A trial comparing nivolumab and ipilimumab with standard treatment for head and neck cancer (CA209651)

The following bullet points list 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. 

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

• You have squamous cell carcinoma of the head and neck that has come back or spread to another part of your body 
• You are not able to have any treatment such as radiotherapy or surgery to cure your cancer 
• You have a suitable sample of cancer available (or be willing to have a sample taken) to be tested for a biomarker called PD-L1
• Your cancer has been tested for the human papilloma virus (HPV) if you have oropharyngeal cancer. If it hasn’t been tested, then you must have a suitable sample of cancer available (or be willing to have a sample taken)
• You have at least 1 area of cancer that can be seen on a scan and measures at least 10 mm
• You have satisfactory blood tests results
• You are at least 18 years old
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 

Women must be willing to use reliable contraception during treatment and for 23 weeks (about 3 months) after the last dose of nivolumab and ipilimumab if there is any possibility of becoming pregnant. Men must be willing to use reliable contraception during treatment and for 31 weeks (about 8 months) after the final dose of nivolumab and ipilimumab, if there is any possibility their partner could become pregnant. 

If you have standard treatment, the trial team will advise you how long you should use reliable contraception for. 

You cannot join this trial if any of these apply:

Cancer related

• You have had treatment that reached your whole body (systemic treatment ) after your cancer came back or spread to another part of your body
• Your cancer has spread to your brain, the tissues surrounding your brain or your spinal cord . You might still be able to take part if you have had treatment, you no longer have side effects and you haven’t taken, or have been on a stable dose, of steroids for the past 2 weeks
• You have had nivolumab, ipilimumab, cetuximab or any other similar drugs   
• You have had radiotherapy to relieve symptoms (palliative radiotherapy) in the past month (2 months if it was radiotherapy to your head or neck)
• You have, or have had, side effects from previous anti cancer treatment (apart from hair loss and tiredness) in the last 2 weeks  
• You have, or have had another cancer in the past 2 years apart from certain early cancers (carcinoma in situ ) or basal or squamous cell skin cancer that have been successfully treated

Medical conditions

• You have an autoimmune disease  unless it is vitiligo, type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment  
• You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks (unless this was a cream, an inhaler or a very small dose)  
• You have lung problems such as interstitial lung disease that is causing you symptoms 
• You have hearing problems 
• You are having live vaccines  such as the yellow fever vaccine
• You have a serious infection such as shingles  or chickenpox
• You are known to be sensitive to platinum chemotherapy  such as cisplatin, or to the drugs nivolumab or ipilimumab 
• You have HIV 
• You have hepatitis B or hepatitis C
• You have any other medical condition or mental health problem that the trial team thinks could affect you taking part in this trial 

Other

• You are pregnant or breastfeeding