EA6141- 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 ID
STU 102015-033

Study Sites

  • Zale Lipshy University Hospital

Contact
Pamela Kurian
214/648-5874
pamela.kurian@utsouthwestern.edu

Principal Investigator
Jade Homsi, M.D.

Summary

The purpose of this research study is to compare any good and bad effects of giving ipilimumab, nivolumab, and GM-CSF (Sargramostim) at the same time compared to just ipilimumab and nivolumab together. We would also like to find out what effects, good and bad, that this combination of drugs may have on your cancer. nivolumab and ipilimumab are experimental agents. The addition of nivolumab plus ipilimumab to the usual chemotherapy could shrink your cancer/prevent it from returning, but it could also cause side effects. GM-CSF is a protein that your body normally produces to signal to your body to make white blood cells. White blood cells are very important in the body's defense system as they help identify and destroy foreign invaders, such as bacteria, viruses, and cells that don't belong, such as cancer cells. injections of GM-CSF increase your body's production of white blood cells and also help enhance the function of the white blood cells. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drugs should improve how long you are able to live with your cancer compared to the usual approach. There will be about 400 people taking part in this research study.

Participant Eligibility