Trial Title:

Denosumab and Pembrolizumab in clear cell renal carcinoma: a phase II trial

Trial Acronym:


Protocol Number:

ANZUP 1601

Trial Design:

Single-arm, multi-centre, phase 2 trial

ANZ Study Chairs:

Dr Craig Gedye

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Amasy Alkhateeb

Trial Email:

Recruitment Aim: 
70 participants

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.


Pembrolizumab 200 mg IV every 3 weeks plus denosumab 120 mg SC on day 1, 8, 22 and then every 3 weeks with daily oral calcium and vitamin D, continued until disease progression or prohibitive toxicity.

Primary Outcome:

1. Objective tumour response (OTR = CR or PR, RECIST 1.1) rate (OTRR), and according to iRECIST (secondary endpoint)

Secondary Outcomes:

2. Progression-free survival at 6 months (PFS6m, proportion alive and progression-free at 6 months, RECIST 1.1, iRECIST)

3. OTRR and disease control (DCR = CR, PR, or SD at 6 months, iRECIST) rate (DCRR)

4. Time to objective tumour response (OTR), duration of OTR (RECIST 1.1 and iRECIST)

5. Time to first skeletal related event (SRE)

6. Frequency and severity of adverse events (CTCAE v4.03), particularly selected immune-related adverse events (IRAE)

7. Frequency of treatment delays and discontinuation due to toxicity

Tertiary Correlative:
8. Associations between clinical outcomes and possible prognostic and/or predictive biomarkers (tissue and circulating) including those related to immune and RANK/L signalling.


Active and recruiting

Sites Recruiting:


  • Border Medical Oncology
  • Calvary Mater Newcastle
  • Concord Repatriation General Hospital
  • Northern Cancer Institute
  • St George Hospital
  • St Vincent’s Hospital Sydney
  • ICON Cancer Care
  • Royal Brisbane & Women's Hospital
  • Sunshine Coast University Hospital
  • The Townsville Hospital
  • Eastern Health
  • Monash Health Clayton
  • Ballarat Oncology and Haematology Services
  • Flinders Medical Centre
  • Fiona Stanley Hospital



Further Information:

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