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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

Protocol No
ECOG-EA6141
Principal Investigator
Amy Harker-Murray
Phase
II/III
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. 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.
Description
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. 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.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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