Melanoma

THIS TRIAL IS NOW CLOSED

Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti_CTLA-4 Monoclonal Antibody (CheckMate 168)

Investigator:  Bill G Schmidt, MD

Status: Recruiting

Sponsor: Bristol-Myers Squibb

Contact: Christine Reed, 541-706-6592 or creed@bmctotalcare.com

Location: Bend, Oregon (Central Oregon)

Purpose: The primary purpose of this study is to provide treatment with Nivolumab to subjects with histologically confirmed stage III (unresectable) or stage IV advanced melanoma who have progressed on or after prior treatment with an anti-CTLA4-containing therapy and for subjects with known BRAF mutation, also progressed on or after treatment with a BRAF inhibitor.

Inclusion Criteria:

• ≥ 18 years of age
• Histologically confirmed malignant melanoma, Including mucosal melanoma
• Previously treated unresectable med stage III or stage IV melanoma, as per American Joint Committee on Cancer staging system
• Eastern Cooperative Oncology Group (ECOG) perform status (PS) 0-1
• Progressed on or after prior treatment with an anti-CTLA4-containing therapy and, for subjects with known BRAF mutation, also progressed on or after treatment with a BRAF inhibitor

Exclusion Criteria:

• Active brain metastases or leptomeningeal metastases
• Life expectancy <6 weeks
• Subjects with active, known or suspected autoimmune disease
• Subjects with a known history of anti-CTLA-4 therapy related adverse reactions based on the CTCAE v criteria
• Any treatment in a Nivolumab clinical trial

See this trial at ClinicalTrials.gov

For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.

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