Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase:
Randomized

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

- Unresectable Stage III or Stage IV melanoma

- Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following:
ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed
death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137

- Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for
adjuvant therapy with interferon alpha or melanoma vaccines which are permitted

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)

- Normal liver function tests

Exclusion Criteria:

- Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks
post-radiation treatment, and off steroids are allowed

- Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal
melanoma are excluded

- Autoimmune disease