A study of PDR001 in combination with other drugs for advanced cancer

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if you have one of the following:

• bowel cancer that doesn’t have a change in the genes that help repair damage and, or doesn’t have a change in the TP53 gene
• triple negative breast cancer    
• kidney cancer that doesn’t have a change in the TP53 gene    
• non small cell lung cancer that is an adenocarcinoma  

For those who have bowel cancer or kidney cancer, the study team will test a piece of your cancer tissue for the TP53 gene. 

All of the following applies to everyone. You:

• have cancer that has spread to the nearby tissue or to another part of the body
• have had standard treatment for your cancer and it has continued to get worse or you aren’t able to have standard treatment or there is no standard treatment for your cancer   
• have an area of cancer that can be measured
• have an area of cancer that the study team can take a tissue sample (biopsy ) from and you are willing to have tissue samples taken as part of the study
• have satisfactory blood test results
• are able to do everything apart from heavy physical work (performance status 0 or 1)
• are willing to use reliable contraception during treatment and for up to 6 months after if you or your partner could become pregnant. Women using a hormonal contraception in the QBM076 or HDM201 group must be willing and able to change to another type of contraception.
• are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. 

Cancer related
You:

• have symptoms of cancer spread to the brain or spinal cord or you need treatment such as radiotherapy or surgery for the cancer spread or you are having an increasing dose of steroids within 2 weeks of starting treatment 
• have had another cancer apart from cancers that were successfully treated and there hasn’t been any sign of it for the past 2 years, such as successfully treated non melanoma cancers  and carcinomas in situ
• have had an anti cancer treatment that reaches the whole body (systemic treatment) within 2 weeks of the start of treatment, for mitomycin C and nitrosoureas it is within 6 weeks and for immunotherapies it is within 4 weeks. You might not be able to take part if you have had panobinostat or a similar drug before.
• have radiotherapy within 2 weeks of starting treatment apart from radiotherapy to a small area to relieve symptoms such as pain
• still have moderate to severe side effects form previous treatment apart from hair loss, hearing loss and nerve damage affecting the hands and feet 

Medical conditions
You cannot join the study if any of the following apply. You:

• have had a very severe reaction to targeted drugs called monoclonal antibodies
• are allergic to the drugs, or their ingredients, used in the treatment groups. If you are allergic to a particular drug you might be able to join a treatment group that doesn’t have that drug.
• have scarring of the lung tissue (interstitial lung disease) or moderate to severe inflammation of the lungs (pneumonitis) caused by medication
• have heart problems such as a heart attack or angina in the past 3 months, congestive heart disease or irregular heart beats
• have an autoimmune disease apart from vitiligo, type 1 diabetes, hypothyroidism caused by an autoimmune disease that needs hormone replacement treatment, psoriasis not needing treatment that reaches the whole body or any other previous autoimmune disease that is not likely to come back
• have HIV, active hepatitis C or active hepatitis B
• have problems with the digestive system  that will affect how well tablets and capsules are absorbed by the body
• have an active infection that needs antibiotics
• are taking steroids apart from as replacement for adrenal gland problems, creams, inhalers, nose spray and eye drops
• are taking any other drugs that affect how your immune system works
• have major surgery within 2 weeks of starting treatment
• have had a growth factor to increase your red blood cells within 3 weeks of starting treatment
• have any other medical or mental health condition that your doctor or the study team think could affect you taking part
• have an experimental drug as part of another clinical trial within 2 weeks of starting treatment
• are taking medication that affects the CYP enzymes unless you are able to stop them or have a different medication 

Other
You cannot join this study if any of the following apply. You:

• have a live vaccination  within 4 weeks of starting treatment or need a live vaccination during treatment
• are pregnant or breastfeeding