This phase 2 trial will investigate the effect of vopratelimab (JTX-2011) and ipilimumab (Yervoy) in non-small cell lung cancer (NSCLC).
The main outcome will be the overall response (OR). This trial is recruiting at multiple locations in the US.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (LC). LC is typically diagnosed at an advanced stage. Some patients do not respond to chemotherapy (CT) in advanced disease. Some patients may also be resistant to CT. This is called refractory NSCLC. New drugs are being developed to treat advanced cancers. One such drug is vopratelimab. Vopratelimab is an antibody that binds to a protein called ICOS. This stimulates an immune response that can target and kill cancer cells.Ipilimumab is a CTLA-4 inhibitor (CTLA4i). CTLA4i drugs are known as immune checkpoint inhibitors (ICIs). ICIs help the immune system to recognize and kill cancer cells.
This trial will investigate the effect of vopratelimab and ipilimumab in NSCLC. The main outcome will be the OR.
Who are they looking for?
This trial will recruit 226 patients with advanced NSCLC or urothelial cancer. Patients should have had treatment with another type of ICI (PD-1/PD-L1 inhibitors) in the past for at least 3 months. Participants that are capable of conceiving a child must use highly effective contraception. They must also have negative pregnancy tests at the beginning and during the trial. Male partners of female participants must also use contraception.
Patients cannot take part if they are having any cancer treatment. Recent treatment with certain drugs. Patients with a history of the following conditions/events cannot take part in the trial: major surgery, recent vaccination, immune-related events, active disease, brain tumors, infection, heart disease.
How will it work
Patients will be assigned to one of two groups. Both groups will receive vopratelimab and ipilimumab. The doses will be different. Treatment will continue for up to 34 months.
The main outcome will be the OR. Side effects and survival will also be evaluated.