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
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| ClinicalTrials.gov Identifier: NCT03980314 |
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Recruitment Status :
Active, not recruiting
First Posted : June 10, 2019
Last Update Posted : May 16, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 |
| 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:
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| Experimental: Arm B (Process D) |
Drug: Nivolumab
Specified dose on specified days
Other Names:
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Primary Outcome Measures :
- 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 :
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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 ]
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: 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 ]
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 65 weeks ]
- Number of Participants With Adverse Events leading to Discontinuation [ Time Frame: Up to 65 weeks ]
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 65 weeks ]
- Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 65 weeks ]
- Number of Participants with AEs leading to death [ Time Frame: Up to 65 weeks ]
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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 36 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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 |
| 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 |