Melanoma
Conditions
Brief summary
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.
Interventions
DRUGNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h) | Over the dosing interval at Week 1 and Week 17 |
Secondary
| Measure | Time frame |
|---|---|
| Observed serum concentration at the end of a dosing interval (Ctau) | Over the dosing interval at Week 1 and Week 17 |
| Time of maximum observed plasma concentration (Tmax) | Over the dosing interval at Week 1 and Week 17 |
| Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) | Through Week 51 Day 1 |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 65 weeks |
| Maximum Observed Plasma Concentration (Cmax) | Over the dosing interval at Week 1 and Week 17 |
| Number of Participants With Adverse Events (AEs) | Up to 65 weeks |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 65 weeks |
| Number of Participants with AEs leading to death | Up to 65 weeks |
| Number of Participants With Adverse Events leading to Discontinuation | Up to 65 weeks |
Countries
Argentina, Australia, Brazil, Canada, Chile, France, Ireland, Italy, Mexico, New Zealand, Poland, Romania, Spain, United States
Outcome results
None listed