An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Status:	Active, not recruiting
Conditions:	Skin Cancer, Skin Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	12 - Any
Updated:	2/3/2019
Start Date:	November 21, 2017
End Date:	July 31, 2020

A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to
nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to
be removed by surgery, and has not previously been treated

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

Inclusion Criteria:

- 12 years and older unless not permitted by local regulations; in that case 18 years
old and older

- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
1

- Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the
American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)

- Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or
metastatic melanoma)

- Measurable disease per RECIST v1.1

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Uveal or ocular melanoma

- Participants with active, known, or suspected autoimmune disease

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured

Other protocol defined inclusion/exclusion criteria could apply

We found this trial at

sites

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida 33140

Phone: 305-674-2625

from

Miami Beach, FL