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

NCT03980314 | Completed Phase 1 FDA Drug

• 2 other identifiers: CA209-8FC2018-002993-38
• Study Type: interventional
• Target: 261
• Locations: 14 countries
• Sites: 37

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Maximum Observed Plasma Concentration (Cmax)

  Over the dosing interval at Week 1 and Week 17

• Observed serum concentration at the end of a dosing interval (Ctau)

  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 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

Study Arms (2)

Arm A (Process C)

ACTIVE COMPARATOR

Drug: Nivolumab

Arm B (Process D)

EXPERIMENTAL

Drug: Nivolumab

Interventions

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm A (Process C); Arm B (Process D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (37)

Local Institution - 0006

Hartford, Connecticut, 06106, United States

Location

Local Institution - 0008

Minneapolis, Minnesota, 55407, United States

Location

Local Institution - 0035

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0043

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0046

Buenos Aires, 1431, Argentina

Location

Local Institution - 0001

Wollstonecraft, New South Wales, 2065, Australia

Location

Local Institution - 0036

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0037

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0039

Barretos, São Paulo, 14780-070, Brazil

Location

Local Institution - 0038

Cerqueira César, São Paulo, 01246-000, Brazil

Location

Local Institution - 0040

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Local Institution - 0041

Rio de Janeiro, 20230-130, Brazil

Location

Local Institution - 0013

Edmonton, T6X 1E8, Canada

Location

Local Institution - 0024

Independencia, Santiago Metropolitan, Chile

Location

Local Institution - 0045

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0023

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0022

Santiago, 0, Chile

Location

Local Institution - 0009

Marseille, 13385, France

Location

Local Institution - 0010

Nantes, 44093, France

Location

Local Institution - 0011

Paris, 75475, France

Location

Local Institution - 0018

Wilton, CORK, T12 DC4A, Ireland

Location

Local Institution - 0032

Dublin, Ireland

Location

Local Institution - 0014

Bergamo, 24127, Italy

Location

Local Institution - 0015

Padua, 35128, Italy

Location

Local Institution - 0016

Siena, 53100, Italy

Location

Local Institution - 0034

Tlalpan, Mexico City, 14080, Mexico

Location

Local Institution - 0033

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0031

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Local Institution - 0005

Auckland, 1023, New Zealand

Location

Local Institution - 0004

Christchurch, 0, New Zealand

Location

Local Institution - 0003

Wellington, 6021, New Zealand

Location

Local Institution - 0017

Warsaw, 02-781, Poland

Location

Local Institution - 0030

Timișoara, 300696, Romania

Location

Local Institution - 0029

Badalona-barcelona, 08916, Spain

Location

Local Institution - 0026

Madrid, 28007, Spain

Location

Local Institution - 0027

Madrid, 28040, Spain

Location

Local Institution - 0028

Málaga, 29010, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: June 24, 2019
• Primary Completion: March 4, 2021
• Study Completion: November 6, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

US (4); IE (2); BR (6); AR (1); AU (1); CA (1); ME (3); IT (3); NZ (3); PL (1); RO (1); ES (4); CL (4); FR (3)