A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Status:	Active, not recruiting
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/29/2018
Start Date:	March 24, 2016
End Date:	April 15, 2022

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The purpose of this study is to evaluate two different dose combinations of nivolumab and
ipilimumab in the treatment of melanoma.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Subject must have been diagnosed with stage III or/and stage IV histologically
confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that
is unresectable or metastatic

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

- Subject has not been treated by systemic anticancer therapy for unresectable or
metastatic melanoma

Exclusion Criteria:

- Subjects with active brain metastases or leptomeningeal metastases

- Subjects with ocular melanoma

- Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

We found this trial at

sites

H. Lee Moffitt Cancer Center

Tampa, Florida 33612

from

Tampa, FL