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Completed

NCT Number: NCT03980314

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0046, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

Specified dose on specified days

Other names: Opdivo, BMS-936558

Primary outcomes

  1. 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

  1. Maximum Observed Plasma Concentration (Cmax)

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

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

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

  3. Time of maximum observed plasma concentration (Tmax)

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

  4. Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)

    Time frame: Through Week 51 Day 1

  5. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 65 weeks

  6. Number of Participants With Adverse Events leading to Discontinuation

    Time frame: Up to 65 weeks

  7. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 65 weeks

  8. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Up to 65 weeks

  9. Number of Participants with AEs leading to death

    Time frame: Up to 65 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jun 10, 2019
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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