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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980314
• Other study ID #: CA209-8FC
• Secondary ID: 2018-002993-38
• Status: Completed
• Phase: Phase 1
• Start date: June 24, 2019
• Est. completion date: November 6, 2023

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: November 6, 2023
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0046	Buenos Aires
Australia	Local Institution - 0001	Wollstonecraft	New South Wales
Brazil	Local Institution - 0039	Barretos	Sao Paulo
Brazil	Local Institution - 0038	Cerqueira Cesar	SAO Paulo
Brazil	Local Institution - 0036	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0037	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0041	Rio de Janeiro
Brazil	Local Institution - 0040	São José do Rio Preto	São Paulo
Canada	Local Institution - 0013	Edmonton
Chile	Local Institution - 0024	Independencia	Santiago
Chile	Local Institution - 0022	Santiago
Chile	Local Institution - 0023	Santiago	Metropolitana
Chile	Local Institution - 0045	Santiago	Metropolitana
France	Local Institution - 0009	Marseille Cedex 5
France	Local Institution - 0010	Nantes Cedex 1
France	Local Institution - 0011	Paris
Ireland	Local Institution - 0032	Dublin
Ireland	Local Institution - 0018	Wilton	Cork
Italy	Local Institution - 0014	Bergamo
Italy	Local Institution - 0015	Padova
Italy	Local Institution - 0016	Siena
Mexico	Local Institution - 0033	Monterrey	Nuevo Leon
Mexico	Local Institution - 0031	San Pedro Garza Garcia	Nuevo LEON
Mexico	Local Institution - 0034	Tlalpan	Distrito Federal
New Zealand	Local Institution - 0005	Auckland
New Zealand	Local Institution - 0004	Christchurch
New Zealand	Local Institution - 0003	Wellington
Poland	Local Institution - 0017	Warszawa
Romania	Local Institution - 0030	Timisoara
Spain	Local Institution - 0029	Badalona-barcelona
Spain	Local Institution - 0026	Madrid
Spain	Local Institution - 0027	Madrid
Spain	Local Institution - 0028	Malaga
United States	Local Institution - 0035	Charlotte	North Carolina
United States	Local Institution - 0006	Hartford	Connecticut
United States	Local Institution - 0008	Minneapolis	Minnesota
United States	Local Institution - 0043	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  France,  Ireland,  Italy,  Mexico,  New Zealand,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Observed Plasma Concentration (Cmax)		Over the dosing interval at Week 1 and Week 17
Secondary	Observed serum concentration at the end of a dosing interval (Ctau)		Over the dosing interval at Week 1 and Week 17
Secondary	Time of maximum observed plasma concentration (Tmax)		Over the dosing interval at Week 1 and Week 17
Secondary	Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)		Through Week 51 Day 1
Secondary	Number of Participants With Serious Adverse Events (SAEs)		Up to 65 weeks
Secondary	Number of Participants With Adverse Events leading to Discontinuation		Up to 65 weeks
Secondary	Number of Participants With Adverse Events (AEs)		Up to 65 weeks
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities		Up to 65 weeks
Secondary	Number of Participants with AEs leading to death		Up to 65 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting