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

Phase 1

Completed

• Conditions: Melanoma
• Interventions: Drug: Nivolumab

• 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

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Study Start: 2019-06-24
• Primary Completion: 2021-03-04
• Study Completion: 2023-11-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

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 - 0006; 🇺🇸 Hartford, Connecticut, United States

Local Institution - 0008; 🇺🇸 Minneapolis, Minnesota, United States

Local Institution - 0035; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0043; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0046; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0001; 🇦🇺 Wollstonecraft, New South Wales, Australia

Local Institution - 0036; 🇧🇷 Ijui, RIO Grande DO SUL, Brazil

Local Institution - 0037; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil

Local Institution - 0039; 🇧🇷 Barretos, Sao Paulo, Brazil

Local Institution - 0038; 🇧🇷 Cerqueira Cesar, SAO Paulo, Brazil

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