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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03980314
Recruitment Status : Active, not recruiting
First Posted : June 10, 2019
Last Update Posted : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 24, 2019
Actual Primary Completion Date : March 4, 2021
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Active Comparator: Arm A (Process C) Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Arm B (Process D) Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980314


Locations
Show Show 36 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03980314    
Other Study ID Numbers: CA209-8FC
2018-002993-38 ( EudraCT Number )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action