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Brief Title: Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602)
Official Title: A Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602).
Study ID: NCT03177239
Brief Summary: This study aims to evaluate the safety, tolerability and effectiveness of new treatments for kidney cancer called Nivolumab and Ipilimumab. The study is in two parts; in the first instance patients receive nivolumab alone. If this treatment is not effective patients may move onto the second part of the trial, where they receive nivolumab + ipilimumab. There is no placebo. The reason to offer one treatment alone, followed by two treatments together is that it is thought that the double treatment may have more side-effects, but also may be effective in people in whom the single first treatment (nivolumab alone) has not helped. Nivolumab and ipilimumab are experimental treatments. This means that they are not an approved treatment for non-clear cell kidney cancer in Australia. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab (also known as Opdivo or BMS-936558) and Ipilumumab (also known as MDX-010 or Yervoy). Nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if they will allow the body's immune system to work against tumour cells. The immune system is the body's defence against cancer, bacteria and viruses. The effectiveness of nivolumab and ipilimumab in cancer of the kidney will be assessed by measuring the size of patient tumours via CT scans. Nivolumab and ipilimumab have been used alone or in combination in many other cancers, and are licenced for use in other cancers like advanced melanoma and bladder cancer in Australia. They have not been tested in people with non-clear cell kidney cancer. About 85 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia and New Zealand. This research study has been initiated by Dr. Craig Gedye, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Bristol Myers Squibb (BMS) is supplying the study drugs and grant funding for this research.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Border Medical Oncology, Albury, New South Wales, Australia
Campbelltown Hospital, Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St Vincents Hospital, Darlinghurst, New South Wales, Australia
Northern Cancer Institute, Frenchs Forest, New South Wales, Australia
St. George Hospital, Kogarah, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Tamworth Hospital - North West Cancer Centre, Tamworth, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Sunshine Coast University Hospital, Birtinya, Queensland, Australia
Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia
Flinders Medical Centre, Adelaide, South Australia, Australia
Ashford Cancer Centre, Adelaide, South Australia, Australia
Ballarat Oncology & Haematology Services, Ballarat, Victoria, Australia
Box Hill Hospital - Eastern Health, Box Hill, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia