Clinical trial NCT03980314: 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
Official title: A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-06-10
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
timeFrame: Over the dosing interval at Week 1 and Week 17
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Over the dosing interval at Week 1 and Week 17
measure: Observed serum concentration at the end of a dosing interval (Ctau)
timeFrame: Over the dosing interval at Week 1 and Week 17
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Over the dosing interval at Week 1 and Week 17
measure: Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
timeFrame: Through Week 51 Day 1
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 65 weeks
measure: Number of Participants With Adverse Events leading to Discontinuation
timeFrame: Up to 65 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 65 weeks
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Up to 65 weeks
measure: Number of Participants with AEs leading to death
timeFrame: Up to 65 weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Local Institution - 0006
state: Connecticut
city: Minneapolis
country: United States
facility: Local Institution - 0008
state: Minnesota
city: Charlotte
country: United States
facility: Local Institution - 0035
state: North Carolina
city: Pittsburgh
country: United States
facility: Local Institution - 0043
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Local Institution - 0046
city: Wollstonecraft
country: Australia
facility: Local Institution - 0001
state: New South Wales
city: Ijui
country: Brazil
facility: Local Institution - 0036
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0037
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0039
state: Sao Paulo
city: Cerqueira Cesar
country: Brazil
facility: Local Institution - 0038
state: SAO Paulo
city: São José do Rio Preto
country: Brazil
facility: Local Institution - 0040
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0041
city: Edmonton
country: Canada
facility: Local Institution - 0013
city: Santiago
country: Chile
facility: Local Institution - 0045
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0023
state: Metropolitana
city: Independencia
country: Chile
facility: Local Institution - 0024
state: Santiago
city: Santiago
country: Chile
facility: Local Institution - 0022
city: Marseille Cedex 5
country: France
facility: Local Institution - 0009
city: Nantes Cedex 1
country: France
facility: Local Institution - 0010
city: Paris
country: France
facility: Local Institution - 0011
city: Wilton
country: Ireland
facility: Local Institution - 0018
state: Cork
city: Dublin
country: Ireland
facility: Local Institution - 0032
city: Bergamo
country: Italy
facility: Local Institution - 0014
city: Padova
country: Italy
facility: Local Institution - 0015
city: Siena
country: Italy
facility: Local Institution - 0016
city: Tlalpan
country: Mexico
facility: Local Institution - 0034
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Local Institution - 0033
state: Nuevo Leon
city: San Pedro Garza Garcia
country: Mexico
facility: Local Institution - 0031
state: Nuevo LEON
city: Auckland
country: New Zealand
facility: Local Institution - 0005
city: Christchurch
country: New Zealand
facility: Local Institution - 0004
city: Wellington
country: New Zealand
facility: Local Institution - 0003
city: Warszawa
country: Poland
facility: Local Institution - 0017
city: Timisoara
country: Romania
facility: Local Institution - 0030
city: Badalona-barcelona
country: Spain
facility: Local Institution - 0029
city: Madrid
country: Spain
facility: Local Institution - 0026
city: Madrid
country: Spain
facility: Local Institution - 0027
city: Malaga
country: Spain
facility: Local Institution - 0028
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: