A study of INCB099318 for advanced solid cancers

The following bullet points are a summary of 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 all of the following apply. You:

• have a solid cancer  that has spread from where it started 
• have an area of cancer that the doctor can measure 
• have cancer that cannot be treated with the aim to cure
• have had all the available treatment for your cancer and it continued to get worse
• are willing to have a small piece of tissue (biopsy ) taken from your cancer 
• can look after yourself but may not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• must be willing to use contraception during the study and for a certain time after if there is any chance you or your partner could become pregnant
• are at least 18 years old

There are other parts to this study you might be able to join. Your doctor will know if you can. 

Who can’t take part

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

• can have the standard treatment  for your cancer  
• have cancer spread to the brain or spinal cord. You might be able to join if it has been treated, is stable and you don’t need steroids for at least 1 week before study treatment. 
• have another cancer that needs treatment or is getting worse. This is apart from successfully treated non melanoma skin cancer , in situ cancer  of the cervix and early stage  endometrial cancer. 
• still have side effects from previous treatment. This is apart from hair loss. And some other side effects that your doctor will know about. 
• have had other cancer treatment including experimental drugs within a certain time of starting study treatment. Your doctor will know what the time is for which drugs. 

You cannot join part 1 of the study if you have cancer spread to a fifth (20%) or more of your liver. Your doctor can tell you more about this. 

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

• have had chest pain (angina) or a heart attack within 6 months of starting treatment. Or you have another heart problem .
• have an autoimmune disease  that needed systemic treatment  in the past 2 years. This is apart from certain autoimmune diseases. Your doctor will know which ones. 
• have an immune system  that isn’t working very well. You are taking medication such as steroids that affect how well your immune system works.
• have a disease of the lung tissue. You have inflammation of the lung that is active and not infectious.
• have had a targeted drug for you cancer called a PD-L1 antibody. Your doctor will know if you have had this. 
• have had more than 1 immunotherapy  treatment before
• are taking medication that affects the CYP enzymes. You might be able to join if you can stop taking these before starting the study treatment. 
• have HIV, active hepatitis B or hepatitis C or any active infection needing treatment
• had an antibiotic within 28 days of starting the study treatment
• have a problem with your digestive system  that affects how well your body can absorb medication 
• have any other medical condition or mental health problems that could affect you taking part

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

• take probiotics just before going into the study or during the study
• have a live vaccine  within 30 days of starting study treatment
• are allergic to the treatment or any of its ingredients
• are pregnant or breastfeeding