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Trial from ANZCTR

Denosumab and Pembrolizumab in Clear Cell Renal Carcinoma: a Phase II Trial (ANZUP 1601)

  • Recruitment status at the time of last update
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 3/4/2019)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID


Date registered

30 January 2018

Health condition

Metastatic Kidney Cancer, Renal Cell Carcinoma, Clear Cell

Recruitment countries


Recruitment site location(s) (State)

New South Wales, Queensland, South Australia, Western Australia, Victoria

Recruitment status


Anticipated date of first participant enrolment


Ethics application status


Brief 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.


Key inclusion criteria

- Adults, aged 18 years and older, with histologically confirmed unresectable or
metastatic renal cell carcinoma with a clear cell component

- Disease progression during or after VEGFR TKI treatment

- At least 1 target lesion according to RECIST v1.1

- ECOG performance status of 0-2

- Adequate bone marrow function (done within 14 days prior to registration

- Haemoglobin greater than or equal to 90g/L

- Platelet greater than or equal to 75x109/L

- Neutrophil count greater than or equal to 1.5x109/L

- Adequate liver function (done within 14 days prior to registration and with values
within the ranges specified below):

- Bilirubin less than or equal too 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's

- AST or ALT less than or equal too 3.0 x ULN (or less than or equal too 5.0x ULN in the presence of liver metastases)

- Adequate renal function (done within 14 days prior to registration and with values
within the ranges specified below):

- Creatinine less than or equal to 1.5x ULN OR

- Creatinine clearance (CrCl) greater than or equal to 30mL/min

- Serum calcium or albumin-adjusted serum calcium greater than or equal to 2.0 mmol/L

- Tumour tissue available for tertiary correlative studies

- Willing and able to start treatment within 14 days of registration, and to comply with
all study requirements, including the timing and/or nature of the required treatment
and assessments

- Signed, written informed consent

Minimum age

18 Years

Maximum age

No limit


Both males and females

Key exclusion criteria

- Prior treatment with pembrolizumab, or with any other anti-PD-1, anti-PD-L1,
Anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
T cell co-stimulation or immune checkpoint pathways

- Active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.

- Any condition requiring systemic treatment with either corticosteroids (>10mg daily
prednisone or equivalent dose of alternative corticosteroid) or other
immunosuppressive medications within 14 days of pembrolizumab administration.
Intranasal, inhaled or topical steroids are permitted in the absence of active
autoimmune disease.

- Prior treatment with denosumab.

- Untreated brain or leptomeningeal metastases or current clinical or radiological
progression of known brain metastases, or requirement for steroid therapy for brain
metastases. Patients with treated brain metastases are eligible if they have been
stable and off steroids for over than or equal too 3 weeks.

- Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis,
tuberculosis, or primary immunodeficiency

- Active infection requiring systemic therapy within 14 days before the first dose of

- Receipt of live attenuated vaccination within 30 days of the planned first dose of

- Active dental or jaw condition that precludes administration of denosumab:

i) Significant dental/oral disease, including prior history or current evidence of
osteonecrosis/osteomyelitis of the jaw, or; ii) Active dental or jaw condition which
requires oral surgery, or; iii) Non-healed dental/oral surgery, or; iv) Planned
invasive dental procedures during the course of the study

- Clinically significant hypersensitivity to denosumab or any components of denosumab

- Targeted small molecule therapy, surgery or radiation therapy within 2 weeks before
registration, or persisting adverse event(s) of Grade 2 or more due to a previously
administered agent. Note that participants who have had recent major surgery must have
recovered adequately before registration.

- Life expectancy of less than 3 months.

- History of an active malignancy within the previous 5 years, except for locally
curable cancers that have been apparently cured, such as low-grade thyroid carcinoma,
prostate cancer not requiring treatment (Gleason grade less than or equal too 6), basal or squamous cell
skin cancer, superficial bladder cancer, melanoma in situ, or carcinoma in situ of the
prostate, cervix, or breast. Patients who have been free of other malignancies for greater than or equal than 5 years prior to registration are eligible for this study.

- Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. -
Serious medical or psychiatric conditions that might limit the ability of the patient
to comply with the protocol

- Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal,
infertile, or use a reliable means of contraception. Women of childbearing potential
must have a negative pregnancy test done within 7 days prior to registration. Men must
have been surgically sterilised or use a (double if required) barrier method of
contraception. Subject is excluded if pregnant or breast feeding, or planning to
become pregnant within 5 months after the end of treatment. Female subject of child
bearing potential is excluded if they are not willing to use, in combination with her
partner, highly effective contraception during treatment and for 5 months after the
end of treatment.

Contact details and further information

Primary Sponsor

Type: Other
Name: Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address: Level 6, Lifehouse Building, 119-143 Missenden Road, Camperdown NSW 2050
Country: Australia

Contact person for information and recruitment

Ms Jaclyn Verghis
ANZUP Level 6, Lifehouse Building, 119-143 Missenden Road, Camperdown NSW 2050
+6128036 5271