All of Us Research Program
Do you want to change the future of health? The Froedtert & MCW health network is part of the National Institutes of Health All of Us Research Program. It has a simple mission — speed up health research breakthroughs. To do this, All of Us is asking one million people to share their health information. Learn how you can help make a difference by joining the All of Us Research Program.
A Phase 1 Study to Evaluate The Effect Of Hepatic Impairment On The Pharmacokinetics And Safety Of Lorlatinib In Advanced Cancer Patients
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
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. This study will involve
the addition of the FDA approved agent nivolumab to the standard FDA approved
ipilimumab immunotherapy in the hopes that it might further improve the good effects of
the immunotherapy component of the treatment sequence. The combination of
ipilimumab and nivolumab has been shown in recent studies to produce superior
antitumor effects but also more side effects than ipilimumab alone. This combination
has received FDA approval for patients with BRAF V600 wild-type unresectable or
metastatic melanoma. This combination is under review for FDA approval for patients
with BRAF V600 mutant melanoma and is therefore still considered to be experimental
for these patients. 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, including approximately 15 at this site.