Patients with melanoma are needed for a study to research the combination of two immunotherapy drugs with and without the addition of protein injections

IRB/UVA Tracking #
18569
Principal Investigator
Elizabeth M Gaughan
Contact
Nicholas Baker
Contact Email
Contact Phone
434.982.6584
Official Trial Title
Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
Study Description

The University of Virginia Cancer Center is conducting a clinical research study for adults ages 18 and over who have unresectable stage III or IV Melanoma. The purpose of this research study is to compare any good and bad effects of giving 2 immunotherapy drugs (ipilimumab and nivolumab) and the protein, GM-CSF (Sargramostim), at the same time compared to just ipilimumab and nivolumab together. You will be randomly assigned to one of these two groups.

If you choose to participate, you will be treated with both immunotherapy drugs with or without GM-CSF for 4 courses, which takes about 3 months. If your cancer is under control after the 4th course, you will continue therapy on nivolumab with or without GM-CSF, for up to 2 years. After you finish treatment, your doctor will continue to watch you for side effects and follow your condition for 5 years from registration.

Any procedures being done above and beyond standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT02339571

Compensation

N/A