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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03980314
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jun 24, 2019
Status verified
Dec 2023
Primary completion
Mar 4, 2021
Completion
Nov 6, 2023

Study Design

Enrollment
261 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (Process C)
  • Experimental: Arm B (Process D)

Primary Outcome Measure

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 0006HartfordConnecticut06106-
Local Institution - 0008MinneapolisMinnesota55407-
Local Institution - 0035CharlotteNorth Carolina28204-
Local Institution - 0043PittsburghPennsylvania15213-

Find similar trials in Hartford, CT

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution - 0006· Hartford, CTLocal Institution - 0008· Minneapolis, MNLocal Institution - 0035· Charlotte, NCLocal Institution - 0043· Pittsburgh, PA

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