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

Bristol-Myers Squibb37 sites in 14 countries261 target enrollmentJune 24, 2019

ConditionsMelanoma

InterventionsNivolumab

Overview

Phase: Phase 1
Intervention: Nivolumab
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 261
Locations: 37
Primary Endpoint: Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 24, 2019

End Date

November 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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

Arms & Interventions

Arm A (Process C)

Intervention: Nivolumab

Arm B (Process D)

Intervention: Nivolumab

Outcomes

Primary Outcomes

Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)

Time Frame: Over the dosing interval at Week 1 and Week 17

Secondary Outcomes

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)