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
- Registration Number
- NCT03980314
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (Process C) Nivolumab - Arm B (Process D) Nivolumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Observed serum concentration at the end of a dosing interval (Ctau) Over the dosing interval at Week 1 and Week 17 Number of Participants With Adverse Events leading to Discontinuation Up to 65 weeks 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 Number of Participants with AEs leading to death Up to 65 weeks Maximum Observed Plasma Concentration (Cmax) 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 Adverse Events (AEs) Up to 65 weeks Number of Participants With Clinically Significant Laboratory Abnormalities Up to 65 weeks
Trial Locations
- Locations (37)
Local Institution - 0043
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0039
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0041
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0004
🇳🇿Christchurch, New Zealand
Local Institution - 0026
🇪🇸Madrid, Spain
Local Institution - 0008
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0015
🇮🇹Padova, Italy
Local Institution - 0036
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0037
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0006
🇺🇸Hartford, Connecticut, United States
Local Institution - 0046
🇦🇷Buenos Aires, Argentina
Local Institution - 0045
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0030
🇷🇴Timisoara, Romania
Local Institution - 0040
🇧🇷São José do Rio Preto, São Paulo, Brazil
Local Institution - 0023
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0032
🇮🇪Dublin, Ireland
Local Institution - 0017
🇵🇱Warszawa, Poland
Local Institution - 0022
🇨🇱Santiago, Chile
Local Institution - 0031
🇲🇽San Pedro Garza Garcia, Nuevo LEON, Mexico
Local Institution - 0001
🇦🇺Wollstonecraft, New South Wales, Australia
Local Institution - 0035
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0038
🇧🇷Cerqueira Cesar, SAO Paulo, Brazil
Local Institution - 0013
🇨🇦Edmonton, Canada
Local Institution - 0024
🇨🇱Independencia, Santiago, Chile
Local Institution - 0010
🇫🇷Nantes Cedex 1, France
Local Institution - 0009
🇫🇷Marseille Cedex 5, France
Local Institution - 0011
🇫🇷Paris, France
Local Institution - 0018
🇮🇪Wilton, Cork, Ireland
Local Institution - 0014
🇮🇹Bergamo, Italy
Local Institution - 0016
🇮🇹Siena, Italy
Local Institution - 0005
🇳🇿Auckland, New Zealand
Local Institution - 0033
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0034
🇲🇽Tlalpan, Distrito Federal, Mexico
Local Institution - 0003
🇳🇿Wellington, New Zealand
Local Institution - 0027
🇪🇸Madrid, Spain
Local Institution - 0029
🇪🇸Badalona-barcelona, Spain
Local Institution - 0028
🇪🇸Malaga, Spain