A trial of nivolumab and temozolomide with radiotherapy for people with brain cancer (CA209498)

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 a newly diagnosed GBM  
• Your cancer has a change in the MGMT gene (unmethylated MGMT) – your doctor will check for this 
• You have had treatment with surgery  
• Your doctor thinks you are able to have radiotherapy 
• You have had an MRI scan within 72 hours of your surgery
• You have satisfactory blood tests results 
• You are able to care for yourself, even if you aren’t able to carry on with all your normal activities (Karnofsky performance status of 70 or more)
• You are at least 18 years old
• You are willing to use reliable contraception during treatment and for 23 weeks after the final dose of nivolumab if you are a woman, or 31 weeks if you are a man, if there is any possibility you or your partner could become pregnant. If you have temozolomide, you must use contraception for 6 weeks if you are a woman or 6 months if you are a man. 

You cannot join this trial if any of these apply.

Cancer related

• You have had treatment for GBM apart from surgery  
• You have a GBM that has come back after previous treatment (recurrence) 
• You have a type of GBM called MGMT methylated, partially methylated, indeterminate GBM or with a change in the IDH gene  (IDH mutated GBM) 
• Your cancer has spread outside your skull or the tissues surrounding your brain (leptomeningeal disease) 
• Your GBM has changed from a low grade (benign tumour) or anaplastic glioma to a high grade (malignant tumour)
• You only had a small amount of cancer removed during surgery (less than 20%)
• You still have side effects from your surgery
• You have had a moderate or serious bleed in your central nervous system (CNS) that hasn’t got better  
• You have had drugs that affect certain proteins called PD-1, PD-2, CTLA-4 or certain immune cells called T-cells  

Medical conditions

• You have an autoimmune disease unless it is vitiligo, type 1 diabetes, thyroid problems that are controlled by medication, hair loss (alopecia) or a skin condition called psoriasis that doesn’t need treatment  
• You take more than 20 mg of a drug called prednisone every day (3 mg if it is dexamethasone) or you have had any other drug to damp down the immune system in the last 2 weeks (unless it is a cream or an inhaler)
• You have lung problems such as interstitial lung disease and it’s causing symptoms 
• You have (or have had) problems that affect your central nervous system such as fits (seizures) that aren’t related to your brain cancer, unless these are controlled with medication
• You have HIV
• You have hepatitis B or hepatitis C
• You have any other serious medical condition that the trial team think could affect you taking part

Other

• You have had a surgery in the past 7 days (unless it was to place a central line )
• You are known to be allergic to the drugs in this study, anything they contain, to any other drug that increases the amount of antibodies in the body (immunoglobulin) or the chemotherapy drug dacarbazine 
• You are not able to have an MRI scan for any reason, for example you have metal implants such as a pacemaker, surgical clips, pins or plates or cochlear implants (for deafness), you have a fear of being in closed spaces (claustrophobia) or you are sensitive to the injection given during an MRI scan (known as contrast medium )
• You are unable to swallow and absorb tablets 
• You are pregnant or breastfeeding