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

December 14, 2023 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Local Institution - 0046
  • Australia
    • New South Wales
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0001
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Local Institution - 0041
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0036
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
        • Local Institution - 0037
    • SAO Paulo
      • Cerqueira Cesar, SAO Paulo, Brazil, 01246-000
        • Local Institution - 0038
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14780-070
        • Local Institution - 0039
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Local Institution - 0040
  • Canada
      • Edmonton, Canada, T6X 1E8
        • Local Institution - 0013
  • Chile
      • Santiago, Chile
        • Local Institution - 0022
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8420383
        • Local Institution - 0045
      • Santiago, Metropolitana, Chile
        • Local Institution - 0023
    • Santiago
      • Independencia, Santiago, Chile
        • Local Institution - 0024
  • France
      • Marseille Cedex 5, France, 13385
        • Local Institution - 0009
      • Nantes Cedex 1, France, 44093
        • Local Institution - 0010
      • Paris, France, 75475
        • Local Institution - 0011
  • Ireland
      • Dublin, Ireland
        • Local Institution - 0032
    • Cork
      • Wilton, Cork, Ireland, T12 DC4A
        • Local Institution - 0018
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0014
      • Padova, Italy, 35128
        • Local Institution - 0015
      • Siena, Italy, 53100
        • Local Institution - 0016
  • Mexico
    • Distrito Federal
      • Tlalpan, Distrito Federal, Mexico, 14080
        • Local Institution - 0034
    • Nuevo LEON
      • San Pedro Garza Garcia, Nuevo LEON, Mexico, 66278
        • Local Institution - 0031
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution - 0033
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0005
      • Christchurch, New Zealand
        • Local Institution - 0004
      • Wellington, New Zealand, 6021
        • Local Institution - 0003
  • Poland
      • Warszawa, Poland, 02-781
        • Local Institution - 0017
  • Romania
      • Timisoara, Romania, 300696
        • Local Institution - 0030
  • Spain
      • Badalona-barcelona, Spain, 08916
        • Local Institution - 0029
      • Madrid, Spain, 28007
        • Local Institution - 0026
      • Madrid, Spain, 28040
        • Local Institution - 0027
      • Malaga, Spain, 29010
        • Local Institution - 0028
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Local Institution - 0006
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Local Institution - 0008
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0035
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (Process C)
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Arm B (Process D)
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Over the dosing interval at Week 1 and Week 17

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2019

Primary Completion (Actual)

March 4, 2021

Study Completion (Actual)

November 6, 2023

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8FC
  • 2018-002993-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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