A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03635983
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • NKTR-214 — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Key Dates

Start date
Sep 21, 2018
Status verified
Mar 2025
Primary completion
Nov 19, 2021
Completion
Mar 19, 2024

Study Design

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

Arms

  • Experimental: Combination
    NKTR-214 + Nivolumab
  • Experimental: Monotherapy
    Nivolumab

Primary Outcome Measure

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) [ Time Frame: From date of randomization to disease progression (Up to 37 months) ]

Locations (24)

FacilityCityStateZIPSite coordinators
Local Institution - 0187TucsonArizona85724-
Local Institution - 0014La JollaCalifornia92093-
Local Institution - 0122StanfordCalifornia94305-
Local Institution - 0051AuroraColorado80045-
Local Institution - 0065New HavenConnecticut06510-
Local Institution - 0153MiamiFlorida33136-
Local Institution - 0017Miami BeachFlorida33140-
Local Institution - 0112TampaFlorida33612-
Local Institution - 0012AtlantaGeorgia30322-1013-
Local Institution - 0019LouisvilleKentucky40202-
Local Institution - 0018BostonMassachusetts02215-
Local Institution - 0188Ann ArborMichigan48109-
Local Institution - 0186FridleyMinnesota55432-
Local Institution - 0135St LouisMissouri63110-
Local Institution - 0016HackensackNew Jersey07601-
Local Institution - 0185New BrunswickNew Jersey08903-
Local Institution - 0141New YorkNew York10065-
Local Institution - 0037ClevelandOhio44195-
Local Institution - 0011PortlandOregon97213-
Local Institution - 0013PortlandOregon97239-
St. Luke's Hospital & Health NetworkEastonPennsylvania18045-
Local Institution - 0015PhiladelphiaPennsylvania19111-
Local Institution - 0001HoustonTexas77030-
Local Institution - 0064FairfaxVirginia22031-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution - 0187· Tucson, AZLocal Institution - 0014· La Jolla, CALocal Institution - 0122· Stanford, CALocal Institution - 0051· Aurora, COLocal Institution - 0065· New Haven, CTLocal Institution - 0153· Miami, FL

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