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 :
Recruiting
First Posted : June 10, 2019
Last Update Posted : August 10, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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Brief Summary:
The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative to Process C.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma | Drug: Nivolumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 254 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| 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 21, 2019 |
| Estimated Primary Completion Date : | March 1, 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 |
|---|---|
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Experimental: Arm A (Process C)
Participants will receive nivolumab specified dose on specified days"
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Drug: Nivolumab
Participants will receive nivolumab.
Other Name: Opdivo |
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Experimental: Arm B (Process D)
Participants will receive nivolumab specified dose on specified days"
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Drug: Nivolumab
Participants will receive nivolumab.
Other Name: Opdivo |
Primary Outcome Measures :
- Area under the concentration-time curve in one dosing interval (336 h) [ Time Frame: Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 ]
Secondary Outcome Measures :
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 ]
- Trough Observed Serum Concentration (Ctrough) [ Time Frame: Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 ]
- Volume of Distribution [ Time Frame: Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 ]
- Total Body Clearance [ Time Frame: At Week 17 ]
- Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [ Time Frame: Predose (0 hr), Week 1, 3, 17, 19, 35, and 51 of Day 1 ]
- Number of Participants With Serious Adverse Events (SAEs) and Deaths [ Time Frame: Up to Week 51 ]
- Number of Participants With Adverse Events leading to Discontinuation [ Time Frame: Up to Week 51 ]
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Week 51 ]
- Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Up to Week 51 ]
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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:
- Late Stage melanoma that is completely surgically resected and pathologically absent
- Participants must not have received anti-cancer therapy greater than equal to (>=) 6 months prior to randomization
- Imaging studies to include Computed tomography (CT), Magnetic resonance imaging (MRI), positron emission tomography (PET) scans that show no clinically detectable nodes on imaging
Exclusion Criteria:
- Participants must not have a history of ocular/uveal melanoma
- Participants with active, known, or suspected autoimmune disease(s) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Participants must not have prior malignancy active within the previous 3 years except for locally curable cancers
- Participants must not have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
- Participants must not have had prior therapy for melanoma except surgery, for the melanoma lesion(s) adjuvant radiation therapy after neurosurgical resection for CNS lesions and except for participants who received prior adjuvant interferon therapy
- Treatment directed against the resected melanoma that is administered after complete resection other than adjuvant radiation
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
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. | please email: |
Locations
Show 41 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: | August 10, 2020 |
| Last Verified: | August 2020 |
| 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 |