Expanded Access Program With Nivolumab to Treat Melanoma (Checkmate 168)

Bristol-Myers Squibb (BMS)

Status

Conditions: Stage III (Unresectable) or Stage IV Advanced Melanoma

Treatments: Drug: Nivolumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02142218

CA209-168

Details and patient eligibility

About

The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• ECOG Performance Status of 0-1
• Histologically confirmed malignant melanoma
• Progressed on or after treatment with an anti-CTLA4

Exclusion Criteria:

• Active brain metastases
• Life Expectancy <6 weeks
• Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy
• Subjects with autoimmune disease