Immunotherapy Study for Patients With Stage IV Melanoma

Part of paid clinical trials in Niles, Illinois.

Sponsor
NewLink Genetics Corporation
Study ID
NCT02054520
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • HyperAcute®-Melanoma (HAM) Immunotherapy — DRUG
  • Ipilimumab — DRUG
  • Pembrolizumab — DRUG
  • Nivolumab — DRUG

Study Details

The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone, or in combination with the experimental immunotherapy drug, dorgenmeltucel-L, for melanoma. We hypothesize that this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of progression-free, disease-free or overall survival compared to the use of immune checkpoint inhibitors alone.

Key Dates

Start date
Jun 30, 2014
Status verified
Mar 2023
Primary completion
Apr 5, 2018
Completion
Jan 5, 2021

Study Design

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

Arms

  • Experimental: Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
    Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
  • Active Comparator: Arm 2A Ipilimumab Alone
    Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
  • Experimental: Arm 1B HyperAcute®-Melanoma (HAM) + nivolumab
    Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
  • Active Comparator: Arm 2B Nivolumab alone
    Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
  • Experimental: Arm 1C HyperAcute®-Melanoma (HAM) + pembrolizumab
    Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
  • Active Comparator: Arm 2C Pembrolizumab alone
    Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks

Primary Outcome Measure

Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Oncology SpecialistsNilesIllinois60714-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Kansas Cancer CenterWestwoodKansas--
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
University of Tennessee Medical CenterKnoxvilleTennessee37920-

Find similar trials in Niles, IL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Oncology Specialists· Niles, ILUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Kansas Cancer Center· Westwood, KSWake Forest Baptist Health· Winston-Salem, NCUniversity of Tennessee Medical Center· Knoxville, TN

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