A trial of talimogene laherparepvec for advanced melanoma

The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you. 

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

• Have melanoma that has spread to another part of the body (advanced melanoma) and can’t be completely removed by surgery  
• Have a single area of melanoma at least 10mm across (diameter) that talimogene laherparepvec can be injected into or ​have a number of smaller areas of melanoma that can be injected into and the total of the diameters of each area  adds up to at least 10mm
• Have melanoma that can be measured
• Have satisfactory blood test results
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant and are willing to use male or female latex condoms during treatment and for 30 days afterwards to avoid the possibility of passing on talimogene laherparepvec
• Are at least 18 years old

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

• Have melanoma that first started in the eye (primary melanoma of the eye) or in mucosal  tissue (mucosal melanoma ) 
• Have melanoma spread to the brain that hasn’t been treated. You may be able to join if you have had no more than 3 areas of melanoma spread to the brain. And you had treatment with stereotactic radiotherapy or surgery, there is no sign of the areas growing and you haven’t needed steroids for the past 2 months 
• Have more than 3 areas of melanoma spread to other organs in the body, such as liver, spleen or kidneys apart from the lungs and any lymph nodes near other organs of the body
• Have melanoma that has spread to the bones
• Have had treatment for melanoma that reached your whole body (systemic treatment ) such as chemotherapy in the past 28 days
• Currently have an outbreak of herpes infection or a recurrence
• Have had complications such as inflammation of the eye or inflammation of the brain caused by herpes infection
• Are taking medication by mouth or as an injection such as acyclovir to treat herpes apart from the occasional use of cream  
• Have or have had symptoms of an autoimmune disease
• Have needed systemic treatment for an autoimmune disease apart from treatment that replaces something in the body such as insulin 
• Have a weakened immune system due to another disease such as an infection
• Have taken medication such as steroids that affect the immune system in the past 2 months
• Have HIV, hepatitis B or hepatitis C
• Have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer , some early cancers or any other cancer treated with the aim to cure, with no sign of it for at least 3 years and a low risk of coming back 
• Have already had talimogene laherparepvec
• Have had an experimental drug or used an experimental device as part of another clinical trial in the past 28 days
• Are sensitive to talimogene laherparepvec or any of its ingredients 
• Have another medical or mental health problem that the trial team think could affect you taking part 
• Are pregnant or breastfeeding