Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

Part of paid clinical trials in Augusta, Georgia.

Sponsor
NewLink Genetics Corporation
Study ID
NCT02073123
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Indoximod — DRUG
    Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth Dose escalation: * If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled * If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects * If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease * If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
  • Ipilimumab — DRUG
    Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
  • Nivolumab — DRUG
    Nivolumab administered intravenously at 240 mg every 2 weeks.
  • Pembrolizumab — DRUG
    Pembrolizumab administered intravenously at 2 mg/kg every three weeks.

Study Details

To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma

Key Dates

Start date
Jul 31, 2014
Status verified
May 2026
Primary completion
Jan 17, 2018
Completion
Jul 3, 2019

Study Design

Enrollment
131 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Indoximod + Ipilimumab
    Indoximod will be administered at 1200mg BID by mouth. Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses. Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles). Patients will continue until they experience disease progression or limiting toxicity.
  • Experimental: Indoximod + Pembrolizumab
    Indoximod will be administered at 1200mg BID by mouth. Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
  • Experimental: Indoximod + Nivolumab
    Indoximod will be administered at 1200mg BID by mouth. Nivolumab administered intravenously at 240 mg every 2 weeks.

Primary Outcome Measure

Phase 1 Regimen Limiting Toxicity of the Combination of Indoximod and Ipilimumab [ Time Frame: 6 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Augusta UniversityAugustaGeorgia30912-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Mayo ClinicRochesterMinnesota55905-
New Mexico Cancer Center AllianceAlbuquerqueNew Mexico87106-
Penn State Hershey Cancer InstitueHersheyPennsylvania17033-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Related coverage on Hipa.ai

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By specialty
OncologySkin cancerDermatology
By research site
Augusta University· Augusta, GAUniversity of Iowa Hospital and Clinics· Iowa City, IAMayo Clinic· Rochester, MNNew Mexico Cancer Center Alliance· Albuquerque, NMPenn State Hershey Cancer Institue· Hershey, PAHuntsman Cancer Institute· Salt Lake City, UT

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