A trial of BMS-986205, nivolumab and chemotherapy for bladder cancer (CA017078)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

• have cancer that has grown into the muscle wall in the bladder (stage T2-T4a) but it hasn’t spread to the lymph nodes . You might be able to take part if you have tiny areas of cancer in the nodes that are smaller than 10mm. 
• have cancer that hasn’t spread to distant parts of the body 
• are suitable to have surgery to remove the bladder (radical cystectomy) and agree to have it 
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
• have a tissue sample that shows if your cancer has the PD-L1 protein or not 
• are willing to use reliable contraception if there is any chance you or your partner could become pregnant
• have satisfactory blood test results 
• are at least 18 years old

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

• have had treatment for bladder cancer in the past such as chemotherapy, immunotherapy, radiotherapy or surgery for bladder cancer. This doesn’t include surgery to treat early bladder cancer (a TURBT) or having tissue samples taken. 
• had had an immunotherapy  or a similar drug in the past 
• have cancer that has spread to the lymph nodes unless it measures less than 10mm on a scan  
• have cancer that has spread to distant parts of the body 
• can’t have cisplatin because you have moderate to severe tingling or numbness in your hands or feet, you have hearing loss or your kidneys aren’t working well  
• have had another cancer in the last 3 years. This is apart from successfully treated non melanoma skin cancer , carcinoma in situ (CIS ) of the cervix, prostate, or breast or early bladder cancer. 
• have had an experimental treatment within 4 weeks of starting trial treatment 

Medical conditions
You cannot join this trial if any of these apply. You:

• have an active autoimmune disease  that needed treatment in the last 2 years apart from certain ones. The trial team check this before you can join the trial. 
• have problems with your digestive system   that means you can’t absorb medication you take by mouth 
• have a problem with your immune system  or are taking medication to damp it down unless it is a low dose
• have a problem with how your adrenal glands  work and they don’t make enough hormones  
• have a serious heart problem such as a heart attack in the last 6 months or another heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. 
• have had a stroke in the last 6 months 
• bleed or bruise easily or you have problems with how your blood clots. You may join the trial if you are taking medication to thin your blood as long as you are on a stable dose.  
• have a condition that causes you to have low levels of oxygen in your blood (cytochrome b5 reductase deficiency) or a close family member has this condition 
• have a condition called methemoglobinemia
• have a condition called G6PD deficiency or disorder in which red blood cells are destroyed faster than they can be made
• have a condition called serotonin syndrome
• have a lung condition called interstitial lung disease or inflammation of the lungs or you had this in the past and needed to have steroids to treat it. This doesn’t include pneumonitis caused by radiotherapy.
• have had major surgery within 14 days of being put into a treatment group or you need to have a major operation
• have HIV, AIDS, an active hepatitis B or hepatitis C infection or any other infection that needs treatment
• have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part

Other 
You cannot join this trial if any of these apply. You:

• have had a live vaccine  within 30 days of starting trial treatment. Please note that the current approved COVID-19 vaccines are allowed as they aren’t a live. 
• have had herbal supplements or traditional Chinese medicines to treat your cancer within 2 weeks of starting trial treatment
• are allergic to the trial drugs or anything they contain 
• are pregnant or breastfeeding