New potential breakthrough study opened for non muscle invasive bladder cancer as alternative to bladder removal (cystectomy) if cancer comes back after BCG

Dr Thompson together with Dr Patti Bastick (Oncologist), Dr Carole Harris (Oncologist) and the Clinical Trials Unit team at St George Hospital Sydney are excited to have this week opened a new trial of a potential breakthrough drug for men & women diagnosed with bladder cancer whose cancer ‘grows back’ (recurs) within the bladder after initial treatment.

Bladder cancer is unfortunately a common cancer and can be lethal if not treated promptly. It can affect men and women of all ages. Initial treatment if high grade (fast growing) and diagnosed early is usually with BCG (Bacillus Calmette Guerin a Tb vaccine which is injected into the bladder at weekly intervals as first line treatment for bladder cancer).

Unfortunately 30-50% (1 in 3 or even up to half) find that their cancer recurs (comes back in the bladder). The current recommendation in this situation is to remove the entire bladder, but this big operation has major risks and lifelong consequences.

There is an urgent need, therefore, for new treatments when BCG fails and the cancer recurs, that allow people to keep their bladder.

We are therefore excited to join the new CA209-9UT study led by Bristol Myers Squibb. This is a phase 2 trial in which patients recurring after BCG will be randomly allocated to one of 3 treatment ‘arms’:

1) nivolumab - a new type of drug called ‘immunotherapy’ which binds to and blocks the PD-1 receptor on a person’s white blood cells (T Cells); these are the cell which control the body’s immune system response to cancer; it appears that nivolumab can stop cancer cells from evading the immune system.

2) nivolumab plus bcg - it is possible that even though the bcg alone didn’t work, combining the two will be more effective

3) nivolumab plus bcg plus IDO1i - this 3rd drug is another ‘immune system booster’ . cancer cells try to evade the immune system via this IDO1 receptor so it is possible that the combination of the 3 drugs will be even more effective in fighting off bladder cancer cells.

Dr Thompson has already seen his first patient who may be eligible for this trial within the first week of opening, so hopefully more patients in this difficult situation can come forward and join the trial in the hope that it is effective in saving bladders, improving quality of life for those living with bladder cancer and most importantly in saving lives.

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