Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Potential subjects must have advanced Melanoma (stage III or IV as confirmed by
biopsy) with spread to other sites in the body and unable to be removed by surgery

- Potential subjects must be newly diagnosed with advanced Melanoma and received no
treatment for the advanced disease The subjects who received previous primary
treatment and any additional treatment (which is given after the primary treatment)
are permitted if it was completed at least 6 weeks prior to study entry and if the
side effects of the treatment are resolved If subjects received any of the following
primary treatment previously; they are not permitted to be enrolled in the study
(anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other drug specifically
targeting T-cell costimulation or checkpoint pathways such as anti-CD-137)

- Potential subjects (with disease spread to brain) who previously received primary
treatment are permitted if there was no evidence of disease as confirmed by the MRI
(at least 2 weeks after the primary treatment is complete and with in 6 weeks of the
first dose of the study drug) Potential subjects must not have received intravenous
steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug
administration.

Exclusion Criteria:

- There is no current (and not previously treated) disease spread to the brain

- Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti PD-L1 or
anti-PD-L2, anti-CD-137 agents (or any other antibody or drug specifically targeting
T-cell costimulation or checkpoint pathways) for adjuvant, neo-adjuvant, or advanced
melanoma treatment or as part of clinical trial

- Subjects with autoimmune disease. Subjects with Type I diabetes mellitus,
hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo,
psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected
to recur in the absence of an external trigger are permitted to enroll

- All side effects from previous primary treatments other than alopecia, fatigue, or
peripheral neuropathy must have resolved to Grade 1 or baseline before administration
of study drug