A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Melanoma

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03980314

CA209-8FC

2018-002993-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.

Enrollment

261 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion criteria

Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
Any significant acute or chronic medical illness that is uncontrolled
History of ocular/uveal melanoma
Active, known or suspected autoimmune disease
Systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply