scott-hoy@sa.gov.au | 08 8204 4830 | Ganessan Kichenadasse | Recruiting |