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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

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ClinicalTrials.gov Identifier: NCT03980314
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Detailed Description:
The study is intended to compare the pharmacokinetic of Process D nivolumab to Process C nivolumab administered after complete resection of Stage IIIa/b/c/d or Stage IV melanoma.

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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 : August 26, 2021
Estimated Study Completion Date : August 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A (Process C)
Participants will receive nivolumab specified dose on specified days"
Drug: Nivolumab
Participants will receive nivolumab.
Other Name: Opdivo

Experimental: Arm B (Process D)
Participants will receive nivolumab specified dose on specified days"
Drug: Nivolumab
Participants will receive nivolumab.
Other Name: Opdivo




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Total Body Clearance [ Time Frame: At Week 17 ]
  5. 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 ]
  6. Number of Participants With Serious Adverse Events (SAEs) and Deaths [ Time Frame: Up to Week 51 ]
  7. Number of Participants With Adverse Events leading to Discontinuation [ Time Frame: Up to Week 51 ]
  8. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Week 51 ]
  9. 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
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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:

  Show 35 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     History of Changes
Other Study ID Numbers: CA209-8FC
2018-002993-38 ( EudraCT Number )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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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