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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

NCT03980314

Description:

The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative to Process C.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-8FC
  • SECONDARY ID: 2018-002993-38
  • NCT ID: NCT03980314

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
NivolumabOpdivoArm A (Process C)

Purpose

The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative to Process C.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A (Process C)ExperimentalParticipants will receive nivolumab specified dose on specified days"
  • Nivolumab
Arm B (Process D)ExperimentalParticipants will receive nivolumab specified dose on specified days"
  • Nivolumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Total Body Clearance
Time Frame:At Week 17
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Number of Participants With Serious Adverse Events (SAEs) and Deaths
Time Frame:Up to Week 51
Safety Issue:
Description:
Measure:Number of Participants With Adverse Events leading to Discontinuation
Time Frame:Up to Week 51
Safety Issue:
Description:
Measure:Number of Participants With Adverse Events (AEs)
Time Frame:Up to Week 51
Safety Issue:
Description:
Measure:Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame:Up to Week 51
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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