A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
NewLink Genetics Corporation
Study ID
NCT03301636
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
  • Nivolumab — DRUG
    Nivolumab will be administered intravenously every 2 weeks starting on day 1.
  • Indoximod — DRUG
    Indoximod will be administered orally every 12 hours starting at Day 1

Study Details

This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial. The phase 3 study will not proceed per Sponsor decision.

Key Dates

Start date
Dec 8, 2017
Status verified
Sep 2022
Primary completion
Oct 21, 2019
Completion
Nov 4, 2019

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Indoximiod
  • Experimental: Nivolumab + Indoximiod

Primary Outcome Measure

Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab [ Time Frame: 28 Days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Mayo Clinic - RochesterRochesterMinnesota55905-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87102-
Utah Cancer SpecialistsSalt Lake CityUtah84102-

Find similar trials in Iowa City, IA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Iowa Hospital and Clinics· Iowa City, IAMayo Clinic - Rochester· Rochester, MNUniversity of New Mexico Comprehensive Cancer Center· Albuquerque, NMUtah Cancer Specialists· Salt Lake City, UT

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