Clinical Trials

Clinical trials are used to try and improve ways of treating cancer or reducing possible side effects of treatment. If you are being treated for penile cancer which has spread to other areas of your body, you may be asked if you wish to take part in a clinical trial involving a combination of treatment, or immunotherapy. If you agree to take part, you can still opt out of the trial in the future without affecting your care or treatment.

InPACT Trial

Researchers are trying to find out whether surgery to remove lymph nodes in the abdomen after chemotherapy or radiotherapy is better than surgery on its own. Or, whether a different operation to remove lymph nodes in the abdomen is better than standard surgery. Chemotherapy is a common treatment for penile cancer that has spread to nearby or distant sites in the body. There are several different chemotherapy drugs and drug combinations available.

Doctors are interested in how to improve treatment for penile cancer that has spread. To do this, they are looking at a new immunotherapy drug called cemiplimab.

It is a type of drug called a monoclonal antibody. It works by triggering the immune system and helping it to attack the cancer cells.

Researchers are looking at cemiplimab on its own and with standard chemotherapy drugs.

The aims of this trial are:

  • to see how well cemiplimab works on its own, and with chemotherapy, for penile cancer that has spread
  • to learn more about the side effects of treatment
  • to find out about the quality of life of people taking part

EPIC Trial

Researchers are trying to find out if immunotherapy treatment (see below) on its own or in combination with chemotherapy can reduce cancer that has spread to other parts of the body.


Immunotherapy is a treatment that uses your own immune system to fight tumour cells. It can cause cancer to shrink or sometimes disappear altogether.

Side Effects of Immunotherapy

Immunotherapy can cause mild, moderate, and even severe side effects. The most common include fatigue and flu-like symptoms, such as fever and chills, headaches, and pain in the muscles and joints. This is due to the body’s immune system becoming activate. Nearly everyone undergoing immunotherapy has these side effects at first. It usually gets better as treatment continues. Paracetamol can help to relieve these symptoms.

Immunotherapy can also have a temporary effect on blood cells in the body which may increase the risk of infection and make you feel tired or out of breath. Sometimes rashes may appear. Other symptoms include nausea and vomiting, diarrhoea, loss of appetite, and changes in taste or a metallic taste in your mouth. You could also experience a sore throat and pain when swallowing. Because these symptoms may lead to dehydration, weight loss, or malnutrition, be sure to let your doctor or nurse know if they do not go away.

During treatment, you may feel depressed, anxious, or have trouble sleeping. These feelings can be a side effect of immunotherapy, but they may also be a response to your diagnosis. You can ask your medical team about psychological support if you feel you need to have someone to talk to.

    We hope you found this information useful. If you would like to submit your own advice based on your experience to help other men, please comment below. Comments will be kept anonymous, but where possible and we would like to share them with other orginisations who are trying to improve the care and support for anyone affected by penile cancer.