Spots Global Cancer Trial Database for Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma
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Trial Identification
Brief Title: Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma
Official Title: A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients With Unresectable Stage III and IV Melanoma
Study ID: NCT03161756
Study Description
Brief Summary: The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for many years to help treat cancers such as prostate cancer and breast cancer, but it is not currently used in melanoma. We hope the addition of denosumab to current melanoma therapies will make these treatments work better without adding to the side effects. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with metastatic melanoma (melanoma that has spread). Study details: Nivolumab and ipilimumab are approved treatments for advanced melanoma in Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study, are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as standard care. However, there is limited information on the effectiveness and safety of these treatments in combination with denosumab. Recent melanoma research in animal models has shown that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because denosumab has been used in patients with breast and prostate cancer for a long time and is safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in this study.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Bendigo Health, Bendigo, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Alfred Health, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Contact Details
Name: A/Prof Shahneen Sandhu
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR
Name: Prof. Grant McArthur
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR
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