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UNISoN

 Kidney — Closed

In this clinical trial ANZUP will test whether new immune treatments can help people with rare kidney cancer (‘non-clear cell’ cancer). Non-clear cell kidney cancer represents approximately 25% of people with kidney cancer; and because it is rare there are no treatments currently reimbursed in Australia.

The UNISoN trial is now closed. This trial is investigating immune treatments in two different ways; firstly the trial is investigating how well one immune treatment (nivolumab) works alone. If this is unhelpful by itself, then people can continue taking nivolumab but also add in a 2nd immune treatment (ipilimumab). The trial will also discover how many people will benefit from one drug alone, and by doing detailed laboratory testing of people’s cancer samples, we hope to also learn who will only benefit from taking both treatments together.

Nivolumab and ipilimumab have been used alone or together in many cancers, so the side-effects are well known and should be manageable. Immune treatments help some people with cancer, especially those with melanoma, common (clear cell) kidney cancer, lung and bladder cancer. Unfortunately they are much less effective in other cancers (like pancreas, prostate and brain cancers). Nivolumab and ipilimumab have not been tested in people with non-clear cell kidney cancers, so ANZUP is delighted to ask this question, and hopes to help people with this rare disease.

We thank and acknowledge BMS for providing the study drug and funding to conduct the UNISoN trial.

If you think this trial might be right for you, please ask your doctor.

TRIAL TITLE

UNISoN: anzUp Nivo -> Ipi + Nivo Sequential Non-clear cell Proposed phase II sequential cohort trial of single agent Nivolumab, then combination Ipilimumab + Nivolumab in Metastatic or unresectable non-clear cell renal cell carcinoma

CONSUMER TITLE

Study testing whether immunotherapy (nivolumab with or without ipilimumab) can improve outcomes for people with less common types of advanced kidney cancer (non-clear cell kidney cancer).

CANCER TYPE

Kidney

TRIAL STATUS

Closed

PROTOCOL NUMBER

ANZUP 1602

STUDY CHAIR

Associate Professor Craig Gedye

PATIENT POPULATION

Adults with m-n-ccRCC. Key eligibility criteria include target lesion(s) according to RECIST 1.1, good performance status (ECOG 0-1), no history of significant autoimmune disease, tumour sample available (previously resected or fresh biopsy) and no previous treatment with immunotherapy.

RECRUITMENT TARGET

85 participants (Part 1) 48 participants (Part 2)

ACKNOWLEDGEMENT

DETAILED INFORMATION