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
Principal Investigator
Study Number
EA6141
Summary
This is a randomized Phase II study for people with melanoma. Researchers want to learn if using the study drug combination of ipilimumab, nivolumab, and GM-CSF (Sargramostim) is better or worse than using ipilimumab and nivolumab, and to find out what effects, good and bad this drug combination may have on this type of cancer. There are two study groups, Arm A and Arm B, which study participants will be assigned to randomly; participants have a 50-50 chance of being in either group. Arm A will receive nivolumab, ipilimumab, and GM-CSF followed by just nivolumab and GM-CSF. Arm B will receive nivolumab and ipilimumab followed by just nivolumab. Each study participant will be in the study for up to 5 years.
Phase
II/III
Contact
Available at the following location(s)
- Lebanon
View more details at ClinicalTrials.gov
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