ECOG-ACRIN / EA6141

Official 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 Purpose

To compare any good and bad effects of giving three drugs- ipilimumab, nivolumab, and sargramostim at the same time compared to just ipilimumab and nivolumab together.

Diagnosis

Must have unresectable stage III or stage IV melanoma and have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.

Eligibility

May have had prior systemic therapy in the adjuvant setting. No prior PD-1/PD-L1 in the adjuvant setting.

May not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in a metastatic setting.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• Arm A:  Patients will receive nivolumab, ipilimumab, and sargramostim for induction phase. Maintenance phase will include just nivolumab and sagramostim.
• Arm B:  Patients will receive nivolumab and ipilimumab for induction phase. Maintenance phase will include just nivolumab.

Patients will receive protocol therapy until progressive disease, non-protocol therapy, or up to two years, whichever comes first.

Patients will be followed for 5 years from date of randomization.